Safety and Efficacy of Early Non-invasive Brain-Computer Interface-Based Rehabilitation in Acute Ischemic Stroke

NCT07585058 | Not Yet Recruiting

• 1 other identifier: SWYX.NO.2026-1053
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-center, prospective, randomized, sham-controlled pilot clinical study designed to evaluate the efficacy, safety, and feasibility of early non-invasive electroencephalography-based brain-computer interface (EEG-BCI) rehabilitation training in patients with acute ischemic stroke. Eligible participants are adults aged 18 to 80 years with acute ischemic stroke, unilateral upper extremity motor impairment on the dominant-hand side, a baseline Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) score of 10 to 50, and confirmed clinical stability 48 to 72 hours after stroke onset. Participants will be randomly assigned in a 1:1 ratio to receive either real EEG-BCI training plus standard early rehabilitation or sham BCI training plus standard early rehabilitation. Both groups will receive 10 days of training, with two sessions per day and approximately 30 minutes per session. The primary outcome is the change in FMA-UE score from baseline to 30 days after randomization. Secondary outcomes include changes in FMA-UE, Action Research Arm Test (ARAT), National Institutes of Health Stroke Scale (NIHSS), Modified Barthel Index (MBI), and modified Rankin Scale (mRS). Safety outcomes include symptomatic intracranial hemorrhage, any intracranial hemorrhage, neurological deterioration, seizures, falls, cardiovascular events, and training-related adverse events. This pilot study aims to provide preliminary evidence regarding the feasibility, safety, and potential efficacy of early EEG-BCI rehabilitation after acute ischemic stroke and to inform the design of future multicenter randomized controlled trials.

Conditions

Acute Ischemic Stroke; Stroke Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) Score From Baseline to Day 30

  The primary outcome is the change in FMA-UE score from baseline (T0) to 30 days after randomization. The FMA-UE evaluates upper extremity motor function after stroke, with scores ranging from 0 to 66. Higher scores indicate better upper extremity motor function. Change score is calculated as the FMA-UE score at Day 30 minus the baseline FMA-UE score.

  Baseline to Day 30 after randomization

Secondary Outcomes (5)

• Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) Score

  Baseline, Day 10, Day 30, and Day 90

• Action Research Arm Test (ARAT) Score

  Baseline, Day 30, and Day 90

• National Institutes of Health Stroke Scale (NIHSS) Score

  Baseline, Day 10, and Day 30

• Modified Rankin Scale (mRS) Score

  Day 90

• Modified Barthel Index (MBI) Score

  Day 30 and Day 90

Other Outcomes (13)

• Training Completion Rate

  During the 10-day intervention period

• Effective Training Duration

  During the 10-day intervention period

• EEG Signal Quality and BCI Performance Metrics

  During the 10-day intervention period

Study Arms (2)

Real EEG-BCI Training + Standard Early Rehabilitation

EXPERIMENTAL

Participants will receive real electroencephalography-based brain-computer interface (EEG-BCI) training combined with standard early rehabilitation. The EEG-BCI training uses upper extremity motor imagery or motor attempt tasks with real-time decoding of motor intention and virtual hand feedback. Training will be performed twice daily for approximately 30 minutes per session over 10 consecutive days (20 sessions in total).

Device: Real EEG-BCI Training; Behavioral: Standard Early Rehabilitation

Sham BCI Training + Standard Early Rehabilitation

SHAM COMPARATOR

Participants will receive sham BCI training combined with standard early rehabilitation. The sham procedure will match the real EEG-BCI training in appearance, frequency, duration, and workflow, but the feedback will not be generated by real-time EEG-based motor intention decoding. Training will be performed twice daily for approximately 30 minutes per session over 10 consecutive days (20 sessions in total).

Device: Sham BCI Training; Behavioral: Standard Early Rehabilitation

Interventions

Standard Early Rehabilitation BEHAVIORAL

Participants in both groups will receive standard early rehabilitation according to clinical practice, including appropriate physical therapy, occupational therapy, task-oriented training, positioning, and other routine rehabilitation interventions.

Real EEG-BCI Training + Standard Early Rehabilitation; Sham BCI Training + Standard Early Rehabilitation

Real EEG-BCI Training DEVICE

Non-invasive EEG-based brain-computer interface training combined with standard early rehabilitation. The intervention includes EEG signal acquisition, motor intention decoding, and real-time virtual hand feedback. Participants perform upper extremity motor imagery or motor attempt tasks. Training is delivered twice daily for approximately 30 minutes per session for 10 consecutive days.

Real EEG-BCI Training + Standard Early Rehabilitation

Sham BCI Training DEVICE

Sham BCI training designed to maintain participant masking. The procedure matches real EEG-BCI training in device setup, training environment, frequency, duration, and workflow, but the feedback is not linked to the participant's real-time EEG motor intention decoding.

Sham BCI Training + Standard Early Rehabilitation

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.
• Diagnosis of acute ischemic stroke.
• Stroke onset to randomization within 48 to 72 hours.
• Meets predefined clinical stability criteria before randomization.
• Unilateral upper extremity motor impairment on the dominant-hand side.
• Baseline Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) score between 10 and 50.
• Pre-stroke modified Rankin Scale (mRS) score ≤2.
• Written informed consent obtained from the participant or legally authorized representative.

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

+86 531 68773274; chenwang@sph.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be masked to treatment allocation. The intervention operators cannot be masked because they are required to perform EEG-BCI or sham BCI procedures. Intervention operators will not participate in outcome assessments or statistical analyses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either real EEG-BCI training plus standard early rehabilitation or sham BCI training plus standard early rehabilitation. The study uses a parallel-group, sham-controlled pilot randomized design.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 13, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share