Safety and Efficacy of Early Brain-Computer Interface Training After Reperfusion Therapy in Acute Ischemic Stroke (RT-BCI)
8 de maio de 2026 atualizado por: Shandong Provincial Hospital
This is a multicenter, prospective, randomized controlled trial designed to evaluate the efficacy, safety, and feasibility of early EEG-based non-invasive brain-computer interface (EEG-BCI) training as an add-on to standard early rehabilitation in patients with acute ischemic stroke (AIS) after reperfusion therapy. Eligible participants are adults aged 18 to 80 years with unilateral limb motor dysfunction after intravenous thrombolysis (IVT) and/or mechanical thrombectomy (MT). Participants will be randomized to receive either standard early rehabilitation plus closed-loop EEG-BCI dual-module virtual hand and gait training, or standard early rehabilitation alone.
The EEG-BCI intervention includes upper-limb virtual hand training and lower-limb gait/ankle dorsiflexion training, delivered twice daily for approximately 20 minutes per session over 5 consecutive days. The primary outcome is the change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score from baseline (T0) to Day 30. Secondary outcomes include upper- and lower-limb motor function, ambulation, neurological status, disability, and activities of daily living. Safety and feasibility outcomes will also be assessed.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
60
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: Wang Chen, MD
- Número de telefone: +86-68773274
- E-mail: chenwang@sph.com.cn
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:
- 1. Age 18 to 80 years.
- 2. Acute ischemic stroke (AIS) treated with reperfusion therapy, including intravenous thrombolysis (IVT) and/or mechanical thrombectomy (MT); for participants undergoing MT, successful recanalization during the procedure defined as eTICI 2b-3.
- 3. Meets the protocol-defined clinical stability criteria for the corresponding treatment pathway (see Section 4.3).
- 4. Unilateral limb motor dysfunction on the same side as the dominant hand.
- 5. Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score of 10 to 50 at T0.
- 6. Pre-stroke modified Rankin Scale (mRS) score <= 2.
- 7. Written informed consent provided by the participant and ability to comply with training and follow-up; if necessary, consent may be provided by a legally authorized representative.
Exclusion Criteria:
- 1. Imaging-confirmed symptomatic intracranial hemorrhage (sICH), or bleeding risk considered unacceptable by the investigator and requiring a change in treatment strategy.
- 2. Overt progressive neurological deterioration or need for urgent intervention, making training inappropriate, such as an increase in National Institutes of Health Stroke Scale (NIHSS) score of >=4 from a prior assessment with cause not yet clarified or stabilized.
- 3. Severe disturbance of consciousness, severe aphasia or neglect, or significant cognitive impairment that would prevent completion of BCI training tasks or primary outcome assessment.
- 4. Bilateral significant motor impairment, such as brainstem or bilateral lesions, or pre-existing moderate-to-severe disability of the contralateral upper or lower limb, which would interfere with training or interpretation of assessments under the unilateral impairment framework.
- 5. Severe comorbidity or unstable vital signs, including but not limited to unstable arrhythmia, severe heart failure or respiratory failure, active severe infection or sepsis, or severe hepatic or renal failure, such that the investigator judges the participant unable to safely complete training and follow-up.
- 6. Severe scalp skin damage or infection, or any other condition preventing safe use of the EEG electrode cap.
- 7. Frequent seizures within 7 days before randomization, or seizure risk considered unacceptable by the investigator.
- 8. Pregnancy or breastfeeding.
- 9. Participation in another interventional clinical study that may affect the outcomes of this study, or any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Experimental BCI Rehabilitation Group
Standard early rehabilitation plus early EEG-BCI dual-module virtual hand and gait training
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Dispositivo: EEG-based non-invasive brain-computer interface (BCI) virtual hand/gait training system
Closed-loop EEG-based non-invasive brain-computer interface training added to standard early rehabilitation, including virtual hand training for the upper limb and gait/ankle dorsiflexion training for the lower limb.
Training is delivered twice daily, approximately 20 minutes per session, for 5 consecutive days.
Participants receive site-standard early rehabilitation according to the local rehabilitation protocol.
|
|
Comparador Ativo: Standard Early Rehabilitation Group
Standard early rehabilitation without additional BCI training.
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Participants receive site-standard early rehabilitation according to the local rehabilitation protocol.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score
Prazo: Baseline (T0), Day 30
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Change is calculated as the Day 30 FMA-UE score minus the baseline (T0) FMA-UE score.
Higher positive values indicate greater improvement in upper-extremity motor function.
T0 is defined as 48 hours after IVT for the IVT-only pathway, and Day 5 (120 ± 24 hours) after MT for the MT ± IVT pathway.
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Baseline (T0), Day 30
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score
Prazo: Day 10 (±2 days), Day 30, Day 90
|
Upper-extremity motor impairment assessed using the Fugl-Meyer Assessment for Upper Extremity.
Higher scores indicate better upper-extremity motor function.
|
Day 10 (±2 days), Day 30, Day 90
|
|
Action Research Arm Test (ARAT) score
Prazo: Day 10 (±2 days), Day 30, Day 90
|
Upper-limb activity limitation assessed using the Action Research Arm Test.
Higher scores indicate better upper-limb function.
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Day 10 (±2 days), Day 30, Day 90
|
|
Fugl-Meyer Assessment for Lower Extremity (FMA-LE) score
Prazo: Day 10 (±2 days), Day 30, Day 90
|
Lower-extremity motor impairment assessed using the Fugl-Meyer Assessment for Lower Extremity.
Higher scores indicate better lower-extremity motor function.
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Day 10 (±2 days), Day 30, Day 90
|
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Functional Ambulation Category (FAC) score
Prazo: Day 10 (±2 days), Day 30, Day 90
|
Walking ability assessed using the Functional Ambulation Category.
Higher scores indicate greater independence in ambulation.
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Day 10 (±2 days), Day 30, Day 90
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10-Meter Walk Test (10MWT) performance
Prazo: Day 10 (±2 days), Day 30, Day 90
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Walking performance assessed by the 10-Meter Walk Test in participants who meet prespecified walking criteria.
Walking speed and/or time required to complete the test will be recorded.
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Day 10 (±2 days), Day 30, Day 90
|
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Timed Up and Go (TUG) test performance
Prazo: Day 10 (±2 days), Day 30, Day 90
|
Functional mobility assessed by the Timed Up and Go test in participants who meet prespecified walking criteria.
Time required to complete the test will be recorded.
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Day 10 (±2 days), Day 30, Day 90
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National Institutes of Health Stroke Scale (NIHSS) score
Prazo: Day 10 (±2 days), Day 30, Day 90
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Neurological deficit severity assessed using the National Institutes of Health Stroke Scale.
Lower scores indicate less severe neurological impairment.
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Day 10 (±2 days), Day 30, Day 90
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Modified Rankin Scale (mRS) score
Prazo: Day 30, Day 90
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Global disability assessed using the modified Rankin Scale.
Lower scores indicate less disability and greater functional independence.
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Day 30, Day 90
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Barthel Index (BI) / Modified Barthel Index (MBI) score
Prazo: Day 10 (±2 days), Day 30, Day 90
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Activities of daily living assessed using the Barthel Index or Modified Barthel Index, according to the scale used at each study site.
Higher scores indicate better functional independence in daily activities.
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Day 10 (±2 days), Day 30, Day 90
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Screening-to-enrollment ratio
Prazo: Through completion of recruitment, an estimated 16 months
|
Feasibility outcome defined as the number of participants enrolled and randomized divided by the total number of participants screened.
|
Through completion of recruitment, an estimated 16 months
|
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Intervention adherence rate
Prazo: During the 5-day intervention period
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Feasibility outcome defined as the proportion of planned training sessions completed by each participant.
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During the 5-day intervention period
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Effective BCI training duration
Prazo: During the 5-day intervention period
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Feasibility outcome defined as the cumulative duration of valid BCI training completed during the intervention period.
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During the 5-day intervention period
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EEG signal quality and classification accuracy
Prazo: During the 5-day intervention period
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Feasibility outcome assessing the quality of EEG acquisition and the performance of signal classification during BCI training sessions.
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During the 5-day intervention period
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Follow-up completion rate
Prazo: Through Day 90
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Feasibility outcome defined as the proportion of randomized participants who complete scheduled outcome assessments through Day 90.
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Through Day 90
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Protocol deviation rate
Prazo: From randomization through Day 90
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Feasibility outcome defined as the proportion of participants with one or more protocol deviations.
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From randomization through Day 90
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Incidence of symptomatic intracranial hemorrhage
Prazo: From T0 through Day 30
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Safety outcome defined as the occurrence of symptomatic intracranial hemorrhage after study enrollment.
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From T0 through Day 30
|
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Incidence of any intracranial hemorrhage
Prazo: From T0 through Day 30
|
Safety outcome defined as the occurrence of any type of intracranial hemorrhage after study enrollment.
|
From T0 through Day 30
|
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Incidence of neurological deterioration
Prazo: From T0 through Day 30
|
Safety outcome defined as clinical neurological worsening after study enrollment according to the study protocol.
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From T0 through Day 30
|
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Incidence of seizures
Prazo: From T0 through Day 30
|
Safety outcome defined as the occurrence of seizure events after study enrollment.
|
From T0 through Day 30
|
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Incidence of falls
Prazo: From T0 through Day 30
|
Safety outcome defined as the occurrence of falls during the study period.
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From T0 through Day 30
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Incidence of blood pressure or cardiac rhythm adverse events
Prazo: From T0 through Day 30
|
Safety outcome defined as blood pressure instability or cardiac arrhythmia events occurring during the study period.
|
From T0 through Day 30
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Incidence of puncture-site bleeding or hematoma
Prazo: From T0 through Day 30
|
Safety outcome assessed in participants in the MT pathway, defined as puncture-site bleeding or hematoma after mechanical thrombectomy.
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From T0 through Day 30
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Incidence of training-related discomfort
Prazo: During the 5-day intervention period
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Safety outcome defined as training-related discomfort, including fatigue, headache, skin irritation, or other reported discomfort associated with the intervention.
|
During the 5-day intervention period
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: QinJian Sun, MD, Shandong Provincial Hospital
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 abril de 2026
Conclusão Primária (Estimado)
1 de abril de 2027
Conclusão do estudo (Estimado)
1 de junho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
29 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de maio de 2026
Primeira postagem (Real)
13 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de maio de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RT-BCI-2026-0219
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
The IPD will be available from Principal Investigators (Prof.
Qinjian Sun) upon reasonable request 6 months after the trial completion.
Prazo de Compartilhamento de IPD
IPD will be made available 6 months after the completion of the trial.
Critérios de acesso de compartilhamento IPD
The IPD can be accessed by Principal Investigators (Prof.
Qinjian Sun) 6 months after the completion of the trial, subject to a reasonable request.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
- CSR
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
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