Safety and Efficacy of Early Non-invasive Brain-Computer Interface-Based Rehabilitation Training in Patients With Acute Ischemic Stroke: The SeeBCI Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) Score From Baseline to Day 30
研究概览
简要总结
This is a single-center, prospective, randomized, sham-controlled pilot clinical study designed to evaluate the efficacy, safety, and feasibility of early non-invasive electroencephalography-based brain-computer interface (EEG-BCI) rehabilitation training in patients with acute ischemic stroke.
Eligible participants are adults aged 18 to 80 years with acute ischemic stroke, unilateral upper extremity motor impairment on the dominant-hand side, a baseline Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) score of 10 to 50, and confirmed clinical stability 48 to 72 hours after stroke onset.
Participants will be randomly assigned in a 1:1 ratio to receive either real EEG-BCI training plus standard early rehabilitation or sham BCI training plus standard early rehabilitation. Both groups will receive 10 days of training, with two sessions per day and approximately 30 minutes per session.
The primary outcome is the change in FMA-UE score from baseline to 30 days after randomization. Secondary outcomes include changes in FMA-UE, Action Research Arm Test (ARAT), National Institutes of Health Stroke Scale (NIHSS), Modified Barthel Index (MBI), and modified Rankin Scale (mRS). Safety outcomes include symptomatic intracranial hemorrhage, any intracranial hemorrhage, neurological deterioration, seizures, falls, cardiovascular events, and training-related adverse events.
This pilot study aims to provide preliminary evidence regarding the feasibility, safety, and potential efficacy of early EEG-BCI rehabilitation after acute ischemic stroke and to inform the design of future multicenter randomized controlled trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be masked to treatment allocation. The intervention operators cannot be masked because they are required to perform EEG-BCI or sham BCI procedures. Intervention operators will not participate in outcome assessments or statistical analyses.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years.
- •Diagnosis of acute ischemic stroke.
- •Stroke onset to randomization within 48 to 72 hours.
- •Meets predefined clinical stability criteria before randomization.
- •Unilateral upper extremity motor impairment on the dominant-hand side.
- •Baseline Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) score between 10 and
- •Pre-stroke modified Rankin Scale (mRS) score ≤
- •Written informed consent obtained from the participant or legally authorized representative.
排除标准
- •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.
研究组 & 干预措施
Real EEG-BCI Training + Standard Early Rehabilitation
Participants will receive real electroencephalography-based brain-computer interface (EEG-BCI) training combined with standard early rehabilitation. The EEG-BCI training uses upper extremity motor imagery or motor attempt tasks with real-time decoding of motor intention and virtual hand feedback. Training will be performed twice daily for approximately 30 minutes per session over 10 consecutive days (20 sessions in total).
干预措施: Real EEG-BCI Training (Device)
Real EEG-BCI Training + Standard Early Rehabilitation
Participants will receive real electroencephalography-based brain-computer interface (EEG-BCI) training combined with standard early rehabilitation. The EEG-BCI training uses upper extremity motor imagery or motor attempt tasks with real-time decoding of motor intention and virtual hand feedback. Training will be performed twice daily for approximately 30 minutes per session over 10 consecutive days (20 sessions in total).
干预措施: Standard Early Rehabilitation (Behavioral)
Sham BCI Training + Standard Early Rehabilitation
Participants will receive sham BCI training combined with standard early rehabilitation. The sham procedure will match the real EEG-BCI training in appearance, frequency, duration, and workflow, but the feedback will not be generated by real-time EEG-based motor intention decoding. Training will be performed twice daily for approximately 30 minutes per session over 10 consecutive days (20 sessions in total).
干预措施: Sham BCI Training (Device)
Sham BCI Training + Standard Early Rehabilitation
Participants will receive sham BCI training combined with standard early rehabilitation. The sham procedure will match the real EEG-BCI training in appearance, frequency, duration, and workflow, but the feedback will not be generated by real-time EEG-based motor intention decoding. Training will be performed twice daily for approximately 30 minutes per session over 10 consecutive days (20 sessions in total).
干预措施: Standard Early Rehabilitation (Behavioral)
结局指标
主要结局
Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) Score From Baseline to Day 30
时间窗: Baseline to Day 30 after randomization
The primary outcome is the change in FMA-UE score from baseline (T0) to 30 days after randomization. The FMA-UE evaluates upper extremity motor function after stroke, with scores ranging from 0 to 66. Higher scores indicate better upper extremity motor function. Change score is calculated as the FMA-UE score at Day 30 minus the baseline FMA-UE score.
Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score
时间窗: Baseline (T0), Day 30
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.
次要结局
- Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) Score(Baseline, Day 10, Day 30, and Day 90)
- Action Research Arm Test (ARAT) Score(Baseline, Day 30, and Day 90)
- National Institutes of Health Stroke Scale (NIHSS) Score(Baseline, Day 10, and Day 30)
- Modified Rankin Scale (mRS) Score(Day 90)
- Modified Barthel Index (MBI) Score(Day 30 and Day 90)
- Timed Up and Go (TUG) test performance(Day 10 (±2 days), Day 30, Day 90)
- National Institutes of Health Stroke Scale (NIHSS) score(Day 10 (±2 days), Day 30, Day 90)
- Modified Rankin Scale (mRS) score(Day 30, Day 90)
- Barthel Index (BI) / Modified Barthel Index (MBI) score(Day 10 (±2 days), Day 30, Day 90)
- Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score(Day 10 (±2 days), Day 30, Day 90)
- Action Research Arm Test (ARAT) score(Day 10 (±2 days), Day 30, Day 90)
- Fugl-Meyer Assessment for Lower Extremity (FMA-LE) score(Day 10 (±2 days), Day 30, Day 90)
- Functional Ambulation Category (FAC) score(Day 10 (±2 days), Day 30, Day 90)
- 10-Meter Walk Test (10MWT) performance(Day 10 (±2 days), Day 30, Day 90)