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Study on the Mechanism of Closed-loop Brain-Computer Interfaces on Spasticity in Subacute Stroke Patients

Study on the Mechanism of Closed-loop Brain-Computer Interfaces on Spasticity in Subacute Stroke Patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093981
Enrollment
Unknown
Registered
2024-12-16
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Stroke

Interventions

Closed-loop brain-computer interface rehabilitation training group:Traditional rehabilitation therapy + closed-loop brain-computer interface rehabilitation training
Traditional rehabilitation group:Traditional rehabilitation therapy

Sponsors

Shenzhen Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: The patients were diagnosed as cerebral infarction or cerebral hemorrhage by head CT or MRI in accordance with the diagnostic criteria of the fourth National Cerebral Vascular Disease Academic conference in 1995. 1. First-episode stroke patients of both sexes, aged 18-70 years, with unilateral motor dysfunction; The vital signs were stable and could be safely evaluated and treated by neurologist. 2. The onset time ranged from 1 week to 6 months; 3. clear consciousness, no severe cognitive impairment,MMSE (Mini-Mental State Examination score) >20, can cooperate with EEG ERP, motor function evaluation; 4. Experimental study on the ability to tolerate 1-2 hours of sitting balance.

Exclusion criteria

Exclusion criteria: 1. Medical diseases such as heart failure, respiratory failure and severe pulmonary infection may affect the experimental researchers; 2. Drug-uncontrolled hypertension (mean systolic blood pressure >=140 mmHg or mean diastolic blood pressure >=90 mmHg, measured within 7 days); 3. Previous history of mental illness or taking antipsychotic drugs.

Design outcomes

Primary

MeasureTime frame
Ashworth score of upper extremity;

Secondary

MeasureTime frame
Upper Extremity Fugl-Meyer Scale;ADL Assessment Scale;Electroencephalogram (EEG), electromyography (EMG) and cortical-muscle coherence (cortical-muscle coherence) were evaluated;

Countries

China

Contacts

Public ContactLi Hai

Shenzhen Hospital, Southern Medical University

lihai2018@smu.edu.cn+86 137 1461 7721

Outcome results

None listed

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