Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT00583804
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00583804
Study Brief:
Protocol Section:
NCT00583804