Acute Ischemic StrokeSeeBCINCT07585058
Safety and Efficacy of Early Non-invasive Brain-Computer Interface-Based Rehabilitation in Acute Ischemic Stroke
A study testing Real EEG-BCI Training and Standard Early Rehabilitation in people with Acute Ischemic Stroke and Stroke Rehabilitation, run by Shandong Provincial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke, Stroke Rehabilitation
- What is being tested?
- Real EEG-BCI Training and Standard Early Rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy of Early Non-invasive Brain-Computer Interface-Based Rehabilitation Training in Patients With Acute Ischemic Stroke: The SeeBCI Study
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.
Read more
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
- Being tested
- Real EEG-BCI Training, Sham BCI Training, Standard Early Rehabilitation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real EEG-BCI TrainingDevice
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.
Sham BCI TrainingDevice
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.
Standard Early RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: Sham BCI Training; Behavioral: Standard Early Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 30 after randomization
Secondary outcomes (5)
Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) Score
Upper extremity motor function will be assessed using the FMA-UE. The total score ranges from 0 to 66, with higher scores indicating better motor function.
Measured: Baseline, Day 10, Day 30, and Day 90
Action Research Arm Test (ARAT) Score
Upper extremity activity performance will be assessed using the ARAT. The total score ranges from 0 to 57, with higher scores indicating better upper limb functional ability.
Measured: Baseline, Day 30, and Day 90
National Institutes of Health Stroke Scale (NIHSS) Score
Neurological impairment will be assessed using the NIHSS. Scores range from 0 to 42, with higher scores indicating greater neurological deficit.
Measured: Baseline, Day 10, and Day 30
Modified Rankin Scale (mRS) Score
Global functional outcome will be assessed using the modified Rankin Scale. Scores range from 0 to 6, with higher scores indicating greater disability.
Measured: Day 90
Modified Barthel Index (MBI) Score
Activities of daily living will be assessed using the Modified Barthel Index. Higher scores indicate better functional independence.
Measured: Day 30 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- QinJian Sun, MD, Principal investigator, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585058
- Sponsor's protocol ID
- SWYX.NO.2026-1053
- Acronym
- SeeBCI
- Status last verified
- Sep 2026
- First submitted
- 29 Apr 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Early Non-invasive Brain-Computer Interface-Based Rehabilitation Training in Patients With Acute Ischemic Stroke: The SeeBCI Study
- ClinicalTrials.gov ID
- NCT07585058
- Acronym / sponsor ID
- SeeBCI / SWYX.NO.2026-1053
- Conditions
- Acute Ischemic Stroke, Stroke Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Real EEG-BCI Training + Standard Early Rehabilitation | Experimental | Device: Real EEG-BCI Training, Behavioral: Standard Early RehabilitationParticipants 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). |
| Sham BCI Training + Standard Early Rehabilitation | Sham comparator | Device: Sham BCI Training, Behavioral: Standard Early RehabilitationParticipants 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real EEG-BCI TrainingNon-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. | Device | Real EEG-BCI Training + Standard Early Rehabilitation |
| Sham BCI TrainingSham 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. | Device | Sham BCI Training + Standard Early Rehabilitation |
| Standard Early RehabilitationParticipants 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. | Behavioural | Real EEG-BCI Training + Standard Early Rehabilitation, Sham BCI Training + Standard Early Rehabilitation |
Primary outcome
Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) Score From Baseline to Day 30
Time frame: Baseline to Day 30 after randomization
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.
5 secondary outcomes
Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) Score
Time frame: Baseline, Day 10, Day 30, and Day 90
Action Research Arm Test (ARAT) Score
Time frame: Baseline, Day 30, and Day 90
National Institutes of Health Stroke Scale (NIHSS) Score
Time frame: Baseline, Day 10, and Day 30
Modified Rankin Scale (mRS) Score
Time frame: Day 90
Modified Barthel Index (MBI) Score
Time frame: Day 30 and Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
QinJian Sun, MD principal investigator
Shandong Provincial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Real EEG-BCI Training and Standard Early Rehabilitation in people with Acute Ischemic Stroke and Stroke Rehabilitation, run by Shandong Provincial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Chen, MD (+86 531 68773274, chenwang@sph.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) Score From Baseline to Day 30 (time frame: Baseline to Day 30 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.