The effects of individually tailored rTMS on hand function in chronic stroke: a protocol for an adaptive, phase II, randomized, sham-controlled clinical trial
Stroke is a leading cause of disability among adults. Existing rehabilitation programs haven’t been able to accomplish full motor recovery partially due to the pathologic plasticity exerted from the unaffected hemisphere to the affected one. This inhibition can be disrupted using non-invasive brain...
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2016
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| author | Jannati, Ali PEP, Teixeira Santoro‐Lopes, Guilherme Babiker-Mohamed, Mohamed Huerta, Rodrigo LB, Filier Haseeb, Abdul Nakashima, Akio Chan, Amy Garcia Rodrigues, Andre Cervantes Andino, Andres León‐Justel, Antonio Castro, Ariane Viveiros, Caroline Quiroz Robladillo, Devy Saito, Elisa Garcia, Guilherme Carrasco, Hector Gulzar, Javaria Chao, John de Nadai, Mariane Grana, Martin Lioliou, Olga Rossell Perry, Percy Eduardo Obando, Tomas Takada, Toshihiko Jeanneret, Valerie Rrcc, Bonadio |
| author_browse | Andino, Andres Babiker-Mohamed, Mohamed Carrasco, Hector Castro, Ariane Chan, Amy Chao, John Garcia Rodrigues, Andre Cervantes Garcia, Guilherme Grana, Martin Gulzar, Javaria Haseeb, Abdul Huerta, Rodrigo Jannati, Ali Jeanneret, Valerie LB, Filier León‐Justel, Antonio Lioliou, Olga Nakashima, Akio Obando, Tomas PEP, Teixeira Quiroz Robladillo, Devy Rossell Perry, Percy Eduardo Rrcc, Bonadio Saito, Elisa Santoro‐Lopes, Guilherme Takada, Toshihiko Viveiros, Caroline de Nadai, Mariane |
| author_facet | Jannati, Ali PEP, Teixeira Santoro‐Lopes, Guilherme Babiker-Mohamed, Mohamed Huerta, Rodrigo LB, Filier Haseeb, Abdul Nakashima, Akio Chan, Amy Garcia Rodrigues, Andre Cervantes Andino, Andres León‐Justel, Antonio Castro, Ariane Viveiros, Caroline Quiroz Robladillo, Devy Saito, Elisa Garcia, Guilherme Carrasco, Hector Gulzar, Javaria Chao, John de Nadai, Mariane Grana, Martin Lioliou, Olga Rossell Perry, Percy Eduardo Obando, Tomas Takada, Toshihiko Jeanneret, Valerie Rrcc, Bonadio |
| author_sort | Jannati, Ali |
| collection | Producción científica |
| description | Stroke is a leading cause of disability among adults. Existing rehabilitation programs haven’t been able to accomplish full motor recovery partially due to the pathologic plasticity exerted from the unaffected hemisphere to the affected one. This inhibition can be disrupted using non-invasive brain stimulation (NIBS). Transcranial magnetic stimulation (TMS) is a NIBS technique that has the capacity of depolarizing or hyperpolarizing neurons depending on the frequency of the pulses. Although several trials have been conducted to find the efficacy of low frequency rTMS for motor recovery after stroke, their results have been heterogeneous. One of the main variables that determine the response to rTMS is the dose, corresponding to the number of pulses delivered to the patients. However, due to the localization and the extension of the stroke, each patient responds differently to certain dose. Therefore, using the SPIRIT statement, we designed a protocol for an adaptive, phase II, randomized, sham-controlled clinical trial. The study proposed will include 75 patients between 45 and 80 years old, with hand function impairment after 1 to 3 years of stroke; it will exclude patients with severe cognitive or neuropsychiatric comorbilities, any previous stroke episode, Fugl Meyer (Upper limb) < 20, inability to understand the task or contraindications for rTMS. The study will have 3 arms: individually tailored (adaptive dosing) low frequency (1Hz) rTMS plus standard of care rehabilitation (physical therapy) compared to sham and fixed rTMS plus standard of care rehabilitation. The intervention will be applied during 6 weeks after which the main analysis will be performed. Subjects will be followed-up during 3 months and the results from this analysis will be exploratory. This protocol will use the results from the Pegboard test as a primary outcome and SF-36 questionnaire, hand strength, and responder´s rate as secondary outcomes. |
| format | Article |
| id | oai:cris.upeu.edu.pe:20.500.15037/1327 |
| institution | UPeU |
| language | English |
| publishDate | 2016 |
| publishDateRange | 2016 |
| publishDateSort | 2016 |
| record_format | dspace |
| spelling | oai:cris.upeu.edu.pe:20.500.15037/13272026-10-30T16:15:35ZThe effects of individually tailored rTMS on hand function in chronic stroke: a protocol for an adaptive, phase II, randomized, sham-controlled clinical trialJannati, AliPEP, TeixeiraSantoro‐Lopes, GuilhermeBabiker-Mohamed, MohamedHuerta, RodrigoLB, FilierHaseeb, AbdulNakashima, AkioChan, AmyGarcia Rodrigues, Andre CervantesAndino, AndresLeón‐Justel, AntonioCastro, ArianeViveiros, CarolineQuiroz Robladillo, DevySaito, ElisaGarcia, GuilhermeCarrasco, HectorGulzar, JavariaChao, Johnde Nadai, MarianeGrana, MartinLioliou, OlgaRossell Perry, Percy EduardoObando, TomasTakada, ToshihikoJeanneret, ValerieRrcc, BonadioChronic strokeRandomized controlled trialPhysical medicine and rehabilitationStroke (engine)MedicineProtocol (science)Transcranial magnetic stimulationPhysical therapyClinical trialRehabilitationSurgeryInternal medicineAlternative medicineStimulationPathologyPhysicsThermodynamicsLife Sciences Neuroscience Neurology Transcranial Magnetic Stimulation StudiesPhysical Sciences Engineering Biomedical Engineering Muscle activation and electromyography studiesHealth Sciences Medicine Rehabilitation Stroke Rehabilitation and RecoveryStroke is a leading cause of disability among adults. Existing rehabilitation programs haven’t been able to accomplish full motor recovery partially due to the pathologic plasticity exerted from the unaffected hemisphere to the affected one. This inhibition can be disrupted using non-invasive brain stimulation (NIBS). Transcranial magnetic stimulation (TMS) is a NIBS technique that has the capacity of depolarizing or hyperpolarizing neurons depending on the frequency of the pulses. Although several trials have been conducted to find the efficacy of low frequency rTMS for motor recovery after stroke, their results have been heterogeneous. One of the main variables that determine the response to rTMS is the dose, corresponding to the number of pulses delivered to the patients. However, due to the localization and the extension of the stroke, each patient responds differently to certain dose. Therefore, using the SPIRIT statement, we designed a protocol for an adaptive, phase II, randomized, sham-controlled clinical trial. The study proposed will include 75 patients between 45 and 80 years old, with hand function impairment after 1 to 3 years of stroke; it will exclude patients with severe cognitive or neuropsychiatric comorbilities, any previous stroke episode, Fugl Meyer (Upper limb) < 20, inability to understand the task or contraindications for rTMS. The study will have 3 arms: individually tailored (adaptive dosing) low frequency (1Hz) rTMS plus standard of care rehabilitation (physical therapy) compared to sham and fixed rTMS plus standard of care rehabilitation. The intervention will be applied during 6 weeks after which the main analysis will be performed. Subjects will be followed-up during 3 months and the results from this analysis will be exploratory. This protocol will use the results from the Pegboard test as a primary outcome and SF-36 questionnaire, hand strength, and responder´s rate as secondary outcomes.Articlehttps://doi.org/10.21801/issn.2378-1890.2016.610.21801/issn.2378-1890.2016.6https://hdl.handle.net/20.500.15037/1327W2401298370enPrinciples and Practice of Clinical Research2016-03-152026-06-13T09:53:28Z2026-06-13T09:53:28Z |
| spellingShingle | Chronic stroke Randomized controlled trial Physical medicine and rehabilitation Stroke (engine) Medicine Protocol (science) Transcranial magnetic stimulation Physical therapy Clinical trial Rehabilitation Surgery Internal medicine Alternative medicine Stimulation Pathology Physics Thermodynamics Life Sciences Neuroscience Neurology Transcranial Magnetic Stimulation Studies Physical Sciences Engineering Biomedical Engineering Muscle activation and electromyography studies Health Sciences Medicine Rehabilitation Stroke Rehabilitation and Recovery Jannati, Ali PEP, Teixeira Santoro‐Lopes, Guilherme Babiker-Mohamed, Mohamed Huerta, Rodrigo LB, Filier Haseeb, Abdul Nakashima, Akio Chan, Amy Garcia Rodrigues, Andre Cervantes Andino, Andres León‐Justel, Antonio Castro, Ariane Viveiros, Caroline Quiroz Robladillo, Devy Saito, Elisa Garcia, Guilherme Carrasco, Hector Gulzar, Javaria Chao, John de Nadai, Mariane Grana, Martin Lioliou, Olga Rossell Perry, Percy Eduardo Obando, Tomas Takada, Toshihiko Jeanneret, Valerie Rrcc, Bonadio The effects of individually tailored rTMS on hand function in chronic stroke: a protocol for an adaptive, phase II, randomized, sham-controlled clinical trial |
| title | The effects of individually tailored rTMS on hand function in chronic stroke: a protocol for an adaptive, phase II, randomized, sham-controlled clinical trial |
| title_full | The effects of individually tailored rTMS on hand function in chronic stroke: a protocol for an adaptive, phase II, randomized, sham-controlled clinical trial |
| title_fullStr | The effects of individually tailored rTMS on hand function in chronic stroke: a protocol for an adaptive, phase II, randomized, sham-controlled clinical trial |
| title_full_unstemmed | The effects of individually tailored rTMS on hand function in chronic stroke: a protocol for an adaptive, phase II, randomized, sham-controlled clinical trial |
| title_short | The effects of individually tailored rTMS on hand function in chronic stroke: a protocol for an adaptive, phase II, randomized, sham-controlled clinical trial |
| title_sort | effects of individually tailored rtms on hand function in chronic stroke a protocol for an adaptive phase ii randomized sham controlled clinical trial |
| topic | Chronic stroke Randomized controlled trial Physical medicine and rehabilitation Stroke (engine) Medicine Protocol (science) Transcranial magnetic stimulation Physical therapy Clinical trial Rehabilitation Surgery Internal medicine Alternative medicine Stimulation Pathology Physics Thermodynamics Life Sciences Neuroscience Neurology Transcranial Magnetic Stimulation Studies Physical Sciences Engineering Biomedical Engineering Muscle activation and electromyography studies Health Sciences Medicine Rehabilitation Stroke Rehabilitation and Recovery |
| topic_facet | Chronic stroke Randomized controlled trial Physical medicine and rehabilitation Stroke (engine) Medicine Protocol (science) Transcranial magnetic stimulation Physical therapy Clinical trial Rehabilitation Surgery Internal medicine Alternative medicine Stimulation Pathology Physics Thermodynamics Life Sciences Neuroscience Neurology Transcranial Magnetic Stimulation Studies Physical Sciences Engineering Biomedical Engineering Muscle activation and electromyography studies Health Sciences Medicine Rehabilitation Stroke Rehabilitation and Recovery |
| url | https://doi.org/10.21801/issn.2378-1890.2016.6 https://hdl.handle.net/20.500.15037/1327 |
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