A Multi-center RCT Study on the Efficacy and Mechanism of Multi-channel tDCS in Rehabilitation of Cognitive Function After Stroke
This clinical RCT study intends to combined different forms of multi-channel tDCS with the routine cognitive training process to treat patients with post-stroke cognitive dysfunction.
The therapeutic effects among single-channel tDCS group, multi-channel tDCS and pseudo-multichannel tDCS group will be compared. Brain magnetic resonance mechanism research will also be included to reveal the possible mechanism of multi-channel tDCS technology for PSCI brain network.
Thus, the efficacy and mechanism of multi-channel tDCS in post-stroke cognitive function rehabilitation will be researched both in the clinical and basic levels.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Hongjie Jiang, Dr.
- Número de telefone: +86 13777830137
- E-mail: insjhj@zju.edu.cn
Locais de estudo
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Chongqing, China, 400000
- Recrutamento
- Southwest Hospital
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Contato:
- Jingming Hou, Dr.
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Zhejiang
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Hangzhou, Zhejiang, China, 310014
- Recrutamento
- Zhejiang Provincial People's Hospital
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Contato:
- Ruidong Cheng, Dr.
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Hangzhou, Zhejiang, China, 310009
- Recrutamento
- SAHZhejiangU
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Contato:
- Hongjie Jiang, Dr.
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Hangzhou, Zhejiang, China, 310000
- Recrutamento
- Rainbowfish Rehabilitation Nursing Care
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Contato:
- Ran Wang, Dr.
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 18-60 year-old
- diagnosed cerebral apoplexy, meeting the diagnostic criteria of ICD-10
- cognitive function, perceptual function decline after stroke
- first onset and duration of 3-12 months
- right-handed
- MMSE ≤25
- MoCA ≤25
- sign informed consent voluntarily and comply with the study plan
Exclusion Criteria:
- NIHSS ≥21 points
- MoCA ≤18, or DRS-2 ≤ 124, or CES-D ≥ 16
- taking drugs that affect central nervous activity, such as nerve antagonists
- specific contraindication, such as electrode patch allergy, local skin injury or - - - - inflammation, and hyperalgesia in stimulated areas
- patients use implantable electronic devices (such as cardiac pacemakers) or have - metal implants such as stents that affect MRI examination
- patients with a previous history of epilepsy, mental illness or skull injury
- patients with dementia or obvious cognitive dysfunction before stroke
- patients with aphasia or dysarthria and cannot complete the scale evaluation
- pregnancy
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: multi-channel tDCS
In the multi-channel tDCS stimulation group, a 1:4 (anode: cathode) approach was applied, with the central anode placed in the left dorsolateral prefrontal cortex (dlPFC) (reference 10-20 standard lead EEG), and the remaining cathode distributed around the central electrode. The rising time and falling time of current are 30 seconds respectively. Stimulate 30 minutes daily for 10 days (Monday to Friday, once a day, weekend off). |
multi-channel transcranial direct current stimulation, tDCS
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Experimental: single-channel tDCS
The anode electrode of the single-channel tDCS stimulation group was placed in the left dlPFC, and the cathode electrode was placed in the right orbital forehead. The rising time and falling time of current are 30 seconds respectively. Stimulate 30 minutes daily for 10 days (Monday to Friday, once a day, weekend off). |
single-channel transcranial direct current stimulation
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Comparador Falso: sham stimulation
The shame stimulation group had only 30 seconds of up and down stimulation, with no intermediate stimulation.
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multi-channel transcranial direct current stimulation, tDCS
single-channel transcranial direct current stimulation
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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MMSE
Prazo: Change from Baseline MMSE at 2 weeks and 3 months after intervention
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Mini-mental State Examination
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Change from Baseline MMSE at 2 weeks and 3 months after intervention
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MoCA
Prazo: Change from Baseline MoCA at 2 weeks and 3 months after intervention
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Montreal Cognitive Assessment
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Change from Baseline MoCA at 2 weeks and 3 months after intervention
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AVLT
Prazo: Change from Baseline AVLT at 2 weeks and 3 months after intervention
|
The Auditory-Verbal Learning Test
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Change from Baseline AVLT at 2 weeks and 3 months after intervention
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WAIS-DST
Prazo: Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention
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WAIS Digit Symbol Test
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Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
DEX
Prazo: Change from Baseline DEX at 2 weeks and 3 months after intervention
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Dysexecutive Ques-tionnaire
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Change from Baseline DEX at 2 weeks and 3 months after intervention
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GNAT
Prazo: Change from Baseline GNAT at 2 weeks and 3 months after intervention
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Go/No-go Association Task
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Change from Baseline GNAT at 2 weeks and 3 months after intervention
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Colaboradores e Investigadores
Investigadores
- Cadeira de estudo: Hongjie Jiang, Dr., Second Affiliated Hospital, School of Medicine, Zhejiang University
- Investigador principal: Ruidong Cheng, Dr., Zhejiang Provincial People's Hospital
- Investigador principal: Rang Wang, Dr., Rainbowfish Rehabilitation Nursing Care
- Investigador principal: Jingming Hou, Dr., Southwest Hospital, China
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2019-313
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