Exploration of the Effectiveness and Mechanism of Personalized Epidural Electrical Stimulation in Improving Upper Limb Function in Participants With Spinal Cord Injury
Epidural 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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).
Primary outcome measure(s)
Change in functional independence as measured by the Spinal Cord Independence Measure III (SCIM-III) — Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation The Spinal Cord Independence Measure III (SCIM-III) is a standardized functional assessment tool specifically designed for individuals with spinal cord injury. It evaluates independence in daily activities, including self-care, respiration and sphincter management, and mobility, to quantify the impact of spinal cord injury on functional ability. The SCIM-III consists of 19 items, Each item is typically scored on a scale ranging from 0 (completely dependent) to 3 (completely independent).with higher scores indicating greater independence in activities of daily living.
Change in ASIA Impairment Scale (AIS) grade assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). — Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) is a standardized assessment of motor and sensory function following spinal cord injury. Neurological impairment is classified using the American Spinal Injury Association (ASIA) Impairment Scale (AIS), which ranges from Grade A (complete injury) to Grade E (normal motor and sensory function). Higher AIS grades indicate better neurological function and less severe neurological impairment.
Change dexterity of the upper limb as measured by the Action Research Arm Test (ARAT) — Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation Use the Action Research Arm Test (ARAT) assessment to quantify functional hand and arm dexterity. The score ranges from 0 to 57, with a higher value indicating better function.
Change in hand dexterity as measured by the Box and Block Test (BBT). — Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation The Box and Block Test (BBT) assesses manual dexterity and upper extremity function by measuring the number of blocks transferred within 60 seconds. Higher scores indicate better hand function and coordination.
Trial sites (1)
Facility
City
Region
Status
Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
Hualien City
Taiwan
Recruiting
More Buddhist Tzu Chi General Hospital trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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