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Study on the Efficacy and Safety of Brain-Computer Interface Based on Motor Imagery in Promoting the Upper Limb Motor Recovery of Patients with Acute Stroke

Study on the Efficacy and Safety of Brain-Computer Interface Based on Motor Imagery in Promoting the Upper Limb Motor Recovery of Patients with Acute Stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106782
Enrollment
Unknown
Registered
2025-07-30
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Stroke

Interventions

Experimental group:The intervention lasts for 10 days and subjects undergo routine rehabilitation training for BCI. BCI training is based on motor imagery triggered EEG-controlled electrical stimulati
Routine rehabilitation is once a day, including comprehensive hemiplegic limb training, joint mobilization, occupational therapy, hand function training, etc., with each treatment lasting about 30 min

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. First-episode stroke or a history of previous cerebral infarction with a modified Rankin Scale (mRS) score of 0 before the current onset; 2. Aged 40–85 years; 3. Diagnosed with stable ischemic stroke and a Glasgow Coma Scale (GCS) score of 15; 4. Disease duration within 7 days after stroke onset; 5. Presence of upper limb dysfunction with upper limb muscle strength graded 1–4; 6. National Institutes of Health Stroke Scale (NIHSS) score of 2–20 and no prior formal rehabilitation treatment; 7. Mini-Mental State Examination (MMSE) score >= 23; 8. Strong demand for rehabilitation and good family support; 9. Patients voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Large-area cerebral infarction, hemorrhagic infarction, or unstable vital signs; 2. Severe primary diseases of the heart, brain, lungs, liver, kidneys, etc., or malignant tumors; 3. Complications of active epilepsy, limb tremors, or inability to maintain a sitting posture; 4. Upper limb venous thrombosis in hemiplegic patients that makes rehabilitation therapy inappropriate; 5. Severe speech, attention, visual or auditory impairments; 6. Mental or cognitive dysfunction that prevents cooperation with examinations and rehabilitation treatments; 7. Contraindications to functional magnetic resonance imaging, such as having a cardiac pacemaker, metal stents, steel plates, or other metallic foreign bodies implanted in the body; 8. Contraindications to electroencephalogram examination, such as skull defects or artificial metal skulls; 9. Alcoholism or drug addiction; 10. Pregnant women.

Design outcomes

Primary

MeasureTime frame
FMA-upper;

Secondary

MeasureTime frame
Wolf motor function;Manual Muscle (MMT);Modified Ashworth Scale (MAS) Score;mRS Score;

Countries

Chnia

Contacts

Public ContactJing Ding

Zhongshan Hospital, Fudan University

ding.jing@zs-hospital.sh.cn+86 21 6404 1990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026