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NOT YET RECRUITING
NCT07903116
NA

Closed-Loop SCS-BCI for Post-Stroke Hemiplegia

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

This study evaluates a new closed-loop rehabilitation system for stroke survivors with arm weakness. The system combines a brain-computer interface (BCI, a special cap that reads brain signals), spinal cord stimulation (a temporary implanted electrode that sends gentle electrical pulses to the spine), and a robotic hand exoskeleton. When the participant imagines moving their affected hand, the system detects this intention from brain signals and immediately triggers the spinal stimulation and robotic assistance to help complete the movement. The goal is to test whether this "brain-spine-hand" closed-loop approach is safe and can improve upper limb function after stroke. About 30 stroke patients with chronic arm weakness will be enrolled. Participants will first undergo brain signal testing to confirm they can produce detectable movement intentions. Eligible participants will then have a temporary spinal cord stimulator electrode placed under the skin near the spine. Over the next 4 weeks, they will receive daily training sessions (about 90 minutes, 5 days per week) using the closed-loop system. After 4 weeks, the electrode will be removed, and participants will continue standard rehabilitation. Hand and arm function will be assessed before, during, and after the intervention.

Official title: Clinical Application Study of Closed-Loop Spinal Cord Stimulation Brain-Computer Interface System for Motor Function Reconstruction in Post-Stroke Limb Hemiplegia

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-09

Completion Date

2028-06

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

DEVICE

Spinal Cord Stimulation

Temporary invasive spinal cord stimulation triggered by motor intention to facilitate neural excitability.

DEVICE

Non-invasive Brain-Computer Interface

Non-invasive EEG-based system for real-time motor intention detection.

DEVICE

Hand Exoskeleton

Robotic exoskeleton guiding affected hand to complete grasping movements, synchronized with decoded motor intention and SCS stimulation.

BEHAVIORAL

Motor Imagery Rehabilitation Training

Closed-loop motor imagery training combining BCI, SCS, and exoskeleton feedback.

Locations (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China