Safety and Efficacy of Early Brain-Computer Interface Training After Reperfusion Therapy in Acute Ischemic Stroke (RT-BCI)
8. května 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Typ studie
Intervenční
Zápis (Odhadovaný)
60
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Wang Chen, MD
- Telefonní číslo: +86-68773274
- E-mail: chenwang@sph.com.cn
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Aktivní komparátor: Standard Early Rehabilitation Group
Standard early rehabilitation without additional BCI training.
|
Participants receive site-standard early rehabilitation according to the local rehabilitation protocol.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Screening-to-enrollment ratio
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: QinJian Sun, MD, Shandong Provincial Hospital
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. dubna 2026
Primární dokončení (Odhadovaný)
1. dubna 2027
Dokončení studie (Odhadovaný)
1. června 2027
Termíny zápisu do studia
První předloženo
29. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
8. května 2026
První zveřejněno (Aktuální)
13. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
13. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. května 2026
Naposledy ověřeno
1. dubna 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- RT-BCI-2026-0219
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
The IPD will be available from Principal Investigators (Prof.
Qinjian Sun) upon reasonable request 6 months after the trial completion.
Časový rámec sdílení IPD
IPD will be made available 6 months after the completion of the trial.
Kritéria přístupu pro sdílení IPD
The IPD can be accessed by Principal Investigators (Prof.
Qinjian Sun) 6 months after the completion of the trial, subject to a reasonable request.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .