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Background: In neurological diseases presenting with a plethora of symptoms, the value of bodily functions for a given patient might be a guide for clinical management. Multiple sclerosis (MS) is paradigmatic in this respect, and little is known about the value of different bodily functions of patients and their physicians’ perceptions. Methods: In a multicenter study, 171 patients with relapsing‐remitting multiple sclerosis (RRMS), 61% with a clinically active disease within the last 2 years were followed over up to 3 years and yearly patients and their study physician rated on the perceived value of 13 bodily functions via a priority list. Differences between patients and physicians as well as modulating disease demographic factors were analyzed. Results: Patients with RRMS rated visual function followed by thinking and memory and walking highest while physicians stressed mobility, followed by thinking and memory and alertness most. Ratings were independent from disease duration or disability. Strongest value judgment differences were seen in swallowing regarded more relevant by patients and hand function regarded more relevant by physicians. In general, patients’ and physicians’ ratings through time were quite stable. Collapsing physical items into a physical functioning scale and mental items in a mental function scale, both dimensions were regarded equally important by patients while physicians underscored physical functioning (P = .016). Conclusion: There are differences between patients and physicians in value statements of bodily functions in MS. In particular, visual functioning is under‐recognized by physicians. [ABSTRACT FROM AUTHOR]

Background: Adequate risk knowledge of patients is a prerequisite for shared decision making but few attempts have been made to develop assessment tools. Multiple Sclerosis (MS) is a chronic inflammatory disease of young adults with an increasing number of partially effective immunotherapies and therefore a paradigmatic disease to study patient involvement. Objective/methods: Based on an item bank of MS risk knowledge items and patient feedback including perceived relevance we developed a risk knowledge questionnaire for relapsing remitting (RR) MS (RIKNO 1.0) which was a primary outcome measure in a patient education trial (192 early RRMS patients). Results: Fourteen of the RIKNO 1.0 multiple-choice items were selected based on patient perceived relevance and item difficulty indices, and five on expert opinion. Mean item difficulty was 0.58, ranging from 0.14 to 0.79. Mean RIKNO 1.0 score increased after the educational intervention from 10.6 to 12.4 (p = 0.0003). Selected items were particularly difficult (e.g. those on absolute risk reductions of having a second relapse) and were answered correctly in only 30% of the patients, even after the intervention. Conclusion: Despite its high difficulty, RIKNO 1.0 is a responsive instrument to assess risk knowledge in RRMS patients participating in educational interventions. [ABSTRACT FROM AUTHOR]

Abstract: Patient autonomy has been increasingly acknowledged as prerequisite for successful medical decision making in Western countries. In medical decisions with a need to involve a health professional, patient autonomy becomes apparent in the extent of patients' participation in the communication as described in the concept of shared decision making. Patient autonomy can be derived from different perspectives or goals and the focus of evaluation approaches may vary accordingly. Multiple sclerosis (MS) is a paradigmatic disease to study patient autonomy mainly because MS patients are highly disease competent and due to ambiguous evidence on many aspects of disease-related medical decision making. This review gives an overview on measurement issues in studying decision making in MS, categorized according to prerequisites, process measures and outcomes of patient autonomy. As relevant prerequisites role preferences, risk attribution, risk tolerance, and risk knowledge are discussed. Regarding processes, we distinguish intra-psychic and interpersonal aspects. Intra-psychic processes are elucidated using the theory of planned behavior, which guided development of a 30-item scale to capture decisions about immunotherapy. Moreover, a theory of uncertainty management has been created resulting in the development of a corresponding measurement concept. Interpersonal processes evolving between physician and patient can be thoroughly analyzed from different perspectives by use of the newly developed comprehensive MAPPIN'SDM inventory. Concerning outcomes, besides health related outcomes, we discuss match of preferred roles during the decision encounters (preference match), decisional conflict as well as an application of the multidimensional measure of informed choice to decisions of MS patients. These approaches provide an overview on patient-inherent and interpersonal factors and processes modulating medical decision making and health behavior in MS and beyond. [Copyright &y& Elsevier]

Abstract: Cognitive impairment is one of the most frequent symptoms in patients with multiple sclerosis (MS) but its underlying mechanisms are poorly understood. A number of pathogenetic correlates have previously been proposed including psychosocial factors (such as depression and fatigue), inflammation, neurodegeneration, and neuroendocrine dysregulation. However, these different systems have never been studied in parallel and their differential contributions to cognitive impairment in MS are unknown. We studied a well-characterized cohort of cognitively impaired (CI, n =25) and cognitively preserved (CP, n =25) MS patients based on a comprehensive neuropsychological testing battery, a test of hypothalamo–pituitary–adrenal axis functioning (dexamethasone-corticotropin-releasing hormone suppression test, Dex-CRH test) as well as peripheral blood and MRI markers of inflammatory activity. CI patients had significantly higher disability. In addition, CI patients showed higher levels of fatigue and depression. Fatigue was more closely associated with measures of attention while depression showed strongest correlations with memory tests. Furthermore, percentage of IFNγ-positive CD4+ and CD8+ T cells showed modest correlations with processing speed and working memory. MRI markers of inflammation or global atrophy were not associated with neuropsychological function. Compared to previous studies, the number of patients exhibiting HPA axis hyperactivity was very low and no correlations were found with neuropsychological function. We conclude that fatigue and depression are the main correlates of cognitive impairment, which show domain-specific associations with measures of attention and memory. [Copyright &y& Elsevier]

Background Parallel to the establishment of early treatments in multiple sclerosis (MS), new diagnostic criteria have made an earlier diagnosis possible. While there is ongoing discussion about possible benign courses and only partial effective treatments, there have been no attempts today to facilitate shared decision making on diagnostic testing between patients with suspected MS and their physicians. Objective This study describes the development and validation process of a leaflet to be presented to people with suspected MS to engage them in a diagnostic decision-making process. Methods After a qualitative study showing acceptability among five patients, the leaflet was presented to a retrospective cohort (n = 87 of which 70 replied)) of patients being diagnosed within the last 2 years as well to a prospective cohort of n = 51 patients with symptoms suggestive of MS. Results Approximately 70% of patients in the prospective as well as in the retrospective cohort wanted to be informed about a possible MS before testing, whereas 10% did not. The leaflet did not seem to elicit anxieties. The attitude to undergo diagnostic testing was not influenced by the leaflet, which can be explained by the nonexperimental design of the study. Conclusion Taken together, our findings demonstrate that early information about possible MS is warranted by patients and does not show negative side effects. Further studies on evidence-based patient information in early MS seem necessary. [ABSTRACT FROM AUTHOR]

Multiple sclerosis is a heterogeneous disease with varying clinical picture. There have been substantial efforts to develop outcome measurements for therapeutic interventions but very few studies have addressed the value of bodily functions from the patient perspective. In a randomly selected cohort of early (<5 years, n = 84) and longer lasting disease courses (>15 years, n = 82) patients we asked for a weighting of 13 bodily functions and compared results with actual disability as measured by the United Kingdom Disability Scale. Lower limb function was given the highest priority in both patient groups followed by visual functioning and cognition especially in longer lasting MS. Actual disability did not correlate with the given priorities indicating that experienced deficits do not influence the subjective ratings of bodily functions. These results underline that ambulation-focused scales in MS represent a key dimension from the patient perspective. Visual functioning should be taken more into account. [ABSTRACT FROM AUTHOR]

Optic neuritis (ON) and any other early manifestation of multiple sclerosis (MS) are referred to as clinically isolated syndrome (CIS) as long as MS is suspected. In this prospective study we aimed to determine whether diffusion tensor imaging (DTI) could quantify structural changes in patients with early MS. A total of 24 patients and 15 control subjects were prospectively followed by clinical examinations and MRI. the main inclusion criterion was presentation with ON. Patients underwent serial MRI scans: MRI1 (baseline, n=24), MRI2 (mean 6.6 months, n=24), MRI3 (mean 13.0 months, n=14), MRI4 (mean 39.4 months, n=5). Apparent diffusion coefficient (ADC) and fractional anisotropy (FA) maps were derived from DTI. Four regions of interest (ROIs) were defined in normal-appearing white matter (NAWM). In the temporal course FA decreased in the genu of the callosal body (GCC) from MRI1 to MRI4 ( P=0.005) and in the splenium of the callosal body (SCC) ( P=0.006). Patients already had lower FA values in the SCC ( P<0.01) on MRI1 compared with the controls. Patients had lower FA values in the GCC ( P<0.01) starting from MRI2. Patients with definite MS on follow-up ( n=9) showed a correlation between FA in the SCC and time ( r=−0.40, P=0.004), whereas patients without progression did not. Our findings suggest that the corpus callosum is an early site for development of anisotropy changes in MS patients with ON. There seems to be a primary FA decrease in all patients with ON that only deteriorates in the group developing definite MS. [ABSTRACT FROM AUTHOR]

Abstract: Patients and health authorities increasingly claim active roles in health care decision making processes. As immune therapies in MS are partially effective MS is a prototypic condition for a shared decision making process. The treatment of acute relapses and the initiation, change or withdrawal of so called disease-modifying treatments are key decisions in MS management. We developed two decision aids following the phased approach of the framework of increasing evidence for complex interventions for these key decisions. In prestudies we found that 80% of MS patients demand autonomous roles in treatment decisions which contrasts with a poor knowledge of risks. On the other hand MS patients are not disturbed by evidence-based, balanced complex information. MS patients do understand this kind of information and are able to transfer new abilities to other situations. Currently we study the effects of a 4-hour education programme on relapse management versus an information leaflet in controls in 150 MS patients. In a second trial with n =298 MS patients we study the effects of an evidence-based patient information on immunotherapy on decisional role preference and performance in the patient physician encounter. Results in early 2007 will show to which extent patient education with a focus on evidence-based patient information influences participation in the decision making process. [Copyright &y& Elsevier]

Summary: Multiple sclerosis (MS) is an inflammatory and degenerative disease of the CNS with an assumed autoimmune-mediated pathogenesis. Stressful life events have been hypothesized as potential triggers of disease exacerbation. Animal studies using experimental autoimmune encephalomyelitis (EAE), as a model for MS, suggest that decreased hypothalamic–pituitary–adrenal (HPA) function may play a role in the increased susceptibility and severity of the disease. Histopathological studies of the hypothalamus point to disturbances in corticotropin-releasing hormone (CRH) regulation as a result of MS lesions in this area. Functional endocrine tests (e.g., the combined Dexamethasone–CRH test) showed a disturbed negative feedback after steroid application in MS patients. Hyper- and hypoactivity of the HPA axis, have been described to be associated with more severe courses. This paper presents an overview of the evidence for a role of HPA dysfunction in EAE and MS based on stress-experimental studies. [Copyright &y& Elsevier]

Since its first description by Charcot, psychological stress has been considered a triggering factor for exacerbations in multiple sclerosis, but until recently the clinical evidence for a causal relation was weak. Over the past years, a growing number of studies have started to elucidate this association and highlight potential mechanisms, including brain-immune communication. On 5 June 2005, a panel of international researchers discussed the current evidence. This article summarizes the observational, animal experimental, as well as human experimental findings on stress regulation in MS, as well as studies on the functioning of the major stress response systems, ie, the hypothalamopituitary-adrenal (HPA) axis and the autonomous nervous system (ANS) in MS. Consensus statements from the group to these aspects are given. Research objectives and strategies are delineated, as well as clinical implications. [ABSTRACT FROM AUTHOR]

Objective – Recently, regular cognitive screening assessments have been advised in multiple sclerosis (MS). No studies have been carried out yet on the acceptability of information on cognitive deficits among MS patients. Materials and methods – Translation of an information booklet developed by a working group of European MS Rehabilitation Centers. Distribution of the booklet among 133 MS patients of two rehabilitation units and one outpatient clinic together with a one-page questionnaire. Results – The booklet was highly understandable and rated to give moderate new information. Overall, the brochure was perceived as encouraging but significantly less so ( P = 0.014) in recently diagnosed patients. Patients with subjectively perceived deficits considered the brochure to be significantly more relevant ( P = 0.002). Conclusion – Information on cognitive deficits does not increase fears even in recently diagnosed MS patients. Patients with perceived deficits found the information more relevant than others and also less familiar. Thus, it seems appropriate to offer information about cognitive impairments to MS patients. [ABSTRACT FROM AUTHOR]

Background: Fatigue is a major complaint of multiple sclerosis (MS) patients. However, little is known about its pathophysiological mechanisms. Evidence from chronic fatigue syndrome and studies on sickness behaviour suggest that immune and neuroendocrine factors may play a causative role in the development of fatigue. Methods: We compared whole blood stimulatory capacity for pro- (TNFα, IFNγ) and anti-inflammatory cytokines (IL-10) as well as hypothalamo-pituitary-adrenal (HPA) axis function in 15 MS patients with marked fatigue and 15 patients without fatigue as determined by the Fatigue Severity Scale (FSS). Results: Proinflammatory cytokines were significantly higher (TNFα: 478.9 v 228.2 pg/ml, p = 0.01; IFNγ: 57.6 v 27.8 pg/ml; p = 0.01) in MS patients with fatigue. Furthermore, TNFα values significantly correlated with daytime sleepiness as measured by the Epworth Sleepiness Scale (r = 0.64, p = 0.001). Controlling for disease activity (as measured by the Cambridge Multiple Sclerosis Basic Score), disease duration, Expanded Disability Status Scale, and depression further increased the correlation of cytokine production and fatigue. HPA axis activity was not related to fatigue but was modestly correlated with cognitive impairment. Conclusion: Our data suggest that fatigue in MS is at least partially mediated through activation of proinflammatory cytokines. In line with earlier findings, HPA axis dysfunction seems not to be relevant in MS fatigue pathogenesis but appears to be linked to cognitive impairment. Our findings suggest that increased levels of inflammatory cytokines may be involved in MS fatigue. Investigation of cytokine profiles may increase the understanding of fatigue pathogenesis in MS. [ABSTRACT FROM AUTHOR]

Köpke S, Heesen C, Kasper J, Mühlhauser I. Steroid treatment for relapses in multiple sclerosis – the evidence urges shared decision-making. Acta Neurol Scand 2004 DOI: 10.1111/j.1600-0404.2004.00284.x © Blackwell Munksgaard 2004. Therapy of acute relapses in multiple sclerosis with corticosteroids (CC) remains uncertain with respect to route, dosage and effectiveness. This makes the treatment of relapses a clinical field where ‘shared decision-making (SDM)’ could be of advantage for the patients. A prerequisite for SDM is the provision of evidence-based information for the patients. The British General Medical Council (GMC) has published ethical guidelines on seeking patients’ consent for medical interventions, formulating topics of information patients need in order to make an informed treatment decision. Medical databases were searched for evidence on the treatment of acute relapses with CC. The available evidence on relapse treatment is ambiguous and weak. It does not provide enough evidence to sufficiently inform patients following the topics formulated by the GMC. Good evidence is lacking, supporting the concept of SDM in the therapy of relapses. [ABSTRACT FROM AUTHOR]

Objectives – The need for an early disclosure of the diagnosis of multiple sclerosis (MS) has become more pressing with the publication of two recent randomized trials which have indicated that very early treatment may favourably alter the disease course. We assessed the current status of diagnostic and therapeutic information on MS from the point of view of patients and neurologists. Methods – A standardized questionnaire was sent out through the patients' self-help organization in Hamburg, Germany and to all neurologists. Results – A total of 434 of 1300 patients and 80 of 250 neurologists replied. Neurologists gave 90% of the diagnoses but only 50% of patients reported them as the major aid helping to understand the disease. Fifty per cent of patients were not informed about any form of therapy at the time of diagnosis regardless of whether their MS diagnosis was disclosed within the last 5 years or earlier. In contrast to physicians, patients voted for information about a possible MS even if the diagnosis may not yet be clear. Conclusion – From the patients' perspective, information about the diagnosis of MS should be more straightforward, and more information about therapies should be provided. [ABSTRACT FROM AUTHOR]

Quality of life (QoL) is discussed as an additional outcome measure in multiple sclerosis (MS). However, few questionnaires assessing disease specific QoL in MS have been published. On the basis of the literature and interviews with clinicians and MS patients, we have developed a disease specific QoL instrument and validated it in a broad range of patients with MS. In this study, a heterogeneous sample of n=237 MS patients completed the newly developed Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS, in German language) and a battery of already validated questionnaires. They further underwent neurological scoring and objective tests. By these means, we investigated its validity, appropriateness, internal consistency, and retest reliability. Internal consistency and retest coefficients were high and satisfied psychometric standards. Convergent and discriminant validity was supported by direction, magnitude and pattern of correlations with other health measures. HAQUAMS subscales and its total score distinguished between patient groups of varied disease severity, cognitive impairment, and affective symptomatology. No floor or ceiling effects were found in either of the HAQUAMS subscales. The HAQUAMS is a reliable, valid and appropriate instrument for QoL assessment in multiple sclerosis. Data of responsiveness are currently being obtained. [ABSTRACT FROM AUTHOR]

Objective – To investigate possible associations of soluble CD95 (sCD95) serum levels and DNA defragmentation with different MS disease stages and activities. Methods – Sera of 114 patients were analysed by an ELISA technique for sCD95. In a subgroup of 18 relapsing–remitting MS patients and controls we studied DNA fragmentation by the TUNEL‐method in CSF cytospins. Results – sCD95 was detectable in sera of MS patients, healthy controls and meningitis patients without significant differences. CSF specimens showed modest amounts of apoptotic cells in MS and controls. Conclusion – We could not demonstrate an association of MS disease course or activity with the expression of sCD95 in sera. DNA fragmentation in the CSF was not significantly enhanced compared to controls. Thus the analysed markers of programmed cell death appear not suitable to monitor MS disease courses. [ABSTRACT FROM AUTHOR]

Purpose: Research shows that persons with mild to moderate multiple sclerosis are less physically active than healthy controls even though they would benefit from it. This study focusses on the feasibility testing and process evaluation of the pilot study of ActivityMatters, a twelve-week web-based program, from Ireland, to increase physical activity in this population. Materials and Methods: The intervention was adapted to local circumstances in Hamburg, Germany and consists of eleven modules incorporating behavior change techniques. After feasibility had been confirmed, 43 persons with multiple sclerosis participated in a pilot study with a pre-post, single-group intervention design. Qualitative data was collected with questionnaires and semi structured interviews. Physical activity level and stage of change was measured quantitatively. Results: Participants had a mean age of 49.5 years (SD 9.29) and an average Patient Determined Disease Step Score of 2.2 (SD 1.47). Thirty-six participants answered the follow-up questionnaire. On average 9.8 modules were processed within 13 weeks. Each tool for behavior change was perceived as helpful except the chat group. Physical activity levels increased significantly from pre- to post intervention (p-value 0.042, Cohen's d = 0.35). Conclusions: The results indicate that Activity Matters is feasible and satisfactory and may change activity levels. IMPLICATIONS FOR REHABILITATION: Activity Matters provides a twelve-week web-based self-management program to increase PA which is feasible and well accepted by middle aged, mild to moderately impaired persons with MS. Persons with MS in this online program were pleased with the overall content and the self-regulation strategies, however some were seeking for more personal contact and interaction with the study team and other participants. Stronger individualisation of web-based programs to the diverse needs of participants remains a challenge that has to be solved in the future. [ABSTRACT FROM AUTHOR]

Interleukin-1 (IL-1) is one of the major proinflammatory cytokines expressed consistently in multiple sclerosis (MS) lesions. Interleukin-1 receptor antagonist (IL-1ra) is the only known naturally occurring specific antagonistic cytokine counteracting IL-1. Thus IL-1ra may have a downregulating potential in the disease course of MS. We analysed if circulating IL-1ra could be associated with different disease stages of MS in sera of 84 MS patients and 18 controls. IL-1ra showed considerable variations in MS patients and controls. Nevertheless we found significantly elevated serum levels in active as well as in stable disease stages compared to controls. IL-1ra levels were higher in progressive disease courses compared to relapsing–remitting MS, but not statistically significant (median: 516 versus 434 pg/ml). Further analysis with larger groups of patients and longitudinal studies will clarify if IL-1ra is useful as a prognostic serum marker in MS. [ABSTRACT FROM AUTHOR]

A correction to the article "Follow up of white matter leasions, ADC and FA," that was published in the September 11, 2008 issue, is presented.

Presents a medical case on autoimmune hyperthyroidism in multiple sclerosis under treatment with glatiramer acetate.

To evaluate a nurse-led decision coaching programme aiming to redistribute health professionals' tasks to support immunotherapy decision-making in people with multiple sclerosis (MS). Cluster-randomised controlled trial with an accompanying mixed methods process evaluation (2014 - 2018). We planned to recruit 300 people with clinically isolated syndrome or relapsing-remitting MS facing immunotherapy decisions in 15 clusters across Germany. Participants in the intervention clusters received up to three decision coaching sessions by a trained nurse and access to an evidence-based online information platform. In the control clusters, participants also had access to the information platform. The primary outcome was informed choice after six months, defined as good risk knowledge and congruent attitude and uptake. Twelve nurses from eight clusters participated in the decision coaching training. Due to insufficient recruitment, the randomised controlled trial was terminated prematurely with 125 participants (n = 42 intervention clusters, n = 83 control clusters). We found a non-significant difference between groups for informed choice favouring decision coaching: odds ratio 1.64 (95 % CI 0.49–5.53). Results indicate that decision coaching might facilitate informed decision-making in MS compared to providing patient information alone. Barriers have to be overcome to achieve structural change and successful implementation. • Structural barriers led to an early termination of the trial. • Decision coaching may facilitate decision-making in multiple sclerosis. • The intervention was well accepted by people with multiple sclerosis. • The intervention was well accepted by healthcare providers. • Multiple sclerosis nurses felt well prepared after training. [ABSTRACT FROM AUTHOR]

Severe intrathoracic injuries are uncommon but immediately life-threatening. These injuries are mostly associated with polytrauma. After stabilization of polytraumatized patients imaging is a prerequisite for treatment and operation planning. The assessment warrants an interdisciplinary approach primarily between the specialties of anesthesia, trauma surgery and thoracic surgery and further specialties should be involved depending on the injury pattern. This article gives an overview about the current management of the most important intrathoracic injuries. [ABSTRACT FROM AUTHOR]

We investigated electrophysiological correlates of fatigue in patients with multiple sclerosis (MS). Transcranial magnetic stimulation (TMS) was used to explore motor excitability in three groups of subjects: MS patients with fatigue (MS-F), MS patients without fatigue (MS-NF) and healthy control subjects. All participants had to perform a fatiguing hand-grip exercise. TMS was performed prior to and after the exercise. Prior to the motor task, MS-F patients had less inhibition in the primary motor cortex compared to both other groups. Postexercise, intracortical inhibition was still reduced in the MS-F patients compared to the MS-NF patients. In MS-F patients the postexercise time interval for normalization of the motor threshold was correlated with the fatigue severity. We conclude that MS patients with fatigue have an impairment of inhibitory circuits in their primary motor cortex. The results also indicate that fatigue severity is associated with an exercise-induced reduction of membrane excitability. [ABSTRACT FROM AUTHOR]

Buhmann C, Gbadamosi J, Heesen C. Visual recovery in a man with the rare combination of mtDNA 11778 LHON mutation and a MS-like disease after mitoxantrone therapy. Acta Neurol Scand 2002: 106: 236–239. © Blackwell Munksgaard 2002. We describe a young man with prognostic unfavourable homoplasmatic mitochondrial DNA(mt DNA) 11778 Leber's hereditary optic neuropathy (LHON) point mutation and confirmed multiple sclerosis (MS). This combination of LHON and MS-like disease is rare in both sexes, and in men has been described in only a few case reports. In a 4-year follow-up during immunosuppressive therapy with mitoxantrone, we found a remarkable time delayed visual recovery 12 months after acute onset of rapid sequential bilateral subtotal visual loss followed by episodes of isolated acute demyelinative optic neuropathy. Visual recovery to such extent after this latency is uncommon in both mtDNA 11778 LHON mutation and optic neuritis (ON) in MS. Relapses in visual deterioration must be considered as extremely rare in LHON. This case might support the hypothesis of an immunological pathogenetic factor in combined LHON and MS, and possibly in LHON alone. We suggest a search for the LHON mutation in MS patients with predominant visual impairment, independent of patients' gender. [ABSTRACT FROM AUTHOR]

Background Treatment decision-making is complex for people with multiple sclerosis. Profound information on available options is virtually not possible in regular neurologist encounters. The “nurse decision coach model” was developed to redistribute health professionals’ tasks in supporting immunotreatment decision-making following the principles of informed shared decision-making. Objectives To test the feasibility of a decision coaching programme and recruitment strategies to inform the main trial. Design Feasibility testing and parallel pilot randomised controlled trial, accompanied by a mixed methods process evaluation. Setting Two German multiple sclerosis university centres. Participants pilot trial People with suspected or relapsing-remitting multiple sclerosis facing immunotreatment decisions on first line drugs were recruited. Randomisation to the intervention (n = 38) or control group (n = 35) was performed on a daily basis. Quantitative and qualitative process data were collected from people with multiple sclerosis, nurses and physicians. Methods We report on the development and piloting of the decision coaching programme. It comprises a training course for multiple sclerosis nurses and the coaching intervention. The intervention consists of up to three structured nurse-led decision coaching sessions, access to an evidence-based online information platform (DECIMS-Wiki) and a final physician consultation. After feasibility testing, a pilot randomised controlled trial was performed. People with multiple sclerosis were randomised to the intervention or control group. The latter had also access to the DECIMS-Wiki, but received otherwise care as usual. Nurses were not blinded to group assignment, while people with multiple sclerosis and physicians were. The primary outcome was ‘informed choice’ after six months including the sub-dimensions’ risk knowledge (after 14 days), attitude concerning immunotreatment (after physician consultation), and treatment uptake (after six months). Quantitative process evaluation data were collected via questionnaires. Qualitative interviews were performed with all nurses and a convenience sample of nine people with multiple sclerosis. Results 116 people with multiple sclerosis fulfilled the inclusion criteria and 73 (63%) were included. Groups were comparable at baseline. Data of 51 people with multiple sclerosis (70%) were available for the primary endpoint. In the intervention group 15 of 31 (48%) people with multiple sclerosis achieved an informed choice after six months and 6 of 20 (30%) in the control group. Process evaluation data illustrated a positive response towards the coaching programme as well as good acceptance. Conclusions The pilot-phase showed promising results concerning acceptability and feasibility of the intervention, which was well perceived by people with multiple sclerosis, most nurses and physicians. Delegating parts of the immunotreatment decision-making process to trained nurses has the potential to increase informed choice and participation as well as effectiveness of patient-physician consultations. [ABSTRACT FROM AUTHOR]

Background and purpose: New diagnostic criteria of multiple sclerosis (MS) increase the number of patients being diagnosed with MS whilst a substantial part might not convert to clinically definite MS (CDMS). The diagnostic accuracy of the McDonald 2005 and 2010 criteria for conversion to CDMS was evaluated in an unselected cohort of patients in whom an MS diagnostic work‐up was decided. Methods: Clinical, magnetic resonance imaging and cerebrospinal fluid data were analysed for all patients who presented with symptoms suspicious for MS at the university based MS outpatient clinic between 2006 and 2010 (n = 165). Results: Follow‐up was available for 131 patients. During the mean follow‐up period of 2 years, 19% of patients developed CDMS whereas 64% of the patients fulfilling McDonald 2010 criteria did not convert to CDMS. Conclusion: The low clinical conversion rate indicates that the new diagnostic criteria may increase the incidence of MS cases with a less active disease course. [ABSTRACT FROM AUTHOR]

Background and purpose Many patients with multiple sclerosis ( MS) report a worsening of symptoms due to high ambient temperatures, but objective data about this association are rare and contradictory. The aim of this study was to investigate the influence of ambient temperature on standard clinical tests. Methods We extracted the Symbol Digit Modality Test, Nine Hole Peg Test, Timed 25 Foot Walk (T25 FW), Timed Tandem Walk, Expanded Disability Status Scale ( EDSS) and quality-of-life items on cognition, fatigue and depression from our clinical database and matched them to historical temperatures. We used linear mixed-effect models to investigate the association between temperature and outcomes. Results A total of 1254 patients with MS (mean age, 42.7 years; 69.9% females; 52.1% relapsing-remitting MS, mean EDSS, 3.8) had 5751 assessments between 1996 and 2012. We observed a worsening in the T25 FW with higher ambient temperatures in moderately disabled patients ( EDSS ≥ 4) but not in less disabled patients. However, an increase of 10°C prolonged the T25 FW by just 0.4 s. Other outcomes were not associated with ambient temperatures. Conclusions Higher ambient temperature might compromise walking capabilities in patients with MS with a manifest walking impairment. However, effects are small and not detectable in mildly disabled patients. Hand function, cognition, mood and fatigue do not appear to be correlated with ambient temperature. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effectiveness of a multi-component evidence-based education programme on disease modifying therapies in multiple sclerosis. Design: Controlled trial with two consecutive patient cohorts and a gap of two months between cohorts. Setting: Three neurological rehabilitation centres. Subjects: Patients with multiple sclerosis within rehabilitation. Interventions: Control group (CG) participants were recruited and received standard information. Two months later, intervention group (IG) participants were recruited and received a six-hour nurse-led interactive group education programme consisting of two parts and a comprehensive information brochure. Main measures: Primary endpoint was "informed choice", comprising of adequate risk knowledge in combination with congruency between attitude towards immunotherapy and actual immunotherapy uptake. Further outcomes comprised risk knowledge, decision autonomy, anxiety and depression, selfefficacy, and fatigue. Results: A total of 156 patients were included (IG=75, CG=81). The intervention led to significantly more participants with informed choice (IG: 47% vs. CG: 23%, P=0.004). The rate of persons with adequate risk knowledge was significantly higher in the IG two weeks after the intervention (IG: 54% vs. CG: 31%, P=0.007), but not after six months (IG: 48% vs. CG: 31%, P=0.058). No significant differences were shown for positive attitude towards disease modifying therapy (IG: 62% vs. CG: 71%,P=0.29) and for disease modifying therapy status after six months (IG: 61.5% vs CG: 68.6%, P=0.39). Also no differences were found for autonomy preferences and decisional conflict after six months. Conclusion: Delivering evidence-based information on multiple sclerosis disease modifying therapies within a rehabilitation setting led to a marked increase of informed choices. [ABSTRACT FROM AUTHOR]

Background: Autologous hematopoietic stem cell transplantation (aHSCT) is still not the standard treatment for highly inflammatory multiple sclerosis (MS). Even though randomized controlled trials are lacking, predictors for treatment response have been established. Since 2007, ten patients have received aHSCT in Hamburg. Objective: To present observational data from patients treated in Hamburg and a review of the literature. Methods: Descriptive statistics were used for evaluating the course of the expanded disability status scale (EDSS) as a measure for clinical outcome, magnetic resonance imaging (MRI) and neuropsychology. New gadolinium and T2-MRI uptake lesions per scan were compared. In addition, a systematic review of the currently available literature was performed. Results: The Hamburg series can be divided in two groups, one group including four patients with chronic progressive MS with low inflammatory activity (median EDSS = 6.25, 0.5 relapses per year, no gadolinium-enhancing lesions) and the other group including six patients with mild to moderate disability, relapses and inflammatory activity (median EDSS = 4.25, 1 relapse per year, 2 gadolinium-enhancing lesions). The median follow-up was 2.4 years. While the first group did not seem to benefit from aHSCT, an improvement in five out of six patients was observed in the second group. New T2 lesions occurred within the first 6 months but gadolinium-enhancing lesions were not observed (p < 0.05). A systematic literature search identified a higher efficacy of aHSCT in younger, less disabled MS patients with inflammatory activity, similar to the findings from Hamburg. Conclusion: Cohort reports describe aHSCT as a safe and efficient treatment option in highly inflammatory MS. Based on these data aHSCT seems to be a reasonable option in selected patients with highly inflammatory MS but a randomized controlled trial is warranted. [ABSTRACT FROM AUTHOR]

Background: Ecological validity implicates in how far clinical assessments refer to real life. Short clinical gait tests up to ten meters and 2- or 6-Minutes Walking Tests (2MWT/6MWT) are used as performance-based outcomes in Multiple Sclerosis (MS) studies and considered as moderately associated with real life mobility. Objective: To investigate the ecological validity of 10 Meter Walking Test (10mWT), 2MWT and 6MWT. Methods: Persons with MS performed 10mWT, 6MWT including 2MWT and 7 recorded days by accelerometry. Ecological validity was assumed if walking tests represented a typical walking sequence in real-life and correlations with accelerometry parameters were strong. Results: In this cohort (n=28, medians: age=45, EDSS=3.2, disease duration=9 years), uninterrupted walking of 2 or 6 minutes occurred not frequent in real life (2.61 and 0.35 sequences/day). 10mWT correlated only with slow walking speed quantiles in real life. 2MWT and 6MWT correlated moderately with most real life walking parameters. Conclusion: Clinical gait tests over a few meters have a poor ecological validity while validity is moderate for 2MWT and 6MWT. Mobile accelerometry offers the opportunity to control and improve the ecological validity of MS mobility outcomes. [ABSTRACT FROM AUTHOR]

Background Mobility assessment in Multiple Sclerosis (MS) is crucial for trials and individual patient counseling. Up to now, standard tests as the Timed 25-Foot Walk (T25FW) are restricted by floor effects in mildly disabled patients. The 3-meter Timed Tandem Walk (TTW) as a possibly more sensitive measure has not been investigated yet. Objective To investigate sensitivity and specificity of the TTW and T25FW to detect mild clinical impairment in a large cohort of MS patients. Methods We extracted T25FW, TTW and EDSS from our UMC patient database (2009–2012). After randomization into an explorative (n = 497) and validation (n = 228) cohort, we calculated change rates and performed ROC analyses of gait tests and EDSS including Functional System Scores. Results Between disability stages of EDSS 0–2.5 and EDSS 3.0–4.0, the mean TTW difference was 4 s (T25FW = 0.9 s). The accuracy to separate between EDSS groups was moderate but identical for both tests (ROC–AUC T25FW = 0.79, TTW = 0.80, p = 0.4). TTW had a higher sensitivity and specificity to differentiate between asymptomatic and symptomatic patients concerning FS motor/cerebellar scores (ROC–AUC T25FW = 0.71, TTW = 0.75, p < 0.05). All hypotheses could be validated in the second cohort. Conclusion A 3-m Timed Tandem Walk is a standardized test that is easy to implement to detect impairment of the motor or cerebellar system in fully ambulatory MS patients. Based on the complex-task character, TTW is a potential new outcome measure for MS mobility in mildly disabled patients and can act as easily accessible and significant additional information in patient counseling. [ABSTRACT FROM AUTHOR]

The article presents a study which investigates the potential of standardized exercise to function as a therapeutic intervention for progressive multiple sclerosis (MS) through a randomized, controlled pilot trial. Details about the methods of the study are provided. The study suggests aerobic training as feasible and beneficial for patients with progressive MS.

Background Patient-reported outcome measurements ( PROMS) have been proposed sensitive outcome parameters in multiple sclerosis ( MS). In this study, we assessed a German version of the Multiple Sclerosis Impact Scale ( MSIS-29) and a revised version of the Hamburg Quality of Life Questionnaire in Multiple Sclerosis ( HAQUAMS) in comparison with rater- and physician-based tools. Methods Consecutive MS patients ( n = 117) of the MS outpatient unit were included. In addition to MSIS-29 and HAQUAMS, the following parameters were obtained: Expanded Disability Status Scale ( EDSS) and modified Multiple Sclerosis Functional Composite ( MSFC) [9-hole peg test (9 HPT), 25-foot walk test and symbol digit modalities test]. We investigated validity, internal consistency and test-retest reliability as well as correlation between these measures. Results Internal consistency (Cronbach's α ≤ 0.96) and test-retest coefficients ( ICC ≤ 0.87) of both scales were high and satisfied psychometric standards. Convergent and discriminant validity was supported by direction, magnitude and pattern of correlation with other rater-based measures depending on the functional subdomain. Both MSIS-29 and HAQUAMS correlated with EDSS (ρ = 0.55 vs 0.62), but stronger correlation was found between MSIS-29 and HAQUAMS total score (ρ = 0.90). Both scales distinguished between patient groups of varied disease severity and cognitive impairment. Conclusion Patient-reported outcome measurements as MSIS-29 and HAQUAMS seem to be valid instruments to detect different impairment levels in comparison with traditional rater-based instruments like EDSS or MSFC. [ABSTRACT FROM AUTHOR]

The article presents a study which aims to conduct retrospective cohort study to estimate the perception and risk awareness of multiple sclerosis (MS) patients which treated motoxantrone in Hamburg, Germany. The study made use of an wilcoxon rank-sum test to compare knowledge and risk awareness before reading the brochure.The results of the study show that the accuracy of LK risk estimation increased by reading the information.

Objective The T2′ imaging has been shown to be sensitive to oxygen saturation changes in normal appearing white and grey matter ( NAWM, NAGM) in patients with relapsing-remitting multiple sclerosis ( RRMS). We aimed to explore the presence and extent of T2′ changes in patients with a clinically isolated syndrome ( CIS) and a possible association of T2′ with conventional magnetic resonance imaging and clinical outcomes. Material and methods Quantitative T2- and T2*-weighted images were acquired in 32 treatment-naive patients with a CIS within 3 months of presentation and 15 age-matched healthy controls ( HC). Quantitative T2′ values were determined in six regions of interest ( ROIs). Results The T2′ values in CIS did not differ significantly from those in HC. Among patients, T2′ values correlated positively with the T2 lesion volume ( T2 LV, r = 0.34, P < 0.05). T2′ values of the frontal NAWM correlated with the T2 LV ( r = 0.35, P < 0.05) and T2 lesion count ( r = 0.4, P = 0.02). Conclusion As opposed to RRMS, patients with CIS did not show T2′ alterations compared to HC. However, the association between the T2 LV and higher T2′ values suggests that T2′ reflects disease evolution. In CIS metabolic changes might be masked by compensatory mechanisms and become overt when disease progresses as has been shown for RRMS patients. [ABSTRACT FROM AUTHOR]

In many neurological diseases a depressive syndrome is a characteristic sign of the primary disease or is an important comorbidity. Post-stroke depression, for example, is a common and relevant complication following ischemic brain infarction. Approximately 4 out of every 10 stroke patients develop depressive disorders in the course of the disease which have a disadvantageous effect on the course and the prognosis. On the other hand depression is also a risk factor for certain neurological diseases as was recently demonstrated in a meta-analysis of prospective cohort studies which revealed a much higher stroke risk for depressive patients. Furthermore, depression plays an important role in other neurological diseases with respect to the course and quality of life, such as Parkinson's disease, multiple sclerosis and epilepsy. This article gives a review of the most important epidemiological, pathophysiological and therapeutic aspects of depressive disorders as a comorbidity of neurological diseases and as a risk factor for neurological diseases. [ABSTRACT FROM AUTHOR]

Roesner S, Appel R, Gbadamosi J, Martin R, Heesen C. Treatment of steroid-unresponsive optic neuritis with plasma exchange. Acta Neurol Scand: 2012: 126: 103-108. © 2011 John Wiley & Sons A/S. Objectives - Until now, the significance of plasma exchange (PE) as a treatment for steroid-unresponsive optic neuritis (ON) is still unclear because placebo-controlled and larger studies are missing. We report our experience with 23 patients treated by PE due to steroid-unresponsive ON. Materials and methods - Patients were admitted to the University Medical Center Hamburg-Eppendorf between 2006 and 2010 with a visual acuity of <50% on the affected eye following steroid treatment. Ten patients suffered from RR-MS, one from neuromyelitis optica, and 12 patients developed ON as a clinically isolated syndrome. Routinely, they were treated with five cycles of PE. Visual acuity was measured before and directly after PE and during follow-up (first follow-up after 50 days, second follow-up after 174 days). Results - Altogether, 70% of our patients improved after PE, 69% of them showed a good or very good response to therapy. Patients who improved well after PE ( n = 11) showed a mean visual acuity of 16% before PE compared to 45% immediately after PE and 60% at the first follow-up. No serious adverse events occurred. Conclusions - To our knowledge, our study is the largest case series of patients with steroid-unresponsive ON treated with PE. Based on our experience, we conclude that PE is an important treatment option for patients with steroid-unresponsive ON although placebo-controlled studies are missing until now. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To study the implementation of a patient education program on relapses and relapse therapy into routine care. METHODS: 31 health care professionals took part in a one day train-the-trainer program (TTTP) and subsequently 261 persons with MS (pwMS) took part in the education program. Evaluation was carried out in trainers and pwMS. RESULTS: Participants (health professionals) in the TTTP understood the program's main goals and reported that the TTTP enabled them to successfully perform the program. The majority of participants in the program (pwMS) understood the core messages. Also, they showed increased risk knowledge and increased decision autonomy preferences. Treatment decisions were reported as autonomous or as 'informed choice' in 49%, and as 'shared decisions' by 45%. Overall, effects were less marked compared to the results of the underlying randomized-controlled trial. CONCLUSION: PwMS! appreciate evidence-based information about relapse management and view the unbiased presentation of scientific uncertainty as a chance for decision autonomy. PRACTICE IMPLICATIONS: The implementation study confirms the program's transferability into clinical practice. [ABSTRACT FROM AUTHOR]

Schäffler N, Köpke S, Winkler L, Schippling S, Inglese M, Fischer K, Heesen C. Accuracy of diagnostic tests in multiple sclerosis - a systematic review. Acta Neurol Scand: 2011: 124: 151-164. © 2010 John Wiley & Sons A/S. New diagnostic criteria for multiple sclerosis (MS) have been recently proposed and further updates are upcoming. This systematic literature review summarizes diagnostic studies in suspected MS to clarify the value of diagnostic tests. We included studies of at least 40 patients followed up for 2 years. All studies are limited by the fact that no gold standard to validate diagnostic tests is available. A second relapse is used as a surrogate in relapsing-remitting MS, but long follow-up of at least 5 years is necessary to detect all cases. Many studies showed selection bias, partly because of the vague definition of a clinically isolated syndrome. Based on these limitations, sensitivity of magnetic resonance imaging (MRI) criteria was between 35% and 100%, and specificity was between 36% and 92%. Cerebrospinal fluid (CSF) oligoclonal banding showed sensitivities between 69% and 91% with specificities between 59% and 94%. Combination studies of MRI and CSF indicate enhanced sensitivity (56-100%) and specificity (53-96%). Studies on evoked potentials did not justify conclusions about their value. A combination of simplified MRI criteria with CSF might be the best approach for an early MS diagnosis. However, the value of a very early diagnosis stays questionable as patients' benefit of new diagnostic criteria has never been addressed. [ABSTRACT FROM AUTHOR]

Objective: To reassess the effect of modafinil, a wakefulness-promoting artificial psychostimulant, on fatigue and neuropsychological measures in patients with multiple sclerosis.Methods: Multiple sclerosis (MS) patients with a baseline score of ≥4 on the Fatigue Severity Scale (FSS) and an Expanded Disability Status Scale score <7 were eligible for the 8-week randomized, double-blind, placebo-controlled study. Modafinil was dosed up to 200 mg/day within 1 week. Assessments were performed at baseline and after 4 and 8 weeks. The primary outcome parameter was the mean change of the FSS mean score. Secondary outcome variables were other questionnaires covering fatigue, daytime sleepiness and sleep quality. Cognitive impairment was assessed by the oral version of the Symbol Digit Modalities Test (SDMT) and the Paced Auditory Serial Addition Test (PASAT).Results: The study included 121 MS patients. Dropout rate was 9%. Both treatment groups showed improvements through time. While mean FSS at 8 weeks showed a trend difference between groups in the intention-to-treat analysis, the primary endpoint was not met. Assessment of cognitive impairment by SDMT and PASAT showed contradictory results. All other secondary endpoints were not met. There was no major safety concern.Conclusions: In general, the study does not support modafinil as an effective treatment for MS fatigue. However, the study shows the need for new study designs and endpoints in MS fatigue studies. [ABSTRACT FROM AUTHOR]

Background Contrary to strong recommendations for high-dose intravenous corticosteroid treatment for relapses in multiple sclerosis (MS), uncertainty remains about most aspects of relapse management. Oral corticosteroids administered by physicians or patients themselves or no corticosteroids also appear justifiable. Objective To evaluate an education program that aims to involve patients with MS in decisions on relapse management. Methods In three German MS centers, 150 patients with relapsing MS were randomly assigned to a single, 4-h group session or a standard information leaflet. The primary outcome measure was the proportion of relapses with oral or no corticosteroid therapy as an indicator of patient autonomy in treatment decision making. Other outcomes included perceived decision autonomy, quality of life, and disability status. Results In the intervention group (IG), 108/139 (78%) relapses were treated with oral or no corticosteroids compared with 101/179 (56%) in the control group; P < 0.0001. Patients' perceived autonomy of treatment decision making was significantly higher in the IG; P < 0.0001. Quality of life, disability status, and adverse events of corticosteroid therapies were comparable. Conclusion The patient education program led to more autonomous decision making in patients with relapsing MS. Relevant changes in relapse management were observed. [ABSTRACT FROM AUTHOR]

Background and purpose: To evaluate the effects of an evidence-based patient decision aid (DA) on multiple sclerosis (MS) immunotherapy. Methods: Two hundred and ninety-seven MS patients who were considering or reconsidering immunotherapy participated in a randomized community-based controlled trial in Germany. An intervention group (IG) received the DA and a control group (CG) received standard information. Primary outcome measure was the match between the patient’s preferred and actual roles during consultation with the physician. Secondary end-point was treatment choice. The course of the decision-making process and patients` evaluation of the decision were also evaluated. Data were collected at baseline, after receiving the information, after consultation with the physician and 6 months after baseline. Results: The percentage of preference matches did not differ between groups (IG 49%, CG 51%, P = 0.71). There were no differences in immunotherapy choices between groups. IG patients temporarily became more critical of immunotherapy and rated the information as significantly more helpful. Conclusions: Although the intervention led to intensified processing of the information it affected neither the roles adopted in physician–patient encounters nor the immunotherapy choices made. Providing patients with balanced information may not be sufficient to alter the decision-making process. [ABSTRACT FROM AUTHOR]

In patients with relapsing-remitting multiple sclerosis (MS), IVIG was shown to reduce the relapse rate and progression of disability. In patients with chronic progressive MS, a beneficial effect of IVIG was not documented in placebo controlled studies. This trial investigated the influence of IVIG in primary (PPMS) and secondary (SPMS) chronic progressive MS. Two-hundred and thirty-one patients stratified for PPMS (n=34) and SPMS (n=197) were randomly assigned to IVIG 0.4 g/kg per month or to placebo for 24 months. Primary endpoints were 1) the time to sustained progression of disease identified as worsening of the expanded disability status scale (EDSS) sustained for 3 months, and 2) the improvement of neurological functions defined by a patient's best EDSS score. Secondary endpoints were the proportion of patients with sustained progression, the relapse rate, the assessmentof fine motor skills, visual evoked potentials, contrast sensitivity, depression and quality of life. Analysis of the intention-to-treat (ITT) population of combined PPMS and SPMS patients showed that the mean time to sustained progression was 74 weeks in the IVIG compared with 62 weeks in the placebo group (P=0.0406). When PPMS and SPMS patients were analysed separately, the time to sustained progression was also longer in the IVIG group, but the difference was not significant. There was no IVIG-mediated improvement in neurological functions. In the combined per protocol (PP) treated patients, IVIG treatment prolonged time to sustained progression by 13 weeks (P=0.0396). PPMS patients, but not SPMS patients showed a slight favourable IVIG effect on the best EDSS score. In the combined ITT population there were less patients with sustained progression in the IVIG than in the placebo group (P=0.028). The difference was significant in PPMS (P=.016), but not in SPMS patients. In the combined PP population, there was a trend for a favorable IVIG effect on the rates of patients with sustained progression. In patients with PPMS, this IVIG effect reached significance (P=0.036). Other secondary endpoints did not show significant differences between treatment groups. Eighteen patients with PPMS and 102 patients with SPMS withdrew from the study for various reasons. Treatment was generally well tolerated. It was concluded that monthly IVIG infusion could delay progression of disease in patients with PPMS, and that there was a trend in favour of IVIG treatment in patients with SPMS. [ABSTRACT FROM AUTHOR]

OBJECTIVE: This study analysis the comprehension and emotional responses of people suffering from multiple sclerosis when provided with an evidence-based information module. It is a core module of a comprehensive decision aid about immunotherapy. The core module is designed to enable patients to process scientific uncertainty without adverse effects. It considers existing standards for risk communication and presentation of data. METHODS: Using a mailing approach we investigated 169 patients with differing courses of disease in a before-after design. Items addressed the competence in processing relative and absolute risk information and patients' emotional response to the tool, comprising grade of familiarity with the information, understanding, relevance, emotional arousal, and certainty. RESULTS: Overall, numeracy improved (p < 0.001), although 99 of 169 patients did not complete the numeracy task correctly. Understanding depended on the relevance related to the course of disease. A moderate level of uncertainty was induced. No adverse emotional responses could be shown, neither in those who did comprehend the information, nor in those who did not develop numeracy skills. CONCLUSION: In conclusion, the tool supports people suffering from multiple sclerosis to process evidence-based medical information and scientific uncertainty without burdening them emotionally. PRACTICE IMPLICATIONS: This study is an example for the documentation of an important step in the development process of a complex intervention. [ABSTRACT FROM AUTHOR]

Cerebellar tremor is a frequent and disabling symptom in multiple sclerosis (MS) patients. Supportive pharmacological treatment with different drugs showed only minor effects in a few studies and in clinical practice. Encouraged by previous studies with ondansetron, a 5HT3-antagonist, we conducted a small open-label, prospective and controlled study with 14 MS patients suffering predominantly from cerebellar tremor of the upper extremities. Principal outcome measure to evaluate a functional improvement of the single intravenous administered ondansetron injection was the subject performance in the 9-hole-peg-test (9HPT) and 3 blind assessed upper extremity writing and copying tasks. We neither found significant improvement in the upper extremity tests nor in the subjective response of the patients. In conclusion we could not confirm a beneficial effect of ondansetron on cerebellar tremor of MS patients. [ABSTRACT FROM AUTHOR]