Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07585058

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Standard Early Rehabilitation

Behavioral

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

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

  2. Action Research Arm Test (ARAT) score

    Time frame: 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.

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

    Time frame: 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.

  4. Functional Ambulation Category (FAC) score

    Time frame: Day 10 (±2 days), Day 30, Day 90

    Walking ability assessed using the Functional Ambulation Category. Higher scores indicate greater independence in ambulation.

  5. 10-Meter Walk Test (10MWT) performance

    Time frame: 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.

  6. Timed Up and Go (TUG) test performance

    Time frame: 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.

  7. National Institutes of Health Stroke Scale (NIHSS) score

    Time frame: 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.

  8. Modified Rankin Scale (mRS) score

    Time frame: Day 30, Day 90

    Global disability assessed using the modified Rankin Scale. Lower scores indicate less disability and greater functional independence.

  9. Barthel Index (BI) / Modified Barthel Index (MBI) score

    Time frame: 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.

Other outcomes

  1. Screening-to-enrollment ratio

    Time frame: 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.

  2. Intervention adherence rate

    Time frame: During the 5-day intervention period

    Feasibility outcome defined as the proportion of planned training sessions completed by each participant.

  3. Effective BCI training duration

    Time frame: During the 5-day intervention period

    Feasibility outcome defined as the cumulative duration of valid BCI training completed during the intervention period.

  4. EEG signal quality and classification accuracy

    Time frame: During the 5-day intervention period

    Feasibility outcome assessing the quality of EEG acquisition and the performance of signal classification during BCI training sessions.

  5. Follow-up completion rate

    Time frame: Through Day 90

    Feasibility outcome defined as the proportion of randomized participants who complete scheduled outcome assessments through Day 90.

  6. Protocol deviation rate

    Time frame: From randomization through Day 90

    Feasibility outcome defined as the proportion of participants with one or more protocol deviations.

  7. Incidence of symptomatic intracranial hemorrhage

    Time frame: From T0 through Day 30

    Safety outcome defined as the occurrence of symptomatic intracranial hemorrhage after study enrollment.

  8. Incidence of any intracranial hemorrhage

    Time frame: From T0 through Day 30

    Safety outcome defined as the occurrence of any type of intracranial hemorrhage after study enrollment.

  9. Incidence of neurological deterioration

    Time frame: From T0 through Day 30

    Safety outcome defined as clinical neurological worsening after study enrollment according to the study protocol.

  10. Incidence of seizures

    Time frame: From T0 through Day 30

    Safety outcome defined as the occurrence of seizure events after study enrollment.

  11. Incidence of falls

    Time frame: From T0 through Day 30

    Safety outcome defined as the occurrence of falls during the study period.

  12. Incidence of blood pressure or cardiac rhythm adverse events

    Time frame: From T0 through Day 30

    Safety outcome defined as blood pressure instability or cardiac arrhythmia events occurring during the study period.

  13. Incidence of puncture-site bleeding or hematoma

    Time frame: From T0 through Day 30

    Safety outcome assessed in participants in the MT pathway, defined as puncture-site bleeding or hematoma after mechanical thrombectomy.

  14. Incidence of training-related discomfort

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wang Chen, MD

CONTACT

[email protected]

+86-68773274

Sponsors and collaborators

Lead sponsor

Shandong Provincial Hospital

Other Gov

Registry information

Acronym: RT-BCI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.