Safety and Efficacy of Early Brain-Computer Interface Training After Reperfusion Therapy in Acute Ischemic Stroke (RT-BCI)
2026年5月8日 更新者：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.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Wang Chen, MD
- 電話番号：+86-68773274
- メール：chenwang@sph.com.cn
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
アクティブコンパレータ：Standard Early Rehabilitation Group
Standard early rehabilitation without additional BCI training.
|
Participants receive site-standard early rehabilitation according to the local rehabilitation protocol.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
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Day 10 (±2 days), Day 30, Day 90
|
|
National Institutes of Health Stroke Scale (NIHSS) score
時間枠：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.
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Day 10 (±2 days), Day 30, Day 90
|
|
Modified Rankin Scale (mRS) score
時間枠：Day 30, Day 90
|
Global disability assessed using the modified Rankin Scale.
Lower scores indicate less disability and greater functional independence.
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Day 30, Day 90
|
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Barthel Index (BI) / Modified Barthel Index (MBI) score
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Screening-to-enrollment ratio
時間枠：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
時間枠：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
|
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Effective BCI training duration
時間枠：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
|
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EEG signal quality and classification accuracy
時間枠：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
|
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Follow-up completion rate
時間枠：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
時間枠：From randomization through Day 90
|
Feasibility outcome defined as the proportion of participants with one or more protocol deviations.
|
From randomization through Day 90
|
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Incidence of symptomatic intracranial hemorrhage
時間枠：From T0 through Day 30
|
Safety outcome defined as the occurrence of symptomatic intracranial hemorrhage after study enrollment.
|
From T0 through Day 30
|
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Incidence of any intracranial hemorrhage
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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Incidence of puncture-site bleeding or hematoma
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：QinJian Sun, MD、Shandong Provincial Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年4月1日
一次修了 (推定)
2027年4月1日
研究の完了 (推定)
2027年6月1日
試験登録日
最初に提出
2026年4月29日
QC基準を満たした最初の提出物
2026年5月8日
最初の投稿 (実際)
2026年5月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月13日
QC基準を満たした最後の更新が送信されました
2026年5月8日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
The IPD will be available from Principal Investigators (Prof.
Qinjian Sun) upon reasonable request 6 months after the trial completion.
IPD 共有時間枠
IPD will be made available 6 months after the completion of the trial.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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米国FDA規制医薬品の研究
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米国FDA規制機器製品の研究
いいえ
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