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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 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Experimental BCI Rehabilitation Group
Standard early rehabilitation plus early EEG-BCI dual-module virtual hand and gait training
Dispositif: 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.
Comportemental: Standard Early Rehabilitation
Participants receive site-standard early rehabilitation according to the local rehabilitation protocol.
Comparateur actif: Standard Early Rehabilitation Group
Standard early rehabilitation without additional BCI training.
Comportemental: Standard Early Rehabilitation
Participants receive site-standard early rehabilitation according to the local rehabilitation protocol.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Screening-to-enrollment ratio
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Shandong Provincial Hospital

Les enquêteurs

  • Chercheur principal: QinJian Sun, MD, Shandong Provincial Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 avril 2026

Achèvement primaire (Estimé)

1 avril 2027

Achèvement de l'étude (Estimé)

1 juin 2027

Dates d'inscription aux études

Première soumission

29 avril 2026

Première soumission répondant aux critères de contrôle qualité

8 mai 2026

Première publication (Réel)

13 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 mai 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • RT-BCI-2026-0219

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

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

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • ANALYTIC_CODE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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