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.
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.
None
Parallel
Real EEG-BCI Training
DeviceNon-invasive EEG-based brain-computer interface training combined with standard early rehabilitation. The intervention includes EEG signal acquisition, motor intention decoding, and real-time virtual hand feedback. Participants perform upper extremity motor imagery or motor attempt tasks. Training is delivered twice daily for approximately 30 minutes per session for 10 consecutive days.
Sham BCI Training
DeviceSham BCI training designed to maintain participant masking. The procedure matches real EEG-BCI training in device setup, training environment, frequency, duration, and workflow, but the feedback is not linked to the participant's real-time EEG motor intention decoding.
Standard Early Rehabilitation
BehavioralParticipants in both groups will receive standard early rehabilitation according to clinical practice, including appropriate physical therapy, occupational therapy, task-oriented training, positioning, and other routine rehabilitation interventions.
Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) Score From Baseline to Day 30
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.
Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) Score
Upper extremity motor function will be assessed using the FMA-UE. The total score ranges from 0 to 66, with higher scores indicating better motor function.
Action Research Arm Test (ARAT) Score
Upper extremity activity performance will be assessed using the ARAT. The total score ranges from 0 to 57, with higher scores indicating better upper limb functional ability.
National Institutes of Health Stroke Scale (NIHSS) Score
Neurological impairment will be assessed using the NIHSS. Scores range from 0 to 42, with higher scores indicating greater neurological deficit.
Modified Rankin Scale (mRS) Score
Global functional outcome will be assessed using the modified Rankin Scale. Scores range from 0 to 6, with higher scores indicating greater disability.
Training Completion Rate
Feasibility outcome defined as the proportion of completed EEG-BCI or sham BCI training sessions among the planned 20 sessions.
Effective Training Duration
Feasibility outcome defined as the cumulative duration of completed valid BCI training sessions during the intervention period.
EEG Signal Quality and BCI Performance Metrics
Feasibility outcome assessing EEG acquisition quality and available BCI performance metrics, including signal quality and classification accuracy when available.
Follow-up completion rate
Feasibility outcome defined as the proportion of randomized participants who complete scheduled outcome assessments through Day 90.
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