Acute Ischemic Stroke
Conditions
Brief summary
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.
Interventions
DEVICEEEG-based non-invasive brain-computer interface (BCI) virtual hand/gait training system
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.
BEHAVIORALStandard Early Rehabilitation
Participants receive site-standard early rehabilitation according to the local rehabilitation protocol.
Sponsors
Shandong Provincial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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. * 5\. Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score of 10 to 50 at T0. * 6\. Pre-stroke modified Rankin Scale (mRS) score \<= 2. * 7\. Written informed consent provided by the participant and ability to comply with training and follow-up; if necessary, consent may be provided by a legally authorized representative.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| National Institutes of Health Stroke Scale (NIHSS) score | Day 10 (±2 days), Day 30, Day 90 | Neurological deficit severity assessed using the National Institutes of Health Stroke Scale. Lower scores indicate less severe neurological impairment. |
| Modified Rankin Scale (mRS) score | Day 30, Day 90 | Global disability assessed using the modified Rankin Scale. Lower scores indicate less disability and greater functional independence. |
| Barthel Index (BI) / Modified Barthel Index (MBI) score | Day 10 (±2 days), Day 30, Day 90 | 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. |
| 10-Meter Walk Test (10MWT) performance | Day 10 (±2 days), Day 30, Day 90 | 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. |
| Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score | Day 10 (±2 days), Day 30, Day 90 | 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 | Day 10 (±2 days), Day 30, Day 90 | 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 | Day 10 (±2 days), Day 30, Day 90 | Lower-extremity motor impairment assessed using the Fugl-Meyer Assessment for Lower Extremity. Higher scores indicate better lower-extremity motor function. |
| Timed Up and Go (TUG) test performance | Day 10 (±2 days), Day 30, Day 90 | 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. |
| Functional Ambulation Category (FAC) score | Day 10 (±2 days), Day 30, Day 90 | Walking ability assessed using the Functional Ambulation Category. Higher scores indicate greater independence in ambulation. |
Contacts
CONTACTWang Chen, MD
PRINCIPAL_INVESTIGATORQinJian Sun, MD
Shandong Provincial Hospital
Outcome results
None listed