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A Clinical Study on the Therapeutic Effect of Upper Limb Function Rehabilitation Based on Brain-Computer Interface for Stroke Patients

A Clinical Study on the Therapeutic Effect of Upper Limb Function Rehabilitation Based on Brain-Computer Interface for Stroke Patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095329
Enrollment
Unknown
Registered
2025-01-06
Start date
2025-01-10
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Upper limb motor dysfunction after stroke

Interventions

Control Group:Conventional rehabilitation therapy
BCI group:Brain-computer Interface training

Sponsors

Sun Yat sen Memorial Hospital, Sun Yat sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis is in line with the "Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China 2018" and the "Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage in China 2019", and patients with cerebral infarction or cerebral hemorrhage are diagnosed by head CT or MRI; 2. There is limb hemiplegia, 2 weeks <= course of disease <= 12 months; 3. Aged 18-75 years; 4. Clinical scale assessment confirmed arm and hand motor dysfunction, that is, limited autonomous activities; 5. Both arms have intact skin and no sensory disturbances; 6. Vital signs are stable, consciousness is clear, cognitive function is normal, and can cooperate with treatment and assessment; 7. The patient himself or his family members signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those with disorders of consciousness; 2. Those with a history of epilepsy or a first-degree relative with a history of idiopathic epilepsy or the use of epileptogenic drugs; 3. Those with severe aphasia, cognitive impairment, severe depression, or other conditions that prevent them from completing training; 4. Those with skull defects or surgical incisions that affect the fitting of the EEG headband; 5. Those with implanted electronic devices (such as pacemakers); 6. Those with comorbidities that limit patient mobility, such as severe cardiopulmonary diseases or unstable hypertension; 7. Those with severe joint deformities or limited range of motion in the affected limb.

Design outcomes

Primary

MeasureTime frame
Simplified Fugl-Meyer upper limb motor function score;

Secondary

MeasureTime frame
Modified Ashworth scale;Manual Muscle Test;Barthel Index;

Countries

China

Contacts

Public ContactShengnuo Fan

Sun Yat sen Memorial Hospital, Sun Yat sen University

arnoldvan@163.com+86 13570987052

Outcome results

None listed

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