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NOT YET RECRUITING
NCT07686822
NA

Spinal Cord Stimulation Combined With Motor Imagery Brain-Computer Interface for Chronic Post-Stroke Upper Limb Motor Dysfunction

Sponsor: Zhejiang Provincial People's Hospital

View on ClinicalTrials.gov

Summary

This clinical study aims to evaluate the efficacy and safety of spinal cord stimulation combined with non-invasive motor imagery brain-computer interface rehabilitation training in patients with upper limb motor dysfunction after chronic stroke. The study includes an experimental group receiving spinal cord stimulation combined with motor imagery brain-computer interface rehabilitation training and a control group receiving motor imagery brain-computer interface rehabilitation training alone. The primary outcome is upper limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity. Secondary outcomes include muscle tone, upper limb functional activity, activities of daily living, adverse events, serious adverse events, and exploratory neurophysiological and neuroimaging indicators.

Official title: A Prospective, Single-Center, Non-Randomized, Parallel-Controlled Study to Evaluate the Efficacy and Safety of Spinal Cord Stimulation Combined With Non-Invasive Motor Imagery Brain-Computer Interface Rehabilitation Training for Upper Limb Motor Dysfunction in Patients With Chronic Stroke

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2026-09

Completion Date

2028-05

Last Updated

2026-07-07

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Spinal Cord Stimulation

Spinal cord stimulation will be delivered through epidural electrodes implanted at cervical spinal cord levels, typically C3-C7 for upper limb dysfunction. Stimulation parameters will be individually optimized within clinically safe and device-permitted ranges, including frequency, pulse width, amplitude, electrode configuration, and stimulation mode.

DEVICE

Motor Imagery Brain-Computer Interface Rehabilitation Training

Motor imagery brain-computer interface training will use a 64-channel medical-grade electroencephalography cap to acquire scalp EEG signals. Participants will perform motor imagery tasks involving the affected upper limb, such as grasping, elbow extension, or wrist lifting. Sensorimotor rhythm features, especially mu rhythm and beta rhythm event-related desynchronization, will be extracted in real time. When significant event-related desynchronization is detected, the system will trigger external feedback, such as a soft robotic glove or functional electrical stimulation, to assist the affected limb in completing the target movement.

Locations (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China