Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury (NCT00583804) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury
United States10 participantsStarted 1989-04-01
Plain-language summary
The purpose of this study is to evaluate the effectiveness of an implanted stimulator and sensor for providing hand and arm function for individuals with cervical level spinal cord injury.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* C5-C8 spinal cord injury
* Minimum of one-year post injury with no additional function prior to implantation surgery
* Male or female
* 18-60 years of age
* intact vision
* pharmacologically controlled spasticity, when applicable
* Functional in wheelchair with adequate trunk support to allow bimanual manipulation
* Positive attitude and motivation with supportive home environment
* Willingness to return to laboratory for periodic evaluation and testing
* Free of contractures known to diminish performance of the system (e.g., supination contracture of the wrist).
* Integrity of the lower motor neuron (peripheral nerve) to the muscles to be activated
* Adequate range of motion of joints of the shoulder, wrist, and hand (upper extremity).
* If an acute infection is present, the subject will not be considered for surgery until it clears.
Exclusion Criteria:
* Prior history of a major chronic systemic infection or other illness that would increase the risk of surgery.
* Contraindications include immunologic diseases, cardiac arrhythmias, undiagnosed or high-risk breast masses, dermatologic conditions, and any major system failure.
* Acute infection currently present that has not cleared.
* Hypersensitivity that inhibits their ability to sustain pressure over their digits.
* Blind
* Uncontrolled disorders, i.e., seizures