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Study on Brain-Computer Interactive Stroke Motor Rehabilitation System and Its Mechanism of Inducing Plastic Recovery of Neural Pathways--A Randomized Controlled Trial of Brain-Computer Interactive Stroke Motor Rehabilitation System in the Treatment of Upper Limb Dysfunction after Stroke

Study on Brain-Computer Interactive Stroke Motor Rehabilitation System and Its Mechanism of Inducing Plastic Recovery of Neural Pathways--A Randomized Controlled Trial of Brain-Computer Interactive Stroke Motor Rehabilitation System in the Treatment of Upper Limb Dysfunction after Stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103983
Enrollment
Unknown
Registered
2025-06-09
Start date
2025-06-15
Completion date
Unknown
Last updated
2025-06-16

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

Conditions

Upper limb dysfunction after stroke

Interventions

EEG control group:The motor intent is decoded by the BCI, and FES feedback is given to the affected limb when the correct motor intent is decoded, and the hand is driven
myoelectric control group:The movement is recognized by the unaffected side EMG, and FES feedback is given to the affected limb when the target movement is recognized, and the hand is driven to open
Passive group:After completing the task, the affected side is given FES feedback at random moments to drive the hand to open
Conventional rehabilitation group:After completing the task, the therapist drives the affected hand to open

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for hemorrhagic stroke or ischemic stroke, and confirmed by cranial computed tomography or magnetic resonance imaging, and the course of the disease is 3 months after the onset of the disease; 2. Unilateral upper limb dysfunction (Fugl-Meyer Upper Limb Motor Function Rating Scale (FMA-UE) = 27 points; 7. All patients can independently understand the purpose of study enrollment, and can independently sign the informed consent form or authorize close relatives to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Unstable vital signs, or combined with other serious systemic diseases, such as severe angina, heart failure, active gastrointestinal bleeding, hemodialysis status, terminal stage of malignant tumors, etc., or have undergone pacemaker implantation and other surgeries that cannot be performed by MRI examination; 2. Combined with other neurological diseases, such as intracranial mass lesions, epilepsy, Parkinson's disease, Parkinson's superimposed disease, Alzheimer's disease, motor neuron disease, myasthenia gravis, AIDP, CIDP, etc.; 3. Inability to maintain sitting for 30 minutes; 4. Those who are not suitable for EEG signal acquisition and electrical stimulation treatment, including: patients who are pregnant; Those with pacemakers; Patients with severe cardiopulmonary dysfunction, shock and water and electrolyte disorders; Those with severe osteoporosis or recent fractures, limb fractures that have not healed; Those with uncontrolled fever and infection; Those who have broken skin on the scalp and the treated area.

Design outcomes

Primary

MeasureTime frame
Functional Movement System - Upper Extremity Screen Score;

Secondary

MeasureTime frame
FES target muscle extensor joint strength score;Wrist Extensor and Flexor Modified Asworth Scale;Surface muscle number;Resting and task brain numbers;Resting and task state magnetic resonance signals;

Countries

China

Contacts

Public ContactZhang Yang

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

zhangyang982003@163.com+86 198 6216 8829

Outcome results

None listed

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