Safety and Efficacy of Early Brain-Computer Interface Training After Reperfusion Therapy in Acute Ischemic Stroke (RT-BCI)
2026년 5월 8일 업데이트: Shandong Provincial Hospital
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.
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Wang Chen, MD
- 전화번호: +86-68773274
- 이메일: chenwang@sph.com.cn
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Experimental BCI Rehabilitation Group
Standard early rehabilitation plus early EEG-BCI dual-module virtual hand and gait training
|
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.
Participants receive site-standard early rehabilitation according to the local rehabilitation protocol.
|
|
활성 비교기: Standard Early Rehabilitation Group
Standard early rehabilitation without additional BCI training.
|
Participants receive site-standard early rehabilitation according to the local rehabilitation protocol.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score
기간: 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.
|
Baseline (T0), Day 30
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score
기간: 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.
|
Day 10 (±2 days), Day 30, Day 90
|
|
Action Research Arm Test (ARAT) score
기간: 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.
|
Day 10 (±2 days), Day 30, Day 90
|
|
Fugl-Meyer Assessment for Lower Extremity (FMA-LE) score
기간: 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.
|
Day 10 (±2 days), Day 30, Day 90
|
|
Functional Ambulation Category (FAC) score
기간: Day 10 (±2 days), Day 30, Day 90
|
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
기간: 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.
|
Day 10 (±2 days), Day 30, Day 90
|
|
Timed Up and Go (TUG) test performance
기간: 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.
|
Day 10 (±2 days), Day 30, Day 90
|
|
National Institutes of Health Stroke Scale (NIHSS) score
기간: 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.
|
Day 10 (±2 days), Day 30, Day 90
|
|
Modified Rankin Scale (mRS) score
기간: Day 30, Day 90
|
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
기간: 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.
|
Day 10 (±2 days), Day 30, Day 90
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Screening-to-enrollment ratio
기간: Through completion of recruitment, an estimated 16 months
|
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
기간: During the 5-day intervention period
|
Feasibility outcome defined as the proportion of planned training sessions completed by each participant.
|
During the 5-day intervention period
|
|
Effective BCI training duration
기간: During the 5-day intervention period
|
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
기간: During the 5-day intervention period
|
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
기간: Through Day 90
|
Feasibility outcome defined as the proportion of randomized participants who complete scheduled outcome assessments through Day 90.
|
Through Day 90
|
|
Protocol deviation rate
기간: From randomization through Day 90
|
Feasibility outcome defined as the proportion of participants with one or more protocol deviations.
|
From randomization through Day 90
|
|
Incidence of symptomatic intracranial hemorrhage
기간: From T0 through Day 30
|
Safety outcome defined as the occurrence of symptomatic intracranial hemorrhage after study enrollment.
|
From T0 through Day 30
|
|
Incidence of any intracranial hemorrhage
기간: From T0 through Day 30
|
Safety outcome defined as the occurrence of any type of intracranial hemorrhage after study enrollment.
|
From T0 through Day 30
|
|
Incidence of neurological deterioration
기간: From T0 through Day 30
|
Safety outcome defined as clinical neurological worsening after study enrollment according to the study protocol.
|
From T0 through Day 30
|
|
Incidence of seizures
기간: From T0 through Day 30
|
Safety outcome defined as the occurrence of seizure events after study enrollment.
|
From T0 through Day 30
|
|
Incidence of falls
기간: From T0 through Day 30
|
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
기간: From T0 through Day 30
|
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
기간: From T0 through Day 30
|
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
기간: During the 5-day intervention period
|
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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: QinJian Sun, MD, Shandong Provincial Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 4월 1일
기본 완료 (추정된)
2027년 4월 1일
연구 완료 (추정된)
2027년 6월 1일
연구 등록 날짜
최초 제출
2026년 4월 29일
QC 기준을 충족하는 최초 제출
2026년 5월 8일
처음 게시됨 (실제)
2026년 5월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 8일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
The IPD will be available from Principal Investigators (Prof.
Qinjian Sun) upon reasonable request 6 months after the trial completion.
IPD 공유 기간
IPD will be made available 6 months after the completion of the trial.
IPD 공유 액세스 기준
The IPD can be accessed by Principal Investigators (Prof.
Qinjian Sun) 6 months after the completion of the trial, subject to a reasonable request.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .