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3. Real Time Video Projection in an MRI for the Characterization of the Neural Correlates Associated with Mirror Therapy treatment for Phantom Limb Pain

Author

Saleh Velez, FG, Pinto, CB, Bailin, ES, Münger, M, Ellison, A, Costa, BT, Crandell, D, Bolognini, N, Merabet, LB, Fregni, F., Saleh Velez, F, Pinto, C, Bailin, E, Münger, M, Ellison, A, Costa, B, Crandell, D, Bolognini, N, Merabet, L, and Fregni, F

Subjects
Phantom limb pain, fMRI, brain imaging, mirror therapy, amputation, neuroplasticity, sensorimotor cortex
Abstract

Mirror therapy (MT) has been proposed as an effective rehabilitative strategy to alleviate pain symptoms in amputees with phantom limb pain (PLP). However, establishing the neural correlates associated with MT therapy have been challenging given that it is difficult to administer the therapy effectively within a magnetic resonance imaging (MRI) scanner environment. To characterize the functional organization of cortical regions associated with this rehabilitative strategy, we have developed a combined behavioral and functional neuroimaging protocol that can be applied in participants with a leg amputation. This novel approach allows participants to undergo MT within the MRI scanner environment by viewing real-time video images captured by a camera. The images are viewed by the participant through a system of mirrors and a monitor that the participant views while lying on the scanner bed. In this manner, functional changes in cortical areas of interest (e.g., sensorimotor cortex) can be characterized in response to the direct application of MT.

Published
2019

5. Strategies to Enhance Recruitment Methods in Phantom Limb Pain Clinical Trials

Author

Pinto, C, Vélez, F, French, M, Zeng, D, Crandell, D, Bolognini, N, Merabet, L, Fregni, F, Pinto CB, Vélez FGS, French MN, Zeng D, Crandell D, Bolognini N, Merabet LB, Fregni F., Pinto, C, Vélez, F, French, M, Zeng, D, Crandell, D, Bolognini, N, Merabet, L, Fregni, F, Pinto CB, Vélez FGS, French MN, Zeng D, Crandell D, Bolognini N, Merabet LB, and Fregni F.

Published
2017

6. Real Time Video Projection in an MRI for the Characterization of the Neural Correlates Associated with Mirror Therapy treatment for Phantom Limb Pain.

Author

Saleh Velez, F, Pinto, C, Bailin, E, Münger, M, Ellison, A, Costa, B, Crandell, D, Bolognini, N, Merabet, L, Fregni, F, Saleh Velez, FG, Pinto, CB, Bailin, ES, Costa, BT, Merabet, LB, Fregni, F., Saleh Velez, F, Pinto, C, Bailin, E, Münger, M, Ellison, A, Costa, B, Crandell, D, Bolognini, N, Merabet, L, Fregni, F, Saleh Velez, FG, Pinto, CB, Bailin, ES, Costa, BT, Merabet, LB, and Fregni, F.

Abstract

Mirror therapy (MT) has been proposed as an effective rehabilitative strategy to alleviate pain symptoms in amputees with phantom limb pain (PLP). However, establishing the neural correlates associated with MT therapy have been challenging given that it is difficult to administer the therapy effectively within a magnetic resonance imaging (MRI) scanner environment. To characterize the functional organization of cortical regions associated with this rehabilitative strategy, we have developed a combined behavioral and functional neuroimaging protocol that can be applied in participants with a leg amputation. This novel approach allows participants to undergo MT within the MRI scanner environment by viewing real-time video images captured by a camera. The images are viewed by the participant through a system of mirrors and a monitor that the participant views while lying on the scanner bed. In this manner, functional changes in cortical areas of interest (e.g., sensorimotor cortex) can be characterized in response to the direct application of MT.

Published
2019

7. Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation: A Randomized, Double–Blind Clinical Trial Study Protocol.

Author

Pinto, C, Saleh Velez, F, Bolognini, N, Crandell, D, Merabet, L, Fregni, F, Pinto, CB, Saleh Velez, FG, BOLOGNINI, NADIA, Merabet, LB, Fregni, F., Pinto, C, Saleh Velez, F, Bolognini, N, Crandell, D, Merabet, L, Fregni, F, Pinto, CB, Saleh Velez, FG, BOLOGNINI, NADIA, Merabet, LB, and Fregni, F.

Abstract

BACKGROUND: Despite the multiple available pharmacological and behavioral therapies for the management of chronic phantom limb pain (PLP) in lower limb amputees, treatment for this condition is still a major challenge and the results are mixed. Given that PLP is associated with maladaptive brain plasticity, interventions that promote cortical reorganization such as non-invasive brain stimulation and behavioral methods including transcranial direct current stimulation (tDCS) and mirror therapy (MT), respectively, may prove to be beneficial to control pain in PLP. Due to its complementary effects, a combination of tDCS and MT may result in synergistic effects in PLP. OBJECTIVE: The objective of this study is to evaluate the efficacy of tDCS and MT as a rehabilitative tool for the management of PLP in unilateral lower limb amputees. METHODS: A prospective, randomized, placebo-controlled, double-blind, factorial, superiority clinical trial will be carried out. Participants will be eligible if they meet the following inclusion criteria: lower limb unilateral traumatic amputees that present PLP for at least 3 months after the amputated limb has completely healed. Participants (N=132) will be randomly allocated to the following groups: (1) active tDCS and active MT, (2) sham tDCS and active MT, (3) active tDCS and sham MT, and (4) sham tDCS and sham MT. tDCS will be applied with the anodal electrode placed over the primary motor cortex (M1) contralateral to the amputation side and the cathode over the contralateral supraorbital area. Stimulation will be applied at the same time of the MT protocol with the parameters 2 mA for 20 minutes. Pain outcome assessments will be performed at baseline, before and after each intervention session, at the end of MT, and in 2 follow-up visits. In order to assess cortical reorganization and correlate with clinical outcomes, participants will undergo functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS) b

Published
2016

9. Best Practice Guidelines on Surgical Response in Disasters and Humanitarian Emergencies: Report of the 2011 Humanitarian Action Summit Working Group on Surgical Issues within the Humanitarian Space

Author

Chackungal, S. (author), Nickerson, J.W. (author), Knowlton, L.M. (author), Black, L. (author), Burkle Jr., F.M. (author), Casey, K. (author), Crandell, D. (author), Demey, D. (author), di Giacomo, L. (author), Dohlman, L. (author), Goldstein, J. (author), Gosney Jr., J.E. (author), Ikeda, K. (author), Linden, A. (author), Mullaly, C.M. (author), O'Connell, C. (author), Redmond, A.D. (author), Richards, A. (author), Rufsvold, R. (author), Rodrigues Santos, A.L. (author), Skelton, T. (author), McQueen, K. (author), Chackungal, S. (author), Nickerson, J.W. (author), Knowlton, L.M. (author), Black, L. (author), Burkle Jr., F.M. (author), Casey, K. (author), Crandell, D. (author), Demey, D. (author), di Giacomo, L. (author), Dohlman, L. (author), Goldstein, J. (author), Gosney Jr., J.E. (author), Ikeda, K. (author), Linden, A. (author), Mullaly, C.M. (author), O'Connell, C. (author), Redmond, A.D. (author), Richards, A. (author), Rufsvold, R. (author), Rodrigues Santos, A.L. (author), Skelton, T. (author), and McQueen, K. (author)

Abstract

The provision of surgery within humanitarian crises is complex, requiring coordination and cooperation among all stakeholders. During the 2011 Humanitarian Action Summit best practice guidelines were proposed to provide greater accountability and standardization in surgical humanitarian relief efforts. Surgical humanitarian relief planning should occur early and include team selection and preparation, appropriate disaster-specific anticipatory planning, needs assessment, and an awareness of local resources and limitations of cross-cultural project management. Accurate medical record keeping and timely follow-up is important for a transient surgical population. Integration with local health systems is essential and will help facilitate longer term surgical health system strengthening., Design Engineering, Industrial Design Engineering

Published
2011

12. The comatose patient.

Author

CRANDELL, D. LEROY, PAGE, WILLIAM G., CRANDELL, D L, and PAGE, W G

Published
1958

14. Unexpectedly wide rf-induced synchrotron sideband depolarizing resonances

Author

Chu, C. M., primary, Ellison, T. J. P., additional, Lee, S. Y., additional, Rinckel, T., additional, Schwandt, P., additional, Sperisen, F., additional, von Przewoski, B., additional, Anferov, V. A., additional, Blinov, B. B., additional, Bychkov, M. A., additional, Caussyn, D. D., additional, Courant, E. D., additional, Crandell, D. A., additional, Derbenev, Ya. S., additional, Kaufman, W. A., additional, Krisch, A. D., additional, Lorenzon, W., additional, Nurushev, T. S., additional, Phelps, R. A., additional, Ratner, L. G., additional, Wong, V. K., additional, Ohmori, C., additional, Minty, M. G., additional, Martin, P. S., additional, Russell, A. D., additional, and Sivers, D. W., additional

Published
1998
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15. First Observation of a Snake Depolarizing Resonance

Author

Phelps, R. A., primary, Anferov, V. A., additional, Blinov, B. B., additional, Crandell, D. A., additional, Koutin, S. V., additional, Krisch, A. D., additional, Liu, T. J., additional, Ratner, L. G., additional, Wong, V. K., additional, Chu, C. M., additional, Lee, S. Y., additional, Rinckel, T., additional, Schwandt, P., additional, Sperisen, F., additional, Stephenson, E. J., additional, von Przewoski, B., additional, and Sato, H., additional

Published
1997
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16. Spin Flipping through an Intrinsic Depolarizing Resonance by Strengthening It

Author

Crandell, D. A., primary, Anferov, V. A., additional, Blinov, B. B., additional, Caussyn, D. D., additional, Derbenev, Ya. S., additional, Hu, S -Q., additional, Koutin, S. V., additional, Krisch, A. D., additional, Liu, T. J., additional, Phelps, R. A., additional, Ratner, L. G., additional, Wong, V. K., additional, Chu, C. M., additional, Lee, S. Y., additional, Rinckel, T., additional, Schwandt, P., additional, Sperisen, F., additional, Stephenson, E. J., additional, von Przewoski, B., additional, and Berglund, M., additional

Published
1996
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17. Crossing Intrinsic Depolarizing Resonances by Varying a Partial Siberian Snake

Author

Alexeeva, L. V., primary, Anferov, V. A., additional, Crandell, D. A., additional, Hu, S-Q., additional, Krisch, A. D., additional, Phelps, R. A., additional, Ratner, L. G., additional, Varzar, S. M., additional, Wong, V. K., additional, Lee, S. Y., additional, Rinckel, T., additional, Schwandt, P., additional, Sperisen, F., additional, Stephenson, E. J., additional, von Przewoski, B., additional, Baiod, R., additional, Martin, P. S., additional, Russell, A. D., additional, Sato, H., additional, and Minty, M. G., additional

Published
1996
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18. Observation of a Second-Order Spin-Depolarizing Resonance

Author

Ohmori, C., primary, Sato, H., additional, Alexeeva, L. V., additional, Anferov, V. A., additional, Caussyn, D. D., additional, Chu, C. M., additional, Crandell, D. A., additional, Gladycheva, S. E., additional, Hu, S-Q., additional, Krisch, A. D., additional, Phelps, R. A., additional, Varzar, S. M., additional, Wong, V. K., additional, Lee, S. Y., additional, Rinckel, T., additional, Schwandt, P., additional, Sperisen, F., additional, Stephenson, E. J., additional, von Przewoski, B., additional, Baiod, R., additional, and Russell, A. D., additional

Published
1995
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19. First test of a partial Siberian snake for acceleration of polarized protons

Author

Caussyn, D. D., primary, Baiod, R., additional, Blinov, B. B., additional, Chu, C. M., additional, Courant, E. D., additional, Crandell, D. A., additional, Derbenev, Ya. S., additional, Ellison, T. J. P., additional, Kaufman, W. A., additional, Krisch, A. D., additional, Lee, S. Y., additional, Minty, M. G., additional, Nurushev, T. S., additional, Ohmori, C., additional, Phelps, R. A., additional, Raczkowski, D. B., additional, Ratner, L. G., additional, Schwandt, P., additional, Stephenson, E. J., additional, Sperisen, F., additional, Przewoski, B. von, additional, Wienands, U., additional, and Wong, V. K., additional

Published
1995
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20. Spin flipping a stored vertically polarized proton beam with an RF solenoid

Author

Phelps, R. A., primary, Blinov, B. B., additional, Chu, C. M., additional, Courant, E. D., additional, Crandell, D. A., additional, Kaufman, W. A., additional, Krisch, A. D., additional, Nurushev, T. S., additional, Ratner, L. G., additional, Wong, V. K., additional, Caussyn, D. D., additional, Derbenev, Ya. S., additional, Ellison, T. J. P., additional, Lee, S. Y., additional, Rinckel, T., additional, Schwandt, P., additional, Sperisen, F., additional, Stephenson, E. J., additional, Przewoski, B. von, additional, and Ohmori, C., additional

Published
1995
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21. Spin Flipping a Stored Polarized Proton Beam

Author

Caussyn, D. D., primary, Derbenev, Ya. S., additional, Ellison, T. J. P., additional, Lee, S. Y., additional, Rinckel, T., additional, Schwandt, P., additional, Sperisen, F., additional, Stephenson, E. J., additional, von Przewoski, B., additional, Blinov, B. B., additional, Chu, C. M., additional, Courant, E. D., additional, Crandell, D. A., additional, Kaufman, W. A., additional, Krisch, A. D., additional, Nurushev, T. S., additional, Phelps, R. A., additional, Ratner, L. G., additional, Wong, V. K., additional, and Ohmori, C., additional

Published
1994
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22. First Test of a Partial Siberian Snake During Polarized Beam Acceleration

Author

Blinov, B. B., primary, Chu, C. M., additional, Courant, E. D., additional, Crandell, D. A., additional, Kaufman, W. A., additional, Krisch, A. D., additional, Nurushev, T. S., additional, Phelps, R. A., additional, Raczkowski, D. B., additional, Ratner, L. G., additional, Wong, V. K., additional, Caussyn, D. D., additional, Derbenev, Ya. S., additional, Ellison, T. J. P., additional, Lee, S. Y., additional, Rinckel, T., additional, Schwandt, P., additional, Sperisen, F., additional, Stephenson, E. J., additional, von Przewoski, B., additional, Baiod, R., additional, Minty, M. G., additional, Ohmori, C., additional, and Wienands, U., additional

Published
1994
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23. Adiabatic partial Siberian snake turn-on with no beam depolarization

Author

Phelps, R. A., primary, Anferov, V. A., additional, Chu, C. M., additional, Courant, E. D., additional, Crandell, D. A., additional, Derbenev, Ya. S., additional, Kaufman, W. A., additional, Koulsha, A. V., additional, Krisch, A. D., additional, Nurushev, T. S., additional, Raczkowksi, D. B., additional, Sund, S. E., additional, Wong, V. K., additional, Caussyn, D. D., additional, Ellison, T. J. P., additional, Lee, S. Y., additional, Sperisen, F., additional, Stephenson, E. J., additional, von Przewoski, B., additional, Baiod, R., additional, Khiari, F. Z., additional, Ratner, L. G., additional, and Sato, H., additional

Published
1994
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24. A revolution in the employment process of individuals with disabilities: customized employment as the catalyst for system change.

Author

Citron T, Brooks-Lane N, Crandell D, Brady K, Cooper M, and Revell G

Abstract

The purpose of this paper is to describe and analyze a seven-year systems change effort focused on developing customized employment opportunities through a community rehabilitation program (CRP) that provides supports to persons with mental illness, developmental disabilities, and addictive diseases in Georgia. By using case studies and qualitative data, the path to real and effective organizational improvement in the area of customized employment outcomes is explored. Seven points of analysis on systematic organizational development emerged from the data review: (1) staff development; (2) community partnerships and diversified funding; (3) sustainability; (4) shift in managerial approaches and supervision; (5) changes in human resource processes; and (6) expanding customized employment to diverse populations; i.e. offenders, youth, welfare to work. This examination illustrates the need for: best practice staff training, person-centered and community-based vocational assessments, customer-directed personal budgets, flexible funding, focus on evidence-based customized employment outcomes as performance indicators, values-based human resource processes, CRP executive leadership involvement with staff and customers to break down barriers and achieve organizational momentum for outcome-driven change. Case studies for individuals who achieved customized employment outcomes are provided. [ABSTRACT FROM AUTHOR]

Published
2008

26. The Anesthetic Hazards in Patients on Antihypertensive Therapy

Author

Crandell, D. LeRoy

Abstract

Antihypertensive drugs interfere with hemodynamic adjustments and can cause profound cardiovascular collapse when a patient is subjected to the stress of anesthesia and surgery. They constitute an insidious hazard to surgical patients. In patients who have received antihypertensive medication the primary problem is to determine the availability of the intrinsic catechol amines and the patient's ability to respond to them. This problem is solved by using the ephedrine response test (ERT). The test consists of 2 intravenous injections of ephedrine; the first injection of 10 mg. is followed promptly by additional 5 mg. If the ERT does not elicit a rise of at least 20 mm. Hg in blood pressure, the patient is believed to be unprepared for the cardiovascular stress of general, spinal, or spidural anesthesia.

Published
1962
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27. Pheochromocytoma—Anesthetic and Surgical Considerations

Author

Crandell, D. LeRoy and Myers, Richard T.

Abstract

Eleven consecutive cases of pheochromocytoma were successfully diagnosed and surgically cured. The rational anesthetic management of a patient with pheochromocytoma should be based on a firm foundation of applied pharmacology. Cardiovascular control is best maintained symptomatically using phentolamine (Regitine) hydrochloride to control excessive hypertension, and with appropriate vasopressors, whole blood or plasma and possible cortisone acetate, to combat hypotension after the tumor is removed. The advantages associated with the transabdominal surgical approach are stressed. The patient with pheochromocytoma can tolerate anesthesia and the associated surgical procedure well through the combined efforts of the anesthesiologist and surgeon in executing their specific responsibilities.

Published
1964
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28. CONTROL OF NEUROMUSCULAR MANIFESTATIONS OF SEVERE SYSTEMIC TETANUS

Author

Crandell, D. LeRoy and Whitcher, Charles E.

Abstract

To arrest the progress of tetanus in a patient two main objectives must be attained, namely, the neutralization of circulating toxin and the elimination of its source. Meanwhile the neuromuscular manifestations must be controlled. Drugs used for this purpose are generally depressants of the central nervous system. If they hamper cardiovascular and respiratory function their use is illogical. The regimen advised by the authors employs a sedative (either secobarbital or pentobarbital) and a muscle relaxant (methocarbamol) together with chlorpromazine, which is believed to potentiate the sedative-relaxant effects of the other two drugs. Strict attention to pulmonary ventilation is essential. Tracheotomy should be performed early in severe cases. The aspiration of tracheobronchial secretions must be prevented, and it may be necessary to assist respiration by mechanical means. In the prevention of asphyxia the anesthesiologist can play a vital role.

Published
1960
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29. Therapy for Hypotension Induced by Spinal Anesthesia During Pregnancy: Observations on Gravid Ewes

Author

Greiss, Frank C. and Crandell, D. LeRoy

Abstract

During actual and simulated spinal anesthesia in 21 term gravid ewes, induced maternal hypotension was associated with a proportionate decrease in uterine blood flow (UBF). Under these circumstances, vasopressor drugs administered intravenously restored maternal blood pressure (MBP) to normal without improving uterine blood flow. However, rapid infusions of 5% dextrose or dextran solution significantly improved both MBP and UBF proportionately. These results indicate that the prophylactic or therapeutic use of vasopressor agents in conjunction with spinal or caudal anesthesia during pregnancy is contraindicated. Rather, therapy designed to increase effective circulating blood volume should be initiated. This includes a rapid intravenous infusion of dextrose solution, elevation of the legs, and displacement of the uterus to the left to reduce vena caval obstruction and increase venous return to the heart.

Published
1965
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30. Neuroleptanalgesia for Heart and Major Surgery

Author

FOX, JOHN W. C., FOX, ELISABETH J., and CRANDELL, D. LeROY

Abstract

NEUROLEPTANALGESIA is based upon the use of a tranquilizer and a narcotic administered intravenously to produce a state of psychic withdrawal and profound analgesia.1 Several series of tranquilizers and narcotics have been investigated in Europe; those currently available for investigation in the United States, droperidol2 and fentanyl citrate,3 represent the most evolved of these so far.Droperidol, a butyrophenone, is a potent tranquilizer which produces in the patient a state of calm, disinclination to move, and "disconnection" from the surroundings. It has an α-adrenergic blocking effect, which offers some protection against shock, leads to good peripheral perfusion, and "unmasks" hypovolemia. It also protects against epinephrine-induced arrhythmias, and has an antiemetic effect.Droperidol may cause hypotension by virtue of its α-adrenergic blocking effect and peripheral vasodilatation, particularly when the drug is administered rapidly and in the presence of hypovolemia. The hypotension is usually transitory in the former case,

Published
1967
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45. STRATEGIES TO ENHANCE RECRUITMENT METHODS IN PHANTOM LIMB PAIN CLINICAL TRIALS

Author

Camila Bonin Pinto, Melanie French, Felipe Fregni, David Crandell, Faddi Ghassan Saleh Velez, Nadia Bolognini, Lotfi B. Merabet, Dian Zeng, Pinto, C, Vélez, F, French, M, Zeng, D, Crandell, D, Bolognini, N, Merabet, L, and Fregni, F

Subjects
medicine.medical_specialty, business.industry, Psychological intervention, MEDLINE, Alternative medicine, Phantom limb pain, Article, law.invention, Clinical trial, 03 medical and health sciences, phantom limb pain, randomized clinical trials, 0302 clinical medicine, Physical medicine and rehabilitation, Randomized controlled trial, law, medicine, Physical therapy, Generalizability theory, 030212 general & internal medicine, Recruitment methods, business, 030217 neurology & neurosurgery
Abstract

Phantom limp pain (PLP) was first described in 1551. To date, its mechanisms and novel interventions remain mostly untested. Only limited conclusions can be drawn from few and small sized randomized clinical trials (RCTs) on PLP. In this scenario, enhanced recruitment strategies are crucial in order to overcome inherent challenges to recruit and enroll PLP subjects for clinical trials. Although there are many general methods to enhance recruitment and also retention, in this article we discuss these methods based on a common topic; dissemination. We summarize and discuss ten strategies of recruitment related to the dissemination of information based on the notion that increased trial awareness may lead to both improved recruitment and also external generalizability. In addition, we include insights based on our experience recruiting PLP patients for the purposes of a large-scale and on-going NIH-sponsored clinical trial. Although specific regulatory considerations need to be considered when choosing the methods of recruitment (which may vary across different countries and Institutional Review Boards (IRBs)), these strategies may be applicable to most research settings.

Published
2017

46. Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation: A Randomized, Double–Blind Clinical Trial Study Protocol

Author

Lotfi B. Merabet, Nadia Bolognini, Felipe Fregni, David Crandell, Faddi Ghassan Saleh Velez, Camila Bonin Pinto, Pinto, C, Saleh Velez, F, Bolognini, N, Crandell, D, Merabet, L, and Fregni, F

Subjects
medicine.medical_specialty, non-invasive brain stimulation, medicine.medical_treatment, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, medicine, Protocol, 030212 general & internal medicine, 10. No inequality, electrical stimulation, electric stimulation therapy, tDCS, phantom limb pain, Rehabilitation, Transcranial direct-current stimulation, transcranial electrical stimulation, clinical trial, mirror therapy, General Medicine, Institutional review board, 3. Good health, Clinical trial, Transcranial magnetic stimulation, Amputation, Brain stimulation, factorial design, Physical therapy, cerebral cortex, Psychology, 030217 neurology & neurosurgery
Abstract

Background: Despite the multiple available pharmacological and behavioral therapies for the management of chronic phantom limb pain (PLP) in lower limb amputees, treatment for this condition is still a major challenge and the results are mixed. Given that PLP is associated with maladaptive brain plasticity, interventions that promote cortical reorganization such as non-invasive brain stimulation and behavioral methods including transcranial direct current stimulation (tDCS) and mirror therapy (MT), respectively, may prove to be beneficial to control pain in PLP. Due to its complementary effects, a combination of tDCS and MT may result in synergistic effects in PLP. Objective: The objective of this study is to evaluate the efficacy of tDCS and MT as a rehabilitative tool for the management of PLP in unilateral lower limb amputees. Methods: A prospective, randomized, placebo-controlled, double-blind, factorial, superiority clinical trial will be carried out. Participants will be eligible if they meet the following inclusion criteria: lower limb unilateral traumatic amputees that present PLP for at least 3 months after the amputated limb has completely healed. Participants (N=132) will be randomly allocated to the following groups: (1) active tDCS and active MT, (2) sham tDCS and active MT, (3) active tDCS and sham MT, and (4) sham tDCS and sham MT. tDCS will be applied with the anodal electrode placed over the primary motor cortex (M1) contralateral to the amputation side and the cathode over the contralateral supraorbital area. Stimulation will be applied at the same time of the MT protocol with the parameters 2 mA for 20 minutes. Pain outcome assessments will be performed at baseline, before and after each intervention session, at the end of MT, and in 2 follow-up visits. In order to assess cortical reorganization and correlate with clinical outcomes, participants will undergo functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS) before and after the intervention. Results: This clinical trial received institutional review board (IRB) approval in July of 2015 and enrollment started in December of 2015. To date 2 participants have been enrolled. The estimate enrollment rate is about 30 to 35 patients per year; thus we expect to complete enrollment in 4 years. Conclusions: This factorial design will provide relevant data to evaluate whether tDCS combined with MT is more effective than each therapy alone, as well as with no intervention (sham/sham) in patients with chronic PLP after unilateral lower limb amputation. In addition, this randomized clinical trial will help to investigate the neurophysiological mechanisms underlying the disease, which could potentially provide relevant findings for further management of this chronic condition and also help to optimize the use of this novel intervention. Trial Registration: Clinicaltrials.gov NCT02487966; https://clinicaltrials.gov/ct2/show/NCT02487966 (Archived by WebCite at http://www.webcitation.org/6i3GrKMyf)

Published
2016

48. Using Home-based, Remotely Supervised, Transcranial Direct Current Stimulation for Phantom Limb Pain.

Author

Pacheco-Barrios K, Martinez-Magallanes D, Naqui CX, Daibes M, Pichardo E, Cardenas-Rojas A, Crandell D, Dua A, Datta A, Caumo W, and Fregni F

Subjects
Humans, Brain, Transcranial Direct Current Stimulation methods, Phantom Limb therapy
Abstract

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that uses low-amplitude direct currents to alter cortical excitability. Previous trials have established the safety and tolerability of tDCS, and its potential to mitigate symptoms. However, the effects are cumulative, making it more difficult to have adherence to the treatment since frequent visits to the clinic or outpatient center are required. Moreover, the time needed for transportation to the center and the related expenses limit the accessibility of the treatment for many participants. Following guidelines for remotely supervised transcranial direct current stimulation (RS-tDCS) implementation, we propose a protocol designed for remotely supervised and home-based participation that uses specific devices and materials modified for patient use, with real-time monitoring by researchers through an encrypted video conferencing platform. We have developed detailed instructional materials and structured training procedures to allow for self- or proxy-administration while supervised remotely in real time. This protocol has a specific design to have a series of checkpoints during training and execution of the visit. This protocol is currently in use in a large pragmatic study of RS-tDCS for phantom limb pain (PLP). In this article, we will discuss the operational challenges of conducting a home-based RS-tDCS session and show methods to enhance its efficacy with supervised sessions.

Published
2024
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50. Effects of Combined and Alone Transcranial Motor Cortex Stimulation and Mirror Therapy in Phantom Limb Pain: A Randomized Factorial Trial.

Author

Gunduz ME, Pacheco-Barrios K, Bonin Pinto C, Duarte D, Vélez FGS, Gianlorenco ACL, Teixeira PEP, Giannoni-Luza S, Crandell D, Battistella LR, Simis M, and Fregni F

Subjects
Adult, Combined Modality Therapy, Double-Blind Method, Evoked Potentials, Motor physiology, Female, Humans, Male, Middle Aged, Phantom Limb physiopathology, Treatment Outcome, Young Adult, Mirror Movement Therapy methods, Motor Cortex physiopathology, Phantom Limb therapy, Transcranial Magnetic Stimulation methods
Abstract

Phantom limb pain (PLP) is a frequent complication in amputees, which is often refractory to treatments. We aim to assess in a factorial trial the effects of transcranial direct current stimulation (tDCS) and mirror therapy (MT) in patients with traumatic lower limb amputation; and whether the motor cortex plasticity changes drive these results. In this large randomized, blinded, 2-site, sham-controlled, 2 × 2 factorial trial, 112 participants with traumatic lower limb amputation were randomized into treatment groups. The interventions were active or covered MT for 4 weeks (20 sessions, 15 minutes each) combined with 2 weeks of either active or sham tDCS (10 sessions, 20 minutes each) applied to the contralateral primary motor cortex. The primary outcome was PLP changes on the visual analogue scale at the end of interventions (4 weeks). Motor cortex excitability and cortical mapping were assessed by transcranial magnetic stimulation (TMS). We found no interaction between tDCS and MT groups ( F = 1.90, P = .13). In the adjusted models, there was a main effect of active tDCS compared to sham tDCS (beta coefficient = -0.99, P = .04) on phantom pain. The overall effect size was 1.19 (95% confidence interval: 0.90, 1.47). No changes in depression and anxiety were found. TDCS intervention was associated with increased intracortical inhibition (coefficient = 0.96, P = .02) and facilitation (coefficient = 2.03, P = .03) as well as a posterolateral shift of the center of gravity in the affected hemisphere. MT induced no motor cortex plasticity changes assessed by TMS. These findings indicate that transcranial motor cortex stimulation might be an affordable and beneficial PLP treatment modality.

Published
2021
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