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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123548
Enrollment
Unknown
Registered
2026-04-27
Start date
2026-04-27
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Interventions

Control group :Standard early rehabilitation (equal-duration conventional training or conventional rehabilitation education, according to the unified protocol of the research center)
Experimental group :Standard Early Rehabilitation Combined with BCI Training

Sponsors

Shandong Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Ages 18–80; 2. Diagnosed with AIS and received reperfusion therapy (IVT and/or MT); if MT was performed, successful recanalization confirmed intraoperatively: eTICI 2b–3; 3. Satisfy the stability determination of the corresponding path; 4. Dominant hand ipsilateral unilateral limb dysfunction; 5. At time T0, FMA-UE scores 10–50 points (excluding overly light/heavy ceiling or floor effects, to ensure training is measurable and feasible); 6. Pre-stroke mRS <=2; 7. Sign the informed consent and be able to cooperate with training and follow-up (signed by a legal guardian if necessary);

Exclusion criteria

Exclusion criteria: 1. Imaging confirms symptomatic intracranial hemorrhage (sICH) or the investigator determines that the risk of hemorrhage is unacceptable and treatment strategy needs to be changed; 2. Obvious progressive neurological deterioration or requiring urgent intervention (e.g., NIHSS increased by =4 compared to before and the cause is unknown/unstable), not suitable for training; 3. Severe consciousness disorder, serious aphasia/neglect, or significant cognitive impairment, leading to inability to complete BCI training tasks or inability to complete primary outcome assessments; 4. Significant bilateral motor impairment (such as brainstem/bilateral lesions) or previous moderate to severe disability in the contralateral upper/lower limb, affecting training and scale interpretation within the 'unilateral involvement' framework; 5. Severe comorbidities or unstable vital signs (including but not limited to: unstable arrhythmias, severe heart failure/respiratory failure, active severe infection/sepsis, severe liver and kidney failure, etc.), where the investigator judges that it is not safe to complete training and follow-up. 6. Severe scalp skin damage/infection or other reasons preventing safe wearing of an EEG electrode cap; 7. Frequent seizures within the past 7 days randomly, or the investigator deems the risk of epilepsy unacceptable; 8. Pregnancy or breastfeeding; 9. Currently participating in other interventional clinical studies that may affect the outcomes of this study, or deemed unsuitable for enrollment by the investigator;

Design outcomes

Primary

MeasureTime frame
?FMA-UE;

Secondary

MeasureTime frame
upper limb function;National Institutes of Health Stroke Scale;modified Rankin Scale;

Countries

China

Contacts

Public ContactQinjian Sun

Shandong Provincial Hospital

sqj1210@163.com+86 531 68773275

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026