Safety and Efficacy of Early Brain-Computer Interface Training After Reperfusion Therapy in Acute Ischemic Stroke

Обзор

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.

Вмешательства

• Устройство EEG-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.
• Поведенческое Standard Early Rehabilitation
  Participants receive site-standard early rehabilitation according to the local rehabilitation protocol.

Первичные конечные точки

• Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score [Срок оценки: Baseline (T0), Day 30]

Вторичные конечные точки (9)

• Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score [Срок оценки: Day 10 (±2 days), Day 30, Day 90]
• Action Research Arm Test (ARAT) score [Срок оценки: Day 10 (±2 days), Day 30, Day 90]
• Fugl-Meyer Assessment for Lower Extremity (FMA-LE) score [Срок оценки: Day 10 (±2 days), Day 30, Day 90]
• Functional Ambulation Category (FAC) score [Срок оценки: Day 10 (±2 days), Day 30, Day 90]
• 10-Meter Walk Test (10MWT) performance [Срок оценки: Day 10 (±2 days), Day 30, Day 90]
• Timed Up and Go (TUG) test performance [Срок оценки: Day 10 (±2 days), Day 30, Day 90]
• National Institutes of Health Stroke Scale (NIHSS) score [Срок оценки: Day 10 (±2 days), Day 30, Day 90]
• Modified Rankin Scale (mRS) score [Срок оценки: Day 30, Day 90]
• Barthel Index (BI) / Modified Barthel Index (MBI) score [Срок оценки: Day 10 (±2 days), Day 30, Day 90]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07585058 · RT-BCI-2026-0219

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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