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Transcranial Stimulation and Motor Training in Stroke Rehabilitation (tDCS)

19 de junho de 2012 atualizado por: University of Oxford

Transcranial Direct Current Stimulation (tDCS) as a Potential Adjunct Intervention in Stroke Rehabilitation

This study aims to test whether repeated sessions of tDCS result in long-lasting improvements in motor function in patients with chronic stroke.

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Descrição detalhada

Previous research that utilises single sessions of tDCS have demonstrated functional improvements; however, these improvements are usually short-lived, lasting less than one hour before the patient's performance returns to baseline. It has been suggested that repeated stimulation sessions are required to elicit long-lasting improvements. We aim to consider these details over the duration of this research, during which patients with chronic stroke will attend for 16 sessions over the course of 3 months.

This research has important implications; previous studies suggest that such an approach has the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a clinically viable rehabilitative tool. Recovery of motor skills may take many months to acquire and therefore strategies that have the potential to enhance acquisition of skill are of practical and scientific interest.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

80

Estágio

  • Fase 2
  • Fase 3

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.

Locais de estudo

  • Reino Unido
      • Oxford, Reino Unido
        • Recrutamento
        • Centre for Functional MRI of the Brain (FMRIB)

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

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 - 80 years.
  • Patients should be at least six months post first symptomatic stroke affecting motor function of the hand.

Exclusion Criteria:

  • Anyone who does not have adequate understanding of verbal and written information in English, sufficient to complete any of the safety screening forms.
  • Anyone who has a previous history of epilepsy, febrile convulsions as a child or recurrent fainting fits. Likewise, anyone who has a significant family history of epilepsy would be excluded as all these conditions carry a theoretical risk of increasing susceptibility to seizures.
  • Any person who has a history of drug abuse or a previous history of a neurological or psychiatric illness, or has a history of neurosurgical procedure is excluded as they may be at increased risk of epilepsy and data collected may be influenced by their condition.
  • Patients on some prescription medications such as anti-depressants may be excluded as they may be at an increased risk of seizures.
  • Anyone who is currently taking or who has taken anti-malarial treatment in the last 72 hours.
  • Pregnant women are excluded as a precaution as there is no data on the effect on maternal cranial stimulation on the fetus.
  • Any metallic implant in the neck, head, or eye and anyone with any implanted electrical devices would be excluded as there is a risk of heating with both TMS and TDCS stimulation.
  • Anyone with any metal implants or implantable device would be excluded as indicated by the MRI safety screening form. People who suffer with claustrophobia as they are unable to tolerate the scanner.
  • Patients who have had more than one stroke. Patients who have had a stroke will also be excluded if they have limited communication in the form of aphasia or a history of dementia.

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: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Anodal tDCS and Motor Training
Participants will receive anodal tDCS over the primary motor cortex of the ipsilesional hemisphere. The following parameters will be used: stimulation intensity of 1mA for the first 20 minutes of motor training (9 consecutive sessions Monday-Friday).
Dispositivo: Anodal tDCS
Participants will receive anodal tDCS over the primary motor cortex of the ipsilesional hemisphere. The following parameters will be used: stimulation intensity of 1mA for the first 20 minutes of motor training (9 consecutive sessions Monday-Friday).
Outro: Motor Training
All participants will receive a standardised motor training intervention for the upper paretic limb
Comparador Falso: Sham tDCS and Motor Training
Participants will receive sham tDCS over the primary motor cortex of the ipsilesional hemisphere for the first 20 minutes of motor training (9 consecutive sessions Monday-Friday).
Outro: Motor Training
All participants will receive a standardised motor training intervention for the upper paretic limb

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Fugl Meyer Assessment of Motor Recovery following Stroke
Prazo: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
Wolf Motor Function Test
Prazo: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
Action Research Arm Test
Prazo: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
9 Hole Peg Test
Prazo: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Reaction Time Test
Prazo: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
Stroke Impact Scale
Prazo: Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Oxford

Colaboradores

National Institute for Health Research, United Kingdom
The Dunhill Medical Trust

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

1 de janeiro de 2011

Conclusão Primária (Antecipado)

1 de dezembro de 2013

Conclusão do estudo (Antecipado)

1 de dezembro de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

4 de agosto de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de agosto de 2011

Primeira postagem (Estimativa)

11 de agosto de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

20 de junho de 2012

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de junho de 2012

Última verificação

1 de junho de 2012

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 10/H0604/98

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 .

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