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Not yet recruitingNCT07585058SeeBCIUpdated Sep 25, 2026

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

An interventional study of Real EEG-BCI Training and Sham BCI Training in Acute Ischemic Stroke and Stroke Rehabilitation, sponsored by Shandong Provincial Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Shandong Provincial Hospital · Not applicable, Interventional, and Treatment

Updated Sep 25, 2026Start date movedPrimary completion moved+6 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Ischemic Stroke
  • Stroke Rehabilitation

Browse trials for

03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 60 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Shandong Provincial Hospital is the lead sponsor of 61 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Sep 25, 2026. See what changed

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  1. Age 18 to 80 years.
  2. Diagnosis of acute ischemic stroke.
  3. Stroke onset to randomization within 48 to 72 hours.
  4. Meets predefined clinical stability criteria before randomization.
  5. Unilateral upper extremity motor impairment on the dominant-hand side.
  6. Baseline Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) score between 10 and 50.
  7. Pre-stroke modified Rankin Scale (mRS) score ≤2.
  8. Written obtained from the participant or legally authorized representative.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Real EEG-BCI Training + Standard Early Rehabilitation

    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 comparator
    Sham BCI Training + Standard Early Rehabilitation

    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

  • DeviceReal EEG-BCI Training

    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.

  • DeviceSham BCI Training

    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.

  • BehavioralStandard Early Rehabilitation

    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.

06

What researchers measure

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.

    Time frame: Baseline to Day 30 after randomization

Secondary outcomes

  1. 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.

    Time frame: Baseline, Day 10, Day 30, and Day 90

  2. 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.

    Time frame: Baseline, Day 30, and Day 90

  3. 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.

    Time frame: Baseline, Day 10, and Day 30

  4. 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.

    Time frame: Day 90

  5. Modified Barthel Index (MBI) Score

    Activities of daily living will be assessed using the Modified Barthel Index. Higher scores indicate better functional independence.

    Time frame: Day 30 and Day 90

Other outcomes

  1. Training Completion Rate

    Feasibility outcome defined as the proportion of completed EEG-BCI or sham BCI training sessions among the planned 20 sessions.

    Time frame: During the 10-day intervention period

  2. Effective Training Duration

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

    Time frame: During the 10-day intervention period

  3. EEG Signal Quality and BCI Performance Metrics

    Feasibility outcome assessing EEG acquisition quality and available BCI performance metrics, including signal quality and classification accuracy when available.

    Time frame: During the 10-day intervention period

  4. Follow-up completion rate

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

    Time frame: Through Day 90

  5. Protocol deviation rate

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

    Time frame: From randomization through Day 90

  6. Incidence of symptomatic intracranial hemorrhage

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

    Time frame: From baseline through Day 90

  7. Incidence of any intracranial hemorrhage

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

    Time frame: From baseline through Day 90

  8. Incidence of neurological deterioration

    Safety outcome defined as clinically relevant neurological worsening after randomization, such as an increase in NIHSS score of 4 or more points without another clear explanation.

    Time frame: From baseline through Day 90

  9. Incidence of seizures

    Safety outcome defined as the occurrence of seizure events after randomization.

    Time frame: From baseline through Day 90

  10. Incidence of Falls or Injuries

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

    Time frame: From baseline through Day 90

  11. Incidence of Cardiovascular and Vital Sign Events

    Safety outcome defined as the occurrence of clinically relevant blood pressure instability or cardiac arrhythmia events during the study period.

    Time frame: From baseline through Day 90

  12. Incidence of training-related discomfort

    Safety outcome defined as the occurrence of training-related discomfort, including fatigue, headache, dizziness, nausea, skin irritation, or other discomfort associated with the intervention.

    Time frame: During the 10-day intervention period

  13. Incidence of serious adverse events

    Safety outcome defined as the occurrence of serious adverse events (SAEs), including death, life-threatening events, hospitalization or prolongation of hospitalization, persistent or significant disability, or other medically important events.

    Time frame: From baseline through Day 90

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.

Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 12 months is below that.

Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: start Apr 2026 → Oct 2026, primary completion Apr 2027 → Oct 2027 and completion Jun 2027 → Dec 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2026
First posted
May 13, 2026
StartEst.
Oct 2026was Apr 2026
Primary completionEst.
Oct 2027was Apr 2027
CompletionEst.
Dec 2027was Jun 2027
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Apr 2026→Oct 2026
Sep 25, 2026
Primary completion
Apr 2027→Oct 2027
Sep 25, 2026
Study completion
Jun 2027→Dec 2027
Sep 25, 2026
Eligibility
Criteria largely rewritten (21 changes)
What changed in the criteria
  • AddedInclusion Criteria:
  • AddedDiagnosis of acute ischemic stroke.
  • AddedStroke onset to randomization within 48 to 72 hours.
  • AddedMeets predefined clinical stability criteria before randomization.
  • AddedUnilateral upper extremity motor impairment on the dominant-hand side.
  • Edited5.Baseline Fugl-Meyer Assessment forof the Upper Extremity (FMA-UE) score ofbetween 10 toand 50 at T0.
  • Edited6. Pre-stroke modified Rankin Scale (mRS) score <= ≤2.
  • AddedWritten informed consent obtained from the participant or legally authorized representative.
Inclusion criteria
  • Removed2. 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.
  • Removed3. Meets the protocol-defined clinical stability criteria for the corresponding treatment pathway (see Section 4.3).
  • Removed4. Unilateral limb motor dysfunction on the same side as the dominant hand.
  • Removed7. 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
  • Removed1. Imaging-confirmed symptomatic intracranial hemorrhage (sICH), or bleeding risk considered unacceptable by the investigator and requiring a change in treatment strategy.
  • Removed2. 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.
  • Removed3. Severe disturbance of consciousness, severe aphasia or neglect, or significant cognitive impairment that would prevent completion of BCI training tasks or primary outcome assessment.
  • Removed4. 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.
  • Removed5. 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.
  • Removed6. Severe scalp skin damage or infection, or any other condition preventing safe use of the EEG electrode cap.
  • Removed7. Frequent seizures within 7 days before randomization, or seizure risk considered unacceptable by the investigator.
  • Removed8. Pregnancy or breastfeeding.
  • Removed9. 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.
Sep 25, 2026
Interventions
Added Device: Real EEG-BCI Training·Device: Sham BCI Training; removed Device: EEG-based non-invasive brain-computer interface (BCI) virtual hand/gait training system. Arms added: Real EEG-BCI Training + Standard Early Rehabilitation·Sham BCI Training + Standard Early Rehabilitation; arms removed: Experimental BCI Rehabilitation Group·Standard Early Rehabilitation Group
Sep 25, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedChange in Fugl-Meyer Assessment forof the Upper Extremity (FMA-UE) scoreScore From Baseline to Day 30Time frame: Baseline (T0), Day 30 → Baseline to Day 30 after randomization
Sep 25, 2026
Secondary outcomes
9 edited, 5 time frame changed, 2 added, 7 removed, 5 description edited
What changed in the outcomes
  • EditedFugl-Meyer Assessment forof the Upper Extremity (FMA-UE) scoreScoreTime frame: Day 10 (±2 days), Day 30, Day 90 → Baseline, Day 10, Day 30, and Day 90
  • EditedAction Research Arm Test (ARAT) scoreScoreTime frame: Day 10 (±2 days), Day 30, Day 90 → Baseline, Day 30, and Day 90
  • EditedNational Institutes of Health Stroke Scale (NIHSS) scoreScoreTime frame: Day 10 (±2 days), Day 30, Day 90 → Baseline, Day 10, and Day 30
  • EditedModified Rankin Scale (mRS) scoreScoreTime frame: Day 30, Day 90 → Day 90
  • EditedBarthel Index (BI) / Modified Barthel Index (MBI) scoreScoreTime frame: Day 10 (±2 days), Day 30, Day 90 → Day 30 and Day 90
  • RemovedFugl-Meyer Assessment for Lower Extremity (FMA-LE) scoreTime frame: Day 10 (±2 days), Day 30, Day 90
  • RemovedFunctional Ambulation Category (FAC) scoreTime frame: Day 10 (±2 days), Day 30, Day 90
  • Removed10-Meter Walk Test (10MWT) performanceTime frame: Day 10 (±2 days), Day 30, Day 90
  • RemovedTimed Up and Go (TUG) test performanceTime frame: Day 10 (±2 days), Day 30, Day 90
  • Editedother outcomeEffective BCI training durationTraining DurationTime frame: During the 5-day intervention period → During the 10-day intervention period
  • Editedother outcomeEEG signal qualitySignal Quality and classification accuracyBCI Performance MetricsTime frame: During the 5-day intervention period → During the 10-day intervention period
  • Editedother outcomeIncidence of fallsFalls or InjuriesTime frame: From T0 through Day 30 → From baseline through Day 90
  • Editedother outcomeIncidence of blood pressure or cardiac rhythmserious adverse eventsTime frame: From T0 through Day 30 → From baseline through Day 90
  • Addedother outcomeTraining Completion RateTime frame: During the 10-day intervention period
  • Addedother outcomeIncidence of Cardiovascular and Vital Sign EventsTime frame: From baseline through Day 90
  • Removedother outcomeScreening-to-enrollment ratioTime frame: Through completion of recruitment, an estimated 16 months
  • Removedother outcomeIntervention adherence rateTime frame: During the 5-day intervention period
  • Removedother outcomeIncidence of puncture-site bleeding or hematomaTime frame: From T0 through Day 30
  • Time frameother outcomeIncidence of symptomatic intracranial hemorrhageFrom T0 through Day 30 → From baseline through Day 90
  • Time frameother outcomeIncidence of any intracranial hemorrhageFrom T0 through Day 30 → From baseline through Day 90
  • Time frameother outcomeIncidence of neurological deteriorationFrom T0 through Day 30 → From baseline through Day 90
  • Time frameother outcomeIncidence of seizuresFrom T0 through Day 30 → From baseline through Day 90
  • Time frameother outcomeIncidence of training-related discomfortDuring the 5-day intervention period → During the 10-day intervention period
  • Descriptionother outcomeIncidence of any intracranial hemorrhage: how it is measured was reworded
  • Descriptionother outcomeIncidence of neurological deterioration: how it is measured was reworded
  • Descriptionother outcomeIncidence of seizures: how it is measured was reworded
  • Descriptionother outcomeIncidence of symptomatic intracranial hemorrhage: how it is measured was reworded
  • Descriptionother outcomeIncidence of training-related discomfort: how it is measured was reworded
Sep 25, 2026
Contact
Study contact's phone or email changed: •••3274→•••3274. See the current contact
Sep 25, 2026
Title
Safety and Efficacy of Early Non-invasive Brain-Computer Interface Training After Reperfusion Therapy-Based Rehabilitation in Acute Ischemic Stroke
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Start date Apr 2026→Oct 2026
    Primary completion Apr 2027→Oct 2027
    Study completion Jun 2027→Dec 2027
    Eligibility Criteria largely rewritten (21 changes)
    What changed in the criteria
    • AddedInclusion Criteria:
    • AddedDiagnosis of acute ischemic stroke.
    • AddedStroke onset to randomization within 48 to 72 hours.
    • AddedMeets predefined clinical stability criteria before randomization.
    • AddedUnilateral upper extremity motor impairment on the dominant-hand side.
    • Edited5.Baseline Fugl-Meyer Assessment forof the Upper Extremity (FMA-UE) score ofbetween 10 toand 50 at T0.
    • Edited6. Pre-stroke modified Rankin Scale (mRS) score <= ≤2.
    • AddedWritten informed consent obtained from the participant or legally authorized representative.
    Inclusion criteria
    • Removed2. 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.
    • Removed3. Meets the protocol-defined clinical stability criteria for the corresponding treatment pathway (see Section 4.3).
    • Removed4. Unilateral limb motor dysfunction on the same side as the dominant hand.
    • Removed7. 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
    • Removed1. Imaging-confirmed symptomatic intracranial hemorrhage (sICH), or bleeding risk considered unacceptable by the investigator and requiring a change in treatment strategy.
    • Removed2. 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.
    • Removed3. Severe disturbance of consciousness, severe aphasia or neglect, or significant cognitive impairment that would prevent completion of BCI training tasks or primary outcome assessment.
    • Removed4. 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.
    • Removed5. 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.
    • Removed6. Severe scalp skin damage or infection, or any other condition preventing safe use of the EEG electrode cap.
    • Removed7. Frequent seizures within 7 days before randomization, or seizure risk considered unacceptable by the investigator.
    • Removed8. Pregnancy or breastfeeding.
    • Removed9. 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.
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedChange in Fugl-Meyer Assessment forof the Upper Extremity (FMA-UE) scoreScore From Baseline to Day 30Time frame: Baseline (T0), Day 30 → Baseline to Day 30 after randomization
    Secondary outcomes 9 edited, 5 time frame changed, 2 added, 7 removed, 5 description edited
    What changed in the outcomes
    • EditedFugl-Meyer Assessment forof the Upper Extremity (FMA-UE) scoreScoreTime frame: Day 10 (±2 days), Day 30, Day 90 → Baseline, Day 10, Day 30, and Day 90
    • EditedAction Research Arm Test (ARAT) scoreScoreTime frame: Day 10 (±2 days), Day 30, Day 90 → Baseline, Day 30, and Day 90
    • EditedNational Institutes of Health Stroke Scale (NIHSS) scoreScoreTime frame: Day 10 (±2 days), Day 30, Day 90 → Baseline, Day 10, and Day 30
    • EditedModified Rankin Scale (mRS) scoreScoreTime frame: Day 30, Day 90 → Day 90
    • EditedBarthel Index (BI) / Modified Barthel Index (MBI) scoreScoreTime frame: Day 10 (±2 days), Day 30, Day 90 → Day 30 and Day 90
    • RemovedFugl-Meyer Assessment for Lower Extremity (FMA-LE) scoreTime frame: Day 10 (±2 days), Day 30, Day 90
    • RemovedFunctional Ambulation Category (FAC) scoreTime frame: Day 10 (±2 days), Day 30, Day 90
    • Removed10-Meter Walk Test (10MWT) performanceTime frame: Day 10 (±2 days), Day 30, Day 90
    • RemovedTimed Up and Go (TUG) test performanceTime frame: Day 10 (±2 days), Day 30, Day 90
    • Editedother outcomeEffective BCI training durationTraining DurationTime frame: During the 5-day intervention period → During the 10-day intervention period
    • Editedother outcomeEEG signal qualitySignal Quality and classification accuracyBCI Performance MetricsTime frame: During the 5-day intervention period → During the 10-day intervention period
    • Editedother outcomeIncidence of fallsFalls or InjuriesTime frame: From T0 through Day 30 → From baseline through Day 90
    • Editedother outcomeIncidence of blood pressure or cardiac rhythmserious adverse eventsTime frame: From T0 through Day 30 → From baseline through Day 90
    • Addedother outcomeTraining Completion RateTime frame: During the 10-day intervention period
    • Addedother outcomeIncidence of Cardiovascular and Vital Sign EventsTime frame: From baseline through Day 90
    • Removedother outcomeScreening-to-enrollment ratioTime frame: Through completion of recruitment, an estimated 16 months
    • Removedother outcomeIntervention adherence rateTime frame: During the 5-day intervention period
    • Removedother outcomeIncidence of puncture-site bleeding or hematomaTime frame: From T0 through Day 30
    • Time frameother outcomeIncidence of symptomatic intracranial hemorrhageFrom T0 through Day 30 → From baseline through Day 90
    • Time frameother outcomeIncidence of any intracranial hemorrhageFrom T0 through Day 30 → From baseline through Day 90
    • Time frameother outcomeIncidence of neurological deteriorationFrom T0 through Day 30 → From baseline through Day 90
    • Time frameother outcomeIncidence of seizuresFrom T0 through Day 30 → From baseline through Day 90
    • Time frameother outcomeIncidence of training-related discomfortDuring the 5-day intervention period → During the 10-day intervention period
    • Descriptionother outcomeIncidence of any intracranial hemorrhage: how it is measured was reworded
    • Descriptionother outcomeIncidence of neurological deterioration: how it is measured was reworded
    • Descriptionother outcomeIncidence of seizures: how it is measured was reworded
    • Descriptionother outcomeIncidence of symptomatic intracranial hemorrhage: how it is measured was reworded
    • Descriptionother outcomeIncidence of training-related discomfort: how it is measured was reworded
    Interventions Added Device: Real EEG-BCI Training·Device: Sham BCI Training; removed Device: EEG-based non-invasive brain-computer interface (BCI) virtual hand/gait training system. Arms added: Real EEG-BCI Training + Standard Early Rehabilitation·Sham BCI Training + Standard Early Rehabilitation; arms removed: Experimental BCI Rehabilitation Group·Standard Early Rehabilitation Group
    Contact Study contact's phone or email changed: •••3274→•••3274. See the current contact
    Title Safety and Efficacy of Early Non-invasive Brain-Computer Interface Training After Reperfusion Therapy-Based Rehabilitation in Acute Ischemic Stroke
    + 6 other changes: verification date, oversight details, description, conditions, design details and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07585058
Lead sponsor
Shandong Provincial Hospital
Responsible party
Sponsor
First posted
May 13, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Wang Chen, MD
Contact
chenwang@sph.com.cn
+86 531 68773274
QinJian Sun, MD
principal investigator · Shandong Provincial Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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