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

NCT07686822 | Not Yet Recruiting

• 1 other identifier: KY2026089
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Stroke

Keywords

Stroke rehabilitation; Upper limb motor dysfunction; Spinal cord stimulation; Motor imagery brain-computer interface; Brain-computer interface; Neuromodulation; Neuroplasticity; Upper limb rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Fugl-Meyer Assessment for Upper Extremity Score

  The Fugl-Meyer Assessment for Upper Extremity will be used to evaluate motor function recovery of the affected upper limb.

  Baseline, Week 4, Week 8, and Week 12

Secondary Outcomes (4)

• Change in Modified Ashworth Scale Score

  Baseline, Week 4, Week 8, and Week 12

• Change in Action Research Arm Test Score

  Baseline, Week 4, Week 8, and Week 12

• Change in Modified Barthel Index Score

  Baseline, Week 4, Week 8, and Week 12

• Incidence of Adverse Events and Serious Adverse Events

  From enrollment to Week 12

Other Outcomes (2)

• Change in Electroencephalographic Indicators

  Baseline, Week 4, and Week 12

• Change in Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging Indicators

  Baseline and Week 12

Study Arms (2)

Spinal Cord Stimulation Combined With Motor Imagery Brain-Computer Interface Training

EXPERIMENTAL

Participants in this group will undergo spinal cord stimulation implantation followed by individualized stimulation programming. After stabilization of stimulation parameters, participants will receive standardized motor imagery brain-computer interface rehabilitation training for 4 weeks, 5 sessions per week.

Device: Spinal Cord Stimulation; Device: Motor Imagery Brain-Computer Interface Rehabilitation Training

Motor Imagery Brain-Computer Interface Rehabilitation Training

ACTIVE COMPARATOR

Participants in this group will receive the same frequency and duration of standardized motor imagery brain-computer interface rehabilitation training as the experimental group, for 4 weeks, 5 sessions per week. Training equipment, motor imagery tasks, and feedback methods will be consistent with those used in the experimental group.

Device: Motor Imagery Brain-Computer Interface Rehabilitation Training

Interventions

Spinal Cord Stimulation DEVICE

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.

Spinal Cord Stimulation Combined With Motor Imagery Brain-Computer Interface Training

Motor Imagery Brain-Computer Interface Rehabilitation Training DEVICE

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.

Motor Imagery Brain-Computer Interface Rehabilitation Training; Spinal Cord Stimulation Combined With Motor Imagery Brain-Computer Interface Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years.
• First-ever unilateral supratentorial stroke, either ischemic or hemorrhagic, confirmed by computed tomography or magnetic resonance imaging, resulting in hemiparesis, with disease duration longer than 6 months.
• At least one active movement in the wrist or fingers of the affected upper limb, with muscle strength of grade 1 or higher.
• Fugl-Meyer Assessment for Upper Extremity score between 10 and 40, indicating moderate upper limb motor impairment.
• Change in Fugl-Meyer Assessment score less than 10% within the previous month, indicating a functional plateau.
• Clear consciousness and basically normal cognitive function, with Mini-Mental State Examination score of 24 or higher.
• Stable clinical condition and ability to understand and cooperate with simple instructions and rehabilitation training.
• Written informed consent voluntarily signed by the participant or legal guardian.

You may not qualify if:

• Other neurological diseases that may cause motor dysfunction, such as Parkinson's disease, multiple sclerosis, or spinal cord injury.
• Severe visual or auditory impairment that prevents cooperation with visual or auditory feedback instructions of the brain-computer interface system.
• Contraindications to spinal cord stimulation surgery, such as severe coagulation dysfunction, infection at the puncture site, severe spinal deformity, or spinal canal stenosis.
• History of epilepsy, intracranial metal implants, cardiac pacemaker, or other contraindications to magnetic resonance imaging.
• Previous neuromodulation surgery for hemiparesis, such as spinal cord stimulation or deep brain stimulation.
• Pregnancy or lactation.
• Any other condition judged by the investigator to make the participant unsuitable for this study.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

MeSH Terms

Interventions

Spinal Cord Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Faliang Gao, PhD

CONTACT

+86-571-85893451; gaofaliang1985@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)