Spinal Cord Injury(SCI)
Conditions
Brief 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.
Detailed description
This study aims to determine whether epidural electrical stimulation (EES) of the cervical spinal cord can activate arm and hand muscles in patients with spinal cord injury. Participants will undergo surgery to implant a system designed for cervical spinal cord EES. Following surgery, they will engage in structured physical rehabilitation and electrical stimulation therapy. Researchers will quantify the motor potentials in arm and hand muscles evoked by cervical EES, adjust stimulation parameters to optimize the elicitation of arm and hand movements, and assess the participants' upper-limb motor function using standard clinical tests and simple motor tasks.
Interventions
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.
Sponsors
Buddhist Tzu Chi General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in spasticity as measured by the Modified Ashworth Scale (MAS) | Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation | Quantify spasticity scores using the Modified Ashworth Scale (MAS) for the shoulder, elbow, and wrist. The muscle tension is divided into 0-4 grades. The lower the score, the closer to normal. The higher the score, the more severe the spasticity. |
| Change in activities of daily living as measured by the Barthel Index (BI). | Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation | The Barthel Index (BI) assesses functional independence in activities of daily living across 10 domains, including self-care, mobility, and continence. Scores range from 0 to 100, with higher scores indicating greater independence. |
| Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF) | Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation | The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely". , The higher the score, the better the quality of life |
Countries
Taiwan
Contacts
CONTACTSheng-Tzung Tsai, M.D., Ph.D
CONTACTYu-Chen Chen, M.D., Ph.D.
PRINCIPAL_INVESTIGATORSheng-Tzung Tsai, M.D., Ph.D
Hualien Tzu Chi General Hospital
Outcome results
None listed