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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT06003166
Eligibility Criteria:
Inclusion Criteria:
* Patients with trauma involving two or less limbs where the continuity of a given peripheral nerve or nerves is unclear on presenting physical examination.
* Closed soft tissue envelope obscuring direct observation of the continuity of the affected nerve.
* Cognitive ability to report sensory and motor deficit during examination.
* Eligible for standard of care plan of monitoring vs surgical exploration of the nerve.
* Adults subject aged 18-90
* Known limb trauma which resulted in nerve injury (aim 1) or post-operative/post intervention nerve injury (aim 2).
* Ability to give written informed consent.
* Availability for all testing days and main trial day.
Exclusion Criteria:
* Distracting injury which prevents adequate examination.
* Plan for surgical exploration of the nerve during the ensuing 48 hours.
* Plan for surgical exploration of the nerve as part of another surgical procedure within 48 hours of evaluation.
* Intoxication during examination or evidence of cognitive deficit that emerges during examination.
* History of multiple sclerosis, stroke or any other diagnosed neurological disorder
* History of hypersensitivity to AMPYRA® or 4-aminopyridine
* Current use of aminopyridine medications, including other compounded 4-AP
* Renal impairment based on calculated GFR (GFR\<80 mL/min). This laboratory value is measured in all inpatient trauma patients as part of the standard of care.
* History of difficult compliance with timely follow up or plan to seek care at another institution closer to home.
* Patients outside the age range or unable to consent.
* Patients with a known history of a seizure disorder (4AP overdose can, in selected cases, result in limited seizure activity).
* Patients with a concomitant traumatic brain injury.
* Patients unable to communicate return or loss of sensation.
* Patients unable to exhibit motor control on the affected limb at baseline.
* Patients unwilling to complete the study requirements.
* Patients with injuries too extensive to isolate a single nerve(s) for testing.
* Patients currently taking organic cat-ion transporter 2 (OCT2) inhibitors, e.g. Cimetidine.
* Pregnancy, breastfeeding or incarcerated individuals.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06003166
Study Brief:
Protocol Section:
NCT06003166