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

8. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Experimental BCI Rehabilitation Group
Standard early rehabilitation plus early EEG-BCI dual-module virtual hand and gait training
Gerät: 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.
Verhalten: Standard Early Rehabilitation
Participants receive site-standard early rehabilitation according to the local rehabilitation protocol.
Aktiver Komparator: Standard Early Rehabilitation Group
Standard early rehabilitation without additional BCI training.
Verhalten: Standard Early Rehabilitation
Participants receive site-standard early rehabilitation according to the local rehabilitation protocol.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Screening-to-enrollment ratio
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Shandong Provincial Hospital

Ermittler

  • Hauptermittler: QinJian Sun, MD, Shandong Provincial Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. April 2026

Primärer Abschluss (Geschätzt)

1. April 2027

Studienabschluss (Geschätzt)

1. Juni 2027

Studienanmeldedaten

Zuerst eingereicht

29. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Mai 2026

Zuerst gepostet (Tatsächlich)

13. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Mai 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • RT-BCI-2026-0219

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

The IPD will be available from Principal Investigators (Prof. Qinjian Sun) upon reasonable request 6 months after the trial completion.

IPD-Sharing-Zeitrahmen

IPD will be made available 6 months after the completion of the trial.

IPD-Sharing-Zugriffskriterien

The IPD can be accessed by Principal Investigators (Prof. Qinjian Sun) 6 months after the completion of the trial, subject to a reasonable request.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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