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.
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.
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.
Parallel
EEG-based non-invasive brain-computer interface (BCI) virtual hand/gait training system
DeviceClosed-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.
Standard Early Rehabilitation
BehavioralParticipants receive site-standard early rehabilitation according to the local rehabilitation protocol.
Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score
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.
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score
Upper-extremity motor impairment assessed using the Fugl-Meyer Assessment for Upper Extremity. Higher scores indicate better upper-extremity motor function.
Action Research Arm Test (ARAT) score
Upper-limb activity limitation assessed using the Action Research Arm Test. Higher scores indicate better upper-limb function.
Fugl-Meyer Assessment for Lower Extremity (FMA-LE) score
Lower-extremity motor impairment assessed using the Fugl-Meyer Assessment for Lower Extremity. Higher scores indicate better lower-extremity motor function.
Functional Ambulation Category (FAC) score
Walking ability assessed using the Functional Ambulation Category. Higher scores indicate greater independence in ambulation.
Screening-to-enrollment ratio
Feasibility outcome defined as the number of participants enrolled and randomized divided by the total number of participants screened.
Intervention adherence rate
Feasibility outcome defined as the proportion of planned training sessions completed by each participant.
Effective BCI training duration
Feasibility outcome defined as the cumulative duration of valid BCI training completed during the intervention period.
EEG signal quality and classification accuracy
Feasibility outcome assessing the quality of EEG acquisition and the performance of signal classification during BCI training sessions.
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