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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT02718768
Eligibility Criteria:
Inclusion Criteria:
1. Ages 18-65
2. Sustained a peripheral nerve injury (including iatrogenic injuries and partial nerve injuries) resulting from upper extremity trauma meeting the following criteria:
1. Involves injury or dysfunction to motor, or motor and sensory function of the axillary, radial, median, ulnar, or musculocutaneous nerve with injury localized distal to the brachial plexus cord level and proximal to the distal flexion crease of the wrist
2. Involves a "mixed" nerve segment (i.e. involves a location of any of the above specified nerves that can be expected to have both sensory and motor axons present) but does not include sensory only distal terminations of the same nerves.
3. Receiving surgical treatment (i.e. exploration, neurolysis, repair or reconstruction, nerve or tendon transfer) within 6 months of the initial injury.
Exclusion Criteria:
1. Injuries to the brachial plexus roots, trunks, divisions and cords
2. Injuries to the nerves distal to the distal flexion crease of the wrist
3. Injuries that involve a distal extension of the parent nerve that is considered sensory only (superficial radial nerve, lateral ante brachial cutaneous nerve, etc)
4. Previous motor or sensory deficit prior to injury (e.g. resulting from trauma, stroke, muscular, neurologic, neuromuscular disorder, etc.)
5. Documented psychiatric disorder that limits ability to consent and maintain follow-up
6. Unable to speak either English or Spanish
7. Severe problems with maintaining follow up (e.g patients who are prisoners or homeless at time of injury or who are intellectually challenged without adequate family support).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02718768
Study Brief:
Protocol Section:
NCT02718768