RecruitingNot ApplicableNCT07722429

Exploration of the Effectiveness and Mechanism of Personalized Epidural Electrical Stimulation in Improving Upper Limb Function in Participants With Spinal Cord Injury

Sponsor

Buddhist Tzu Chi General Hospital

Enrollment

20 participants

Start Date

Nov 17, 2025

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injury (SCI)

Summary

This study aimed to determine whether cervical spinal cord epidural electrical stimulation (EES) can activate upper-limb muscles in individuals with spinal cord injury.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria8

Age between 18 and 70 years.
Duration since spinal cord injury ranging from 1 to 10 years.
Spinal cord injury level at or above T4.
MRI and/or CT imaging confirms adequate spinal cord decompression and spinal stability.
Stable vital signs and no dependence on mechanical ventilation.
Stable neurological and psychological status, with no history of neurological deterioration within the past 6 months (e.g., acute worsening of motor or sensory function, new-onset seizures, acute changes in muscle tone, or other neurological symptoms). Participants must be conscious, able to understand, and comply with study instructions. Clinical neurological examinations and imaging findings (MRI or CT) should demonstrate no new abnormalities.
Willingness to participate in and comply with rehabilitation programs.
Participants who have completed spinal cord electrical stimulation implantation surgery and/or are currently undergoing conventional rehabilitation therapy.

Exclusion Criteria4

Patients with untreated fractures of the upper extremities.
Patients with severe skin lesions or wounds that interfere with EMG electrode placement or the surgical sites for electrical stimulation implantation (e.g., chest/back, upper extremities, posterior cervical region, or subclavicular area).
Patients with a history of other neurological diseases.
Patients with known allergy or hypersensitivity to silver (Ag).

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Interventions

DEVICEEpidural electrical stimulation (EES)

Subjects will undergo a surgical procedure to implant a system that provides epidural electrical stimulation (EES) of the cervical spinal cord. After surgery, subjects will undergo a structured physical rehabilitation program and electrical stimulation.