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Safety and Efficacy of Early Non-invasive Brain-Computer Interface-Based Rehabilitation in Acute Ischemic Stroke
Sponsor: Shandong Provincial Hospital
Summary
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.
Official title: Safety and Efficacy of Early Non-invasive Brain-Computer Interface-Based Rehabilitation Training in Patients With Acute Ischemic Stroke: The SeeBCI Study
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-10
Completion Date
2027-12
Last Updated
2026-09-25
Healthy Volunteers
No
Interventions
Real EEG-BCI Training
Non-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
Sham 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
Participants 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.