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Brain-Computer interface boosts stroke recovery in early trial

NCT ID NCT07585058

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding brain-computer interface (BCI) training to standard early rehabilitation helps people recover arm and leg movement after an acute ischemic stroke. Sixty adults aged 18 to 80 with one-sided limb weakness will receive either standard rehab alone or standard rehab plus BCI training using virtual hand and gait exercises. The main goal is to see if BCI improves upper-arm function after 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EEG-based non-invasive brain-computer interface (BCI) virtual hand/gait training system
What this could lead to
If it works, this could offer a new way to boost motor recovery early after stroke, potentially improving arm and leg function more than standard rehab alone.
What could go wrong
This is a small early trial with only 60 participants, so results may not apply to all stroke patients. The BCI training is short (5 days), and benefits may be modest or not last.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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