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1. The consequences of the new European reclassification of non-invasive brain stimulation devices and the medical device regulations pose an existential threat to research and treatment: An invited opinion paper

Author

Antal, A, Ganho-Avila, A, Assecondi, S, Barbour, T, Bjekic, J, Blumberger, D, Bolognini, N, Brunelin, J, Chanes, L, Dale, M, Dubbioso, R, D'Urso, G, Filipcic, I, Filipovic, S, Hirnstein, M, Konings, F, Langguth, B, Leocani, L, Sorkhabi, M, Mulder, M, Nikander, M, Nowak, R, Oliviero, A, Onarheim, B, O'Shea, J, Pallanti, S, Rachid, F, Rajao-Saraiva, J, Rossi, S, Sack, A, Sauvaget, A, van der Scheer, R, Schellhorn, K, Soria-Frisch, A, Szekely, D, Tankisi, H, C, J, Tendolkar, I, Uusitalo, S, Baeken, C, Antal A., Ganho-Avila A., Assecondi S., Barbour T., Bjekic J., Blumberger D. M., Bolognini N., Brunelin J., Chanes L., Dale M., Dubbioso R., D'Urso G., Filipcic I., Filipovic S. R., Hirnstein M., Konings F., Langguth B., Leocani L., Sorkhabi M. M., Mulder M., Nikander M., Nowak R., Oliviero A., Onarheim B., O'Shea J., Pallanti S., Rachid F., Rajao-Saraiva J., Rossi S., Sack A. T., Sauvaget A., van der Scheer R., Schellhorn K., Soria-Frisch A., Szekely D., Tankisi H., CJ. Taylor P., Tendolkar I., Uusitalo S., Baeken C., Antal, A, Ganho-Avila, A, Assecondi, S, Barbour, T, Bjekic, J, Blumberger, D, Bolognini, N, Brunelin, J, Chanes, L, Dale, M, Dubbioso, R, D'Urso, G, Filipcic, I, Filipovic, S, Hirnstein, M, Konings, F, Langguth, B, Leocani, L, Sorkhabi, M, Mulder, M, Nikander, M, Nowak, R, Oliviero, A, Onarheim, B, O'Shea, J, Pallanti, S, Rachid, F, Rajao-Saraiva, J, Rossi, S, Sack, A, Sauvaget, A, van der Scheer, R, Schellhorn, K, Soria-Frisch, A, Szekely, D, Tankisi, H, C, J, Tendolkar, I, Uusitalo, S, Baeken, C, Antal A., Ganho-Avila A., Assecondi S., Barbour T., Bjekic J., Blumberger D. M., Bolognini N., Brunelin J., Chanes L., Dale M., Dubbioso R., D'Urso G., Filipcic I., Filipovic S. R., Hirnstein M., Konings F., Langguth B., Leocani L., Sorkhabi M. M., Mulder M., Nikander M., Nowak R., Oliviero A., Onarheim B., O'Shea J., Pallanti S., Rachid F., Rajao-Saraiva J., Rossi S., Sack A. T., Sauvaget A., van der Scheer R., Schellhorn K., Soria-Frisch A., Szekely D., Tankisi H., CJ. Taylor P., Tendolkar I., Uusitalo S., and Baeken C.

Abstract

A significant amount of European basic and clinical neuroscience research includes the use of transcranial magnetic stimulation (TMS) and low intensity transcranial electrical stimulation (tES), mainly transcranial direct current stimulation (tDCS). Two recent changes in the EU regulations, the introduction of the Medical Device Regulation (MDR) (2017/745) and the Annex XVI have caused significant problems and confusions in the brain stimulation field. The negative consequences of the MDR for non-invasive brain stimulation (NIBS) have been largely overlooked and until today, have not been consequently addressed by National Competent Authorities, local ethical committees, politicians and by the scientific communities. In addition, a rushed bureaucratic decision led to seemingly wrong classification of NIBS products without an intended medical purpose into the same risk group III as invasive stimulators. Overregulation is detrimental for any research and for future developments, therefore researchers, clinicians, industry, patient representatives and an ethicist were invited to contribute to this document with the aim of starting a constructive dialogue and enacting positive changes in the regulatory environment.

Published
2024

2. Childhood Trauma increases suicidal behaviour in a treatment-resistant depression population: a FACE-DR report

Author

Aouizerate, B., Bennabi, D., Leboyer, M., Haffen, E., Llorca, P.M., Barteau, V., Bensalem, S., Laouamri, H., Souryis, Karmene, Mallet, L., Yon, L., Petrucci, J., Genty, J.B., Yrondi, A., Pierre, D., Schmitt, L., Sarrail, M., Bennabi, Djamila, Ryff, I., Beuchet, E., Tio, G., Cappe, C., Clerc, E., Garnier, M., Honciuc, R.M., Allauze, E., Blanc, O., Bellivier, F., Allaili, N., Nieto, I., Meheust, J., Sunthavy, Y., Maruani, J., Bougerol, T., Polosan, M., Courvoisier, P., Holtzmann, J., Fredembach, B., Foubert-Andreani, S., Camus, V., El Hage, W., D’Amato, T., Haesebaert, F., Dubien, C., Lefebvre, M., Meznad, A., Brunelin, J., Moirand, R., Doumy, O., Lancon, C., Richieri, R., Peri, P., Faugere, M., Faget-Agius, C., Courtet, P., Boulenger, J.P., Moliere, F., Stephan, F., Walter, M., Mesmeur, C., Vaiva, G., Horn, M., Yrondi, Antoine, Vaiva, Guillaume, Walter, Michel, D Amato, Thierry, Bellivier, Frank, Bougerol, Thierry, Camus, Vincent, Doumy, Olivier, Genty, Jean-Baptiste, Haffen, Emmanuel, Holtzmann, Jérôme, Horn, Mathilde, Lançon, Christophe, Leboyer, Marion, Llorca, Pierre-Michel, Maruani, Julia, Moirand, Rémi, Molière, Fanny, Petrucci, Jean, Richieri, Raphaelle, Samalin, Ludovic, Schmitt, Laurent, Stephan, Florian, Courtet, Philippe, El-Hage, Wissam, and Aouizerate, Bruno

Published
2021
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7. Digitalized transcranial electrical stimulation: A consensus statement

Author

Brunoni, A. R., Ekhtiari, H., Antal, A., Auvichayapat, P., Baeken, C., Bensenor, I. M., Bikson, M., Boggio, P., Borroni, B., Brighina, F., Brunelin, J., Carvalho, S., Caumo, W., Ciechanski, P., Charvet, L., Clark, V. P., Cohen Kadosh, R., Cotelli, Maria, Datta, A., Deng, Z. -D., De Raedt, R., De Ridder, D., Fitzgerald, P. B., Floel, A., Frohlich, F., George, M. S., Ghobadi-Azbari, P., Goerigk, S., Hamilton, R. H., Jaberzadeh, S. J., Hoy, K., Kidgell, D. J., Zonoozi, A. K., Kirton, A., Laureys, S., Lavidor, M., Lee, K., Leite, J., Lisanby, S. H., Loo, C., Martin, D. M., Miniussi, C., Mondino, M., Monte-Silva, K., Morales-Quezada, L., Nitsche, M. A., Okano, A. H., Oliveira, C. S., Onarheim, B., Pacheco-Barrios, K., Padberg, F., Nakamura-Palacios, E. M., Palm, U., Paulus, W., Plewnia, C., Priori, A., Rajji, T. K., Razza, L. B., Rehn, E. M., Ruffini, G., Schellhorn, K., Zare-Bidoky, M., Simis, M., Skorupinski, P., Suen, P., Thibaut, A., Valiengo, L. C. L., Vanderhasselt, M. -A., Vanneste, S., Venkatasubramanian, G., Violante, I. R., Wexler, A., Woods, A. J., Fregni, F., Cotelli M., Brunoni, A. R., Ekhtiari, H., Antal, A., Auvichayapat, P., Baeken, C., Bensenor, I. M., Bikson, M., Boggio, P., Borroni, B., Brighina, F., Brunelin, J., Carvalho, S., Caumo, W., Ciechanski, P., Charvet, L., Clark, V. P., Cohen Kadosh, R., Cotelli, Maria, Datta, A., Deng, Z. -D., De Raedt, R., De Ridder, D., Fitzgerald, P. B., Floel, A., Frohlich, F., George, M. S., Ghobadi-Azbari, P., Goerigk, S., Hamilton, R. H., Jaberzadeh, S. J., Hoy, K., Kidgell, D. J., Zonoozi, A. K., Kirton, A., Laureys, S., Lavidor, M., Lee, K., Leite, J., Lisanby, S. H., Loo, C., Martin, D. M., Miniussi, C., Mondino, M., Monte-Silva, K., Morales-Quezada, L., Nitsche, M. A., Okano, A. H., Oliveira, C. S., Onarheim, B., Pacheco-Barrios, K., Padberg, F., Nakamura-Palacios, E. M., Palm, U., Paulus, W., Plewnia, C., Priori, A., Rajji, T. K., Razza, L. B., Rehn, E. M., Ruffini, G., Schellhorn, K., Zare-Bidoky, M., Simis, M., Skorupinski, P., Suen, P., Thibaut, A., Valiengo, L. C. L., Vanderhasselt, M. -A., Vanneste, S., Venkatasubramanian, G., Violante, I. R., Wexler, A., Woods, A. J., Fregni, F., and Cotelli M.

Abstract

Objective: Although relatively costly and non-scalable, non-invasive neuromodulation interventions are treatment alternatives for neuropsychiatric disorders. The recent developments of highly-deployable transcranial electric stimulation (tES) systems, combined with mobile-Health technologies, could be incorporated in digital trials to overcome methodological barriers and increase equity of access. The study aims are to discuss the implementation of tES digital trials by performing a systematic scoping review and strategic process mapping, evaluate methodological aspects of tES digital trial designs, and provide Delphi-based recommendations for implementing digital trials using tES. Methods: We convened 61 highly-productive specialists and contacted 8 tES companies to assess 71 issues related to tES digitalization readiness, and processes, barriers, advantages, and opportunities for implementing tES digital trials. Delphi-based recommendations (>60% agreement) were provided. Results: The main strengths/opportunities of tES were: (i) non-pharmacological nature (92% of agreement), safety of these techniques (80%), affordability (88%), and potential scalability (78%). As for weaknesses/threats, we listed insufficient supervision (76%) and unclear regulatory status (69%). Many issues related to methodological biases did not reach consensus. Device appraisal showed moderate digitalization readiness, with high safety and potential for trial implementation, but low connectivity. Conclusions: Panelists recognized the potential of tES for scalability, generalizability, and leverage of digital trials processes; with no consensus about aspects regarding methodological biases. Significance: We further propose and discuss a conceptual framework for exploiting shared aspects between mobile-Health tES technologies with digital trials methodology to drive future efforts for digitizing tES trials.

Published
2022

9. Corrigendum: 'Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014–2018)' (Clinical Neurophysiology (2020) 131(2) (474–528), (S1388245719312799), (10.1016/j.clinph.2019.11.002))

Author

Lefaucheur J. -P., Aleman A., Baeken C., Benninger D. H., Brunelin J., Di Lazzaro V., Filipovic S. R., Grefkes C., Hasan A., Hummel F. C., Jaaskelainen S. K., Langguth B., Leocani L., Londero A., Nardone R., Nguyen J. -P., Nyffeler T., Oliveira-Maia A. J., Oliviero A., Padberg F., Palm U., Paulus W., Poulet E., Quartarone A., Rachid F., Rektorova I., Rossi S., Sahlsten H., Schecklmann M., Szekely D., Ziemann U., Lefaucheur, J. -P., Aleman, A., Baeken, C., Benninger, D. H., Brunelin, J., Di Lazzaro, V., Filipovic, S. R., Grefkes, C., Hasan, A., Hummel, F. C., Jaaskelainen, S. K., Langguth, B., Leocani, L., Londero, A., Nardone, R., Nguyen, J. -P., Nyffeler, T., Oliveira-Maia, A. J., Oliviero, A., Padberg, F., Palm, U., Paulus, W., Poulet, E., Quartarone, A., Rachid, F., Rektorova, I., Rossi, S., Sahlsten, H., Schecklmann, M., Szekely, D., and Ziemann, U.

Abstract

When referring to the study of Rutherford et al. (2015) on short- and long-term effects of rTMS in Alzheimer's disease, we erroneously stated in our article (Lefaucheur et al., 2020) that a clinical benefit on cognitive performance (tested by the Montreal Cognitive Assessment) was observed at weeks 2–3, only in the real stimulation condition during an initial sham-controlled 4-week period of treatment, and that then this benefit was prolonged by “2 additional weeks” of open-label real rTMS. In fact, this extended open-label treatment was administered for up to 19 months in multiple 2-week blocks with 2–7 months intervals between blocks and was not limited to a single additional 2-week block of treatment immediately following the original 4 weeks of treatment. Therefore, the results of that open-label extended follow-up study support the value of long-term maintenance treatment using multiple rTMS sessions rather than be interpreted as short-term 2-week extension.

Published
2020

13. Childhood Trauma increases suicidal behaviour in a treatment-resistant depression population: a FACE-DR report

Author

Yrondi, Antoine, primary, Vaiva, Guillaume, additional, Walter, Michel, additional, D Amato, Thierry, additional, Bellivier, Frank, additional, Bennabi, Djamila, additional, Bougerol, Thierry, additional, Camus, Vincent, additional, Doumy, Olivier, additional, Genty, Jean-Baptiste, additional, Haffen, Emmanuel, additional, Holtzmann, Jérôme, additional, Horn, Mathilde, additional, Lançon, Christophe, additional, Leboyer, Marion, additional, Llorca, Pierre-Michel, additional, Maruani, Julia, additional, Moirand, Rémi, additional, Molière, Fanny, additional, Petrucci, Jean, additional, Richieri, Raphaelle, additional, Samalin, Ludovic, additional, Schmitt, Laurent, additional, Stephan, Florian, additional, Courtet, Philippe, additional, El-Hage, Wissam, additional, Aouizerate, Bruno, additional, Aouizerate, B., additional, Bennabi, D., additional, Leboyer, M., additional, Haffen, E., additional, Llorca, P.M., additional, Barteau, V., additional, Bensalem, S., additional, Laouamri, H., additional, Souryis, Karmene, additional, Mallet, L., additional, Yon, L., additional, Petrucci, J., additional, Genty, J.B., additional, Yrondi, A., additional, Pierre, D., additional, Schmitt, L., additional, Sarrail, M., additional, Ryff, I., additional, Beuchet, E., additional, Tio, G., additional, Cappe, C., additional, Clerc, E., additional, Garnier, M., additional, Honciuc, R.M., additional, Allauze, E., additional, Blanc, O., additional, Bellivier, F., additional, Allaili, N., additional, Nieto, I., additional, Meheust, J., additional, Sunthavy, Y., additional, Maruani, J., additional, Bougerol, T., additional, Polosan, M., additional, Courvoisier, P., additional, Holtzmann, J., additional, Fredembach, B., additional, Foubert-Andreani, S., additional, Camus, V., additional, El Hage, W., additional, D’Amato, T., additional, Haesebaert, F., additional, Dubien, C., additional, Lefebvre, M., additional, Meznad, A., additional, Brunelin, J., additional, Moirand, R., additional, Doumy, O., additional, Lancon, C., additional, Richieri, R., additional, Peri, P., additional, Faugere, M., additional, Faget-Agius, C., additional, Courtet, P., additional, Boulenger, J.P., additional, Moliere, F., additional, Stephan, F., additional, Walter, M., additional, Mesmeur, C., additional, Vaiva, G., additional, and Horn, M., additional

Published
2021
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18. 3 e Conférence européenne sur la stimulation cérébrale en psychiatrie – Des mécanismes à l'application thérapeutique

Author

Brunelin, J, Mondino, M, Arns, M, Baeken, C, Brem, A-K, Filipčić, I, Ganho-Avila, A, Palm, U, Poleszczyk, A, Sauvaget, A, O'Shea, J, D'Urso, G, Poulet, E, Brein, Lichaam en Cognitie, Observerende Klinische wetenschappen, Neuroprotectie & Neuromodulatie, and Psychiatrie

Subjects
Psychiatry and Mental health, Arts and Humanities (miscellaneous)
Published
2019
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19. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS

Author

Lefaucheur, P., Antal, A., Ayache, S.s., Benninger, D.h., Brunelin, J., Cogiamanian, F., Cotelli, M., De Ridder, D., Ferrucci, R., Langguth, B., MARANGOLO, Paola, Lefaucheur, P., Antal, A., Ayache, S. s., Benninger, D. h., Brunelin, J., Cogiamanian, F., Cotelli, M., De Ridder, D., Ferrucci, R., Langguth, B., and Marangolo, Paola

Abstract

A group of European experts was commissioned by the European Chapter of the International Federation of Clinical Neurophysiology to gather knowledge about the state of the art of the therapeutic use of tran- scranial direct current stimulation (tDCS) from studies published up until September 2016, regarding pain, Parkinson’s disease, other movement disorders, motor stroke, poststroke aphasia, multiple sclerosis, epilepsy, consciousness disorders, Alzheimer’s disease, tinnitus, depression, schizophrenia, and craving. The evidence-based analysis included only studies based on repeated tDCS sessions with sham tDCS control procedure; 25 patients or more having received active treatment was required for Class I, while a lower number of 10–24 patients was accepted for Class II studies. Current evidence does not allow making any recommendation of Level A (definite efficacy) for any indication. Level B recommenda- tion (probable efficacy) is proposed for: (i) anodal tDCS of the left primary motor cortex (M1) (with right orbitofrontal cathode) in fibromyalgia; (ii) anodal tDCS of the left dorsolateral prefrontal cortex (DLPFC) (with right orbitofrontal cathode) in major depressive episode without drug resistance; (iii) anodal tDCS of the right DLPFC (with left DLPFC cathode) in addiction/craving. Level C recommendation (possible effi- cacy) is proposed for anodal tDCS of the left M1 (or contralateral to pain side, with right orbitofrontal cathode) in chronic lower limb neuropathic pain secondary to spinal cord lesion. Conversely, Level B rec- ommendation (probable inefficacy) is conferred on the absence of clinical effects of: (i) anodal tDCS of the left temporal cortex (with right orbitofrontal cathode) in tinnitus; (ii) anodal tDCS of the left DLPFC (with right orbitofrontal cathode) in drug-resistant major depressive episode. It remains to be clarified whether the probable or possible therapeutic effects of tDCS are clinically meaningful and how to optimally per- form tDCS in a therapeutic setting. In addition, the easy management and low cost of tDCS devices allow at home use by the patient, but this might raise ethical and legal concerns with regard to potential misuse or overuse. We must be careful to avoid inappropriate applications of this technique by ensuring rigorous training of the professionals and education of the patients.

Published
2017

28. Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel

Author

Fregni, F, Nitsche, M, Loo, C, Brunoni, A, Marangolo, P, Leite, J, Carvalho, S, Bolognini, N, Caumo, W, Paik, N, Simis, M, Ueda, K, Hamed, E, Luu, P, Tucker, D, Tyler, W, Brunelin, J, Datta, A, Juan, C, Venkatasubramaniam, G, Boggio, P, Bikson, M, Nitsche, MA, Brunoni, AR, Paik, NJ, Tucker, DM, Tyler, WJ, Juan, CH, Boggio, PS, Bikson, M., BOLOGNINI, NADIA, Fregni, F, Nitsche, M, Loo, C, Brunoni, A, Marangolo, P, Leite, J, Carvalho, S, Bolognini, N, Caumo, W, Paik, N, Simis, M, Ueda, K, Hamed, E, Luu, P, Tucker, D, Tyler, W, Brunelin, J, Datta, A, Juan, C, Venkatasubramaniam, G, Boggio, P, Bikson, M, Nitsche, MA, Brunoni, AR, Paik, NJ, Tucker, DM, Tyler, WJ, Juan, CH, Boggio, PS, Bikson, M., and BOLOGNINI, NADIA

Abstract

The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. Therefore, a group of research and clinician experts on tDCS were convened to review the research and clinical use of tDCS. This report reviews the regulatory status of tDCS and summarizes the results according to research, off-label, and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan, and the US. Research use, off label treatment, and compassionate use of tDCS are employed in most of the countries reviewed in this study. It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials.

Published
2015

31. TREATMENT OF SHIZOPHRENIC PATIENTS AND rTMS

Author

Poulet E, Haesebaert F, Mohamed Saoud, Mf, Suaud-Chagny, and Brunelin J

Subjects
Parietal Lobe, Schizophrenia, Humans, Schizophrenic Psychology, Dominance, Cerebral, Transcranial Magnetic Stimulation, rTMS, auditory hallucinations, negative symptoms, schizophrenia, Temporal Lobe, Follow-Up Studies
Abstract

Introduction: Schizophrenia (SCH) is a heterogeneous syndrome characterized by positive and negative symptoms. Despite appropriate medication, about 1/4 of patients suffer for refractory positive and/or negative symptoms, which are associated with functional handicap, increase of duration and of the number of hospitalizations. Numerous studies have suggested that the pathophysiology of auditory hallucinations (AH) is related to a hyper activity of the left temporoparietal cortex (TPC). On the other hand, negative symptoms are associated with a prefrontal hypoactivity and the efficiency of pharmacological treatments is frequently partial. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation tool with excellent tolerability and safety. Given its hypothesized mechanisms of action and the clinical beneficial effects obtained in several types of pathology (Aleman et al. 2007), the efficacy of rTMS has been investigated for drug-resistant SCH symptoms. Objective: Our objective is to expose the knowledge concerning the rTMS use in the treatment of these symptoms and to purpose a critical analysis of these data. Method: a systematic review of the literature has been conducted using NIH Pubmed. The following search terms were used: TMS - rTMS - Schizophrenia - negative symptoms - hallucinations. Results: Concerning the treatment of AH, 16 publications and 4 meta analyses were selected. For the negative symptoms, we retained 16 studies and 3 meta analyses. The most extensively investigated application for rTMS in SCH is the use of low-frequency stimulation to the left TPC with the aim to improve AH symptomatology. When compared to sham, this type of acute course of rTMS has been proven to induce a substantial and significant reduction in AH. But this effect does not seem long-lasting and maintenance protocols must be developed. Concerning negative symptoms, the results are less solid but we find some works which demonstrate an improvement of these symptoms while various stimulation parameters were used. Recently, new parameters of stimulation in particular the theta burst stimulation have permitted us to obtain larger effects with longer duration. The interest of these new parameters will be discussed here. Conclusion: Overall, rTMS studies have demonstrated some promise in the treatment of SCH. However, more research is required to enhance rTMS efficacy and increase its beneficial effect duration and to test new therapeutic strategies in this topic.

Published
2010

32. Regulatory considerations for the clinical and research use of transcranial direct current stimulation (tDCS): Review and recommendations from an expert panel

Author

Fregni, F., primary, Nitsche, M. A., additional, Loo, C. K., additional, Brunoni, A. R., additional, Marangolo, P., additional, Leite, J., additional, Carvalho, S., additional, Bolognini, N., additional, Caumo, W., additional, Paik, N. J., additional, Simis, M., additional, Ueda, K., additional, Ekhtiari, H., additional, Luu, P., additional, Tucker, D. M., additional, Tyler, W. J., additional, Brunelin, J., additional, Datta, A., additional, Juan, C. H., additional, Venkatasubramanian, G., additional, Boggio, P. S., additional, and Bikson, M., additional

Published
2014
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44. Regulatory considerations for the clinical and research use of transcranial direct current stimulation (tDCS): Review and recommendations from an expert panel.

Author

Fregni, F., Nitsche, M. A., Loo, C. K., Brunoni, A. R., Marangolo, P., Leite, J., Carvalho, S., Bolognini, N., Caumo, W., Paik, N. J., Simis, M., Ueda, K., Ekhtiari, H., Luu, P., Tucker, D. M., Tyler, W. J., Brunelin, J., Datta, A., Juan, C. H., and Venkatasubramanian, G.

Subjects
TRANSCRANIAL direct current stimulation, CLINICAL trials, MEDICAL research, NEUROSCIENCES
Abstract

The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. Therefore, a group of research and clinician experts on tDCS were convened to review the research and clinical use of tDCS. This report reviews the regulatory status of tDCS and summarizes the results according to research, off-label, and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan, and the US. Research use, off label treatment, and compassionate use of tDCS are employed in most of the countries reviewed in this study. It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials. [ABSTRACT FROM AUTHOR]

Published
2015
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47. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia.

Author

Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, and Poulet E

Abstract

OBJECTIVE: Some 25%-30% of patients with schizophrenia have auditory verbal hallucinations that are refractory to antipsychotic drugs. Outcomes in studies of repetitive transcranial magnetic stimulation suggest the possibility that application of transcranial direct-current stimulation (tDCS) with inhibitory stimulation over the left temporo-parietal cortex and excitatory stimulation over the left dorsolateral prefrontal cortex could affect hallucinations and negative symptoms, respectively. The authors investigated the efficacy of tDCS in reducing the severity of auditory verbal hallucinations as well as negative symptoms. METHOD: Thirty patients with schizophrenia and medication-refractory auditory verbal hallucinations were randomly allocated to receive 20 minutes of active 2-mA tDCS or sham stimulation twice a day on 5 consecutive weekdays. The anode was placed over the left dorsolateral prefrontal cortex and the cathode over the left temporo-parietal cortex. RESULTS: Auditory verbal hallucinations were robustly reduced by tDCS relative to sham stimulation, with a mean diminution of 31% (SD=14; d=1.58, 95% CI=0.76-2.40). The beneficial effect on hallucinations lasted for up to 3 months. The authors also observed an amelioration with tDCS of other symptoms as measured by the Positive and Negative Syndrome Scale (d=0.98, 95% CI=0.22-1.73), especially for the negative and positive dimensions. No effect was observed on the dimensions of disorganization or grandiosity/excitement. CONCLUSIONS: Although this study is limited by the small sample size, the results show promise for treating refractory auditory verbal hallucinations and other selected manifestations of schizophrenia. [ABSTRACT FROM AUTHOR]

Published
2012
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48. Effects of acute metabolic stress on the dopaminergic and pituitary-adrenal axis activity in patients with schizophrenia, their unaffected siblings and controls.

Author

Brunelin J, d'Amato T, van Os J, Cochet A, Suaud-Chagny MF, Saoud M, Brunelin, Jerome, d'Amato, Thierry, van Os, Jim, Cochet, Alain, Suaud-Chagny, Marie-Françoise, and Saoud, Mohamed

Abstract

A genetically mediated abnormal sensitivity to stress is thought to play a role in the onset, exacerbation and relapse of schizophrenia. In a double blind, placebo-controlled crossover study, peak increases in plasma ACTH (Delta ACTH) and homovanillic-acid, a dopamine metabolite, (Delta HVA) following exposure to a metabolic stressor(2DG) were studied in unaffected siblings of patients with schizophrenia (n=15), their patient relatives (n=15) and healthy controls (n=14). Siblings showed a stress response (both Delta ACTH and Delta HVA) that was significantly greater compared to controls and significantly less pronounced compared to patients. The results suggest that the genetic risk for schizophrenia may be characterized by an enhanced sensitivity to stress. [ABSTRACT FROM AUTHOR]

Published
2008
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