This study aimed to determine whether cervical spinal cord epidural electrical stimulation (EES) can activate upper-limb muscles in individuals with spinal cord injury.
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.
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).
Single group
Epidural electrical stimulation (EES)
DeviceSubjects 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.
Change in functional independence as measured by the Spinal Cord Independence Measure III (SCIM-III)
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).
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)
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).
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.
Change in spasticity as measured by the Modified Ashworth Scale (MAS)
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).
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)
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
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