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:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
NCT ID:
NCT02861612
Eligibility Criteria:
Inclusion Criteria:
* Patients with a spinal cord injury AIS level C5 to C7. Those with motor complete injuries (AIS A or B) will be considered for surgical intervention if they are ≥ 5 months post injury. Motor incomplete patients (AIS C or D) will be considered if they are ≥ 1.5 years post injury.
* Patients will require ≥ MRC 4 strength of the muscle supplied by the donor nerve (e.g. brachialis, supinator).
* Finger flexor and extensor strength should be ≤ MRC 1 strength.
* Muscles supplied by the donor nerve, will need to have no or minimal of evidence of lower motor neuron injury as dictated by evidence of fibrillations, positive sharp waves, or moderate or severely decreased recruitment on needle electromyography.
* Those being evaluated for surgery outside nine-months post injury recipient muscles will be required to be free of lower motor neuron pathology.
* Ability to comply and participate in rigorous post-surgical therapy regimen.
Exclusion Criteria:
* Comorbidities precluding safe surgery including autonomic/hemodynamic instability, pulmonary instability, active infection, chronic pressure sores or untreated urinary tract infections as determined by physician.
* Simultaneous tendon transfer or tenodesis surgery (which would preclude separation of the effect of nerve transfer alone).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02861612
Study Brief:
Protocol Section:
NCT02861612