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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental BCI Rehabilitation Group | Experimental | Standard early rehabilitation plus early EEG-BCI dual-module virtual hand and gait training |
|
| Standard Early Rehabilitation Group | Active Comparator | Standard early rehabilitation without additional BCI training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG-based non-invasive brain-computer interface (BCI) virtual hand/gait training system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (T0), Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 10 (±2 days), Day 30, Day 90 |
| Action Research Arm Test (ARAT) score |
| Measure | Description | Time Frame |
|---|---|---|
| Screening-to-enrollment ratio | 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 |
| Intervention adherence rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Chen, MD | Contact | +86-68773274 | chenwang@sph.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| QinJian Sun, MD | Shandong Provincial Hospital | Principal Investigator |
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The IPD will be available from Principal Investigators (Prof. Qinjian Sun) upon reasonable request 6 months after the trial completion.
IPD will be made available 6 months after the completion of the trial.
The IPD can be accessed by Principal Investigators (Prof. Qinjian Sun) 6 months after the completion of the trial, subject to a reasonable request.
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|
| Standard Early Rehabilitation | Behavioral | Participants receive site-standard early rehabilitation according to the local rehabilitation protocol. |
|
Upper-limb activity limitation assessed using the Action Research Arm Test. Higher scores indicate better upper-limb function. |
| Day 10 (±2 days), Day 30, Day 90 |
| 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. | Day 10 (±2 days), Day 30, Day 90 |
| Functional Ambulation Category (FAC) score | Walking ability assessed using the Functional Ambulation Category. Higher scores indicate greater independence in ambulation. | Day 10 (±2 days), Day 30, Day 90 |
| 10-Meter Walk Test (10MWT) performance | 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. | Day 10 (±2 days), Day 30, Day 90 |
| Timed Up and Go (TUG) test performance | 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. | Day 10 (±2 days), Day 30, Day 90 |
| National Institutes of Health Stroke Scale (NIHSS) score | Neurological deficit severity assessed using the National Institutes of Health Stroke Scale. Lower scores indicate less severe neurological impairment. | Day 10 (±2 days), Day 30, Day 90 |
| Modified Rankin Scale (mRS) score | Global disability assessed using the modified Rankin Scale. Lower scores indicate less disability and greater functional independence. | Day 30, Day 90 |
| Barthel Index (BI) / Modified Barthel Index (MBI) score | 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. | Day 10 (±2 days), Day 30, Day 90 |
Feasibility outcome defined as the proportion of planned training sessions completed by each participant.
| During the 5-day intervention period |
| Effective BCI training duration | Feasibility outcome defined as the cumulative duration of valid BCI training completed during the intervention period. | During the 5-day 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. | During the 5-day intervention period |
| Follow-up completion rate | Feasibility outcome defined as the proportion of randomized participants who complete scheduled outcome assessments through Day 90. | Through Day 90 |
| Protocol deviation rate | Feasibility outcome defined as the proportion of participants with one or more protocol deviations. | From randomization through Day 90 |
| Incidence of symptomatic intracranial hemorrhage | Safety outcome defined as the occurrence of symptomatic intracranial hemorrhage after study enrollment. | From T0 through Day 30 |
| Incidence of any intracranial hemorrhage | Safety outcome defined as the occurrence of any type of intracranial hemorrhage after study enrollment. | From T0 through Day 30 |
| Incidence of neurological deterioration | Safety outcome defined as clinical neurological worsening after study enrollment according to the study protocol. | From T0 through Day 30 |
| Incidence of seizures | Safety outcome defined as the occurrence of seizure events after study enrollment. | From T0 through Day 30 |
| Incidence of falls | Safety outcome defined as the occurrence of falls during the study period. | From T0 through Day 30 |
| Incidence of blood pressure or cardiac rhythm adverse events | Safety outcome defined as blood pressure instability or cardiac arrhythmia events occurring during the study period. | From T0 through Day 30 |
| Incidence of puncture-site bleeding or hematoma | Safety outcome assessed in participants in the MT pathway, defined as puncture-site bleeding or hematoma after mechanical thrombectomy. | From T0 through Day 30 |
| Incidence of training-related discomfort | 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 |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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