Optimal Targeted High-definition Transcranial Direct Current Stimulation for Reducing Post-stroke Upper Limb Motor Impairments
26 de maio de 2026 atualizado por: Yuan Yang, Carle Foundation Hospital
Optimal Targeted High-definition tDCS for Reducing Post-stroke Upper Limb Motor Impairments
Non-invasive, non-pharmaceutical technologies that augment routine clinical practice for brain diseases and manage chronic symptoms have advanced rapidly over the past two decades.
Among these, non-invasive brain stimulation such as transcranial direct current stimulation (tDCS) promotes neuroplasticity in injured brains, with fewer side effects and risks than invasive, implanted approaches such as deep-brain stimulation.
Stimulating the brain can improve its function and help with recovery after a stroke.
It has been a challenge to do this non-invasively.
This is because the brain is reshaped after a stroke, and thus, it is difficult to find the right places to stimulate from the outside.
In previous research, investigators found that optimal type and target of tDCS varied among subjects.
The goal of this pilot trial is to test the feasibility of combining individually optimized, targeted high-definition tDCS (THD-tDCS) with rehabilitation therapy.
Investigators will include 16 chronic stroke subjects with their optimal stimulation setup, obtained from their previous research.
The participants will be computer-randomized into two equal-sized groups to receive either optimal THD-tDCS or sham stimulation, together with rehabilitation therapy (modified constraint-induced movement therapy, mCIMT) for five sessions over two weeks.
Outcome measures will be collected at the baseline and right after the final intervention session.
The primary outcome measure will be the change in the FM-UE score from baseline to immediately post the final intervention to assess the immediate effect of the intervention on upper extremity motor impairment.
The secondary outcome measure will be the Wolf Motor Function Test time score to evaluate the immediate effect on functional motor performance.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
16
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Sanjiv Jain, MD
- Número de telefone: 217-383-3800
- E-mail: sanjiv.jain@carle.com
Estude backup de contato
- Nome: Yuan Yang, PhD, MS
- Número de telefone: 217-244-5870
- E-mail: yuan.yang@carle.com
Locais de estudo
-
-
Illinois
-
Urbana, Illinois, Estados Unidos, 61801-3028
- Carle Foundation Hospital
-
Investigador principal:
- Yuan Yang, PhD, MS
-
Contato:
- Carly Skadden, MPH
- Número de telefone: 1 217-326-0102
- E-mail: carly.skadden@carle.com
-
Subinvestigador:
- Sanjiv Jain, MD
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Must be 18 years or older
- Must have had a stroke that resulted in paresis confined to one side. The use of a wheelchair or other assisting devices are not exclusionary.
- Must have substantial motor impairment of the paretic upper limb
- Absence of severe wasting or contracture or significant sensory deficits in the paretic upper limb
- Absence of severe concurrent medical problems (e.g. cardiorespiratory impairment)
- Fugl-Meyer Upper Extremity Score of 8-50 based on assessment performed during the baseline visit.
- Must have had either MRI or CT of the brain performed at Carle as part of their stroke care. Imaging may have been performed either during the diagnostic work-up for stroke or as follow-up after diagnosis. The most recent images from either MRI or CT will be collected for this study.
- Capacity to provide informed consent and participate in English (Since this study is a clinical trial and the team is yet to provide the translation service at this stage, the study is restricted to those who can consent and participate in English only).
- Must be willing and able to perform study procedures
Exclusion Criteria:
- Self-reported sensitive skin or adhesive allergy as assessed by the tDCS Safety Screening Questionnaire
- Has a cardiac pacemaker, defibrillator or an implantable cardiac resynchronization therapy device
- Has metal implants in the head and/or brain
- Presence of muscle tone abnormalities and motor or sensory impairment in the non-paretic limb
- Presence of severe muscle wasting or contracture or significant sensory deficits in the paretic upper limb
- Currently pregnant or planning to become pregnant during the study period
- History of epilepsy, febrile convulsion, recurrent fainting spells or unexplained recurring headaches
- Current use of illicit/recreational drugs
- Currently undergoing anti-malarial treatment. (Note: participants can be considered for study participation after ant-malarial treatment has been discontinued)
- Has known adverse reaction to TMS or tDCS
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Optimal targeted HD-tDCS + mCIMT
Optimal targeted HD-tDCS (high-definition transcranial direct current stimulation) during Constraint Induced Movement Therapy (mCIMT)
|
High-definition transcranial direct stimulation with individualized, optimal parameters.
Modified Constraint-Induced Movement Therapy (mCIMT) is an evidence-based neurorehabilitation approach that improves upper limb function after stroke or brain injury by restricting the unaffected limb while intensively training the affected limb.
|
|
Comparador Falso: Sham HD-tDCS + mCIMT
Sham HD-tDCS (high-definition transcranial direct current stimulation) administers no dose or zero milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
|
Modified Constraint-Induced Movement Therapy (mCIMT) is an evidence-based neurorehabilitation approach that improves upper limb function after stroke or brain injury by restricting the unaffected limb while intensively training the affected limb.
High-definition transcranial direct stimulation with zero stimulation intensity (placebo)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in the Fugl-Meyer Upper Extremity score from baseline
Prazo: Right after the final intervention session
|
Fugl-Meyer Upper Extremity (FM-UE) is a measure of motor impairment (0 to 66 points, with higher points indicating less impairment).
FM-UE scale consists of a 33-item assessment which provides a global assessment of upper extremity motor impairment.
A rater provides an ordinal rating (2=near normal ability/response, 1=partial ability, 0=unable to perform/no response) for each item.
|
Right after the final intervention session
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in the Wolf Motor Function Test Time Score From Baseline
Prazo: Right after the final intervention session
|
Wolf Motor Function (WMFT) Test is a measure of functional motor activity that quantifies upper extremity motor ability through timed and functional tasks.
The WMFT Time Score the median of 15 timed arm movements and hand dexterity tasks, each to be completed up to 120s.
If a task could not be completed in 120s, a score of 121s was assigned.
Higher score indicates a worse motor function.
|
Right after the final intervention session
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de julho de 2026
Conclusão Primária (Estimado)
31 de março de 2027
Conclusão do estudo (Estimado)
30 de junho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
14 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de maio de 2026
Primeira postagem (Real)
20 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
28 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de maio de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 26CNI4419
- 26BCDA1622682 (Número de outro subsídio/financiamento: American Heart Association)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
I will follow American Heart Association Open Science Policy to share IPD: https://professional.heart.org/en/research-programs/awardee-resources/open-science-policy-statements-for-aha-funded-research
Prazo de Compartilhamento de IPD
Please refer to https://professional.heart.org/en/research-programs/awardee-resources/open-science-policy-statements-for-aha-funded-research
for detailed information in term of time-frame of sharing such data
Critérios de acesso de compartilhamento IPD
Please refer to https://professional.heart.org/en/research-programs/awardee-resources/open-science-policy-statements-for-aha-funded-research
for detailed information in term of access criteria
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .