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

NCT07585058 | Not Yet Recruiting

• 1 other identifier: RT-BCI-2026-0219
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score

  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

Secondary Outcomes (9)

• Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score

  Day 10 (±2 days), Day 30, Day 90

• Action Research Arm Test (ARAT) score

  Day 10 (±2 days), Day 30, Day 90

• Fugl-Meyer Assessment for Lower Extremity (FMA-LE) score

  Day 10 (±2 days), Day 30, Day 90

• Functional Ambulation Category (FAC) score

  Day 10 (±2 days), Day 30, Day 90

• 10-Meter Walk Test (10MWT) performance

  Day 10 (±2 days), Day 30, Day 90

Other Outcomes (14)

• Screening-to-enrollment ratio

  Through completion of recruitment, an estimated 16 months

• Intervention adherence rate

  During the 5-day intervention period

• Effective BCI training duration

  During the 5-day intervention period

Study Arms (2)

Experimental BCI Rehabilitation Group

EXPERIMENTAL

Standard early rehabilitation plus early EEG-BCI dual-module virtual hand and gait training

Device: EEG-based non-invasive brain-computer interface (BCI) virtual hand/gait training system; Behavioral: Standard Early Rehabilitation

Standard Early Rehabilitation Group

ACTIVE COMPARATOR

Standard early rehabilitation without additional BCI training.

Behavioral: Standard Early Rehabilitation

Interventions

Standard Early Rehabilitation BEHAVIORAL

Participants receive site-standard early rehabilitation according to the local rehabilitation protocol.

Experimental BCI Rehabilitation Group; Standard Early Rehabilitation Group

EEG-based non-invasive brain-computer interface (BCI) virtual hand/gait training system DEVICE

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.

Experimental BCI Rehabilitation Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18 to 80 years.
• \. 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.
• \. Meets the protocol-defined clinical stability criteria for the corresponding treatment pathway (see Section 4.3).
• \. Unilateral limb motor dysfunction on the same side as the dominant hand.
• \. Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score of 10 to 50 at T0.
• \. Pre-stroke modified Rankin Scale (mRS) score \<= 2.
• \. 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.

You may not qualify if:

• \. Imaging-confirmed symptomatic intracranial hemorrhage (sICH), or bleeding risk considered unacceptable by the investigator and requiring a change in treatment strategy.
• \. 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.
• \. Severe disturbance of consciousness, severe aphasia or neglect, or significant cognitive impairment that would prevent completion of BCI training tasks or primary outcome assessment.
• \. 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.
• \. 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.
• \. Severe scalp skin damage or infection, or any other condition preventing safe use of the EEG electrode cap.
• \. Frequent seizures within 7 days before randomization, or seizure risk considered unacceptable by the investigator.
• \. Pregnancy or breastfeeding.
• \. 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.

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• QinJian Sun, MD

  Shandong Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Chen, MD

CONTACT

+86-68773274; chenwang@sph.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will be made available 6 months after the completion of the trial.
• Access Criteria: The IPD can be accessed by Principal Investigators (Prof. Qinjian Sun) 6 months after the completion of the trial, subject to a reasonable request.