NCT Number: NCT07585058
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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 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.
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.
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.
Time frame: Baseline, Day 10, Day 30, and Day 90
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 30, and Day 90
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 10, and Day 30
Neurological impairment will be assessed using the NIHSS. Scores range from 0 to 42, with higher scores indicating greater neurological deficit.
Time frame: Day 90
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 30 and Day 90
Activities of daily living will be assessed using the Modified Barthel Index. Higher scores indicate better functional independence.
Time frame: During the 10-day intervention period
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
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
Feasibility outcome assessing EEG acquisition quality and available BCI performance metrics, including signal quality and classification accuracy when available.
Time frame: Through Day 90
Feasibility outcome defined as the proportion of randomized participants who complete scheduled outcome assessments through Day 90.
Time frame: From randomization through Day 90
Feasibility outcome defined as the proportion of participants with one or more protocol deviations.
Time frame: From baseline through Day 90
Safety outcome defined as the occurrence of symptomatic intracranial hemorrhage after randomization.
Time frame: From baseline through Day 90
Safety outcome defined as the occurrence of any type of intracranial hemorrhage after randomization.
Time frame: From baseline through Day 90
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
Safety outcome defined as the occurrence of seizure events after randomization.
Time frame: From baseline through Day 90
Safety outcome defined as the occurrence of falls during the study period.
Time frame: From baseline through Day 90
Safety outcome defined as the occurrence of clinically relevant blood pressure instability or cardiac arrhythmia events during the study period.
Time frame: During the 10-day intervention period
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: From baseline through Day 90
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.
Trial opening soon.
Get NotifiedShandong Provincial Hospital
Other Gov
Safety and Efficacy of Early Non-invasive Brain-Computer Interface-Based Rehabilitation Training in Patients With Acute Ischemic Stroke: The SeeBCI Study
Acronym: SeeBCI
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.
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