Pharmaco-Diagnostic Crossover Trial for Peripheral Nerve Continuity After Trauma
University of Arizona
Summary
The purpose of this study is to evaluate the role of single dose 4-aminopyridine (4-AP) on the diagnosis of severing vs non-severing nerve injury after peripheral nerve traction and/or crush injury. The investigational treatment will be used to test the hypothesis that 4-aminopyridine can speed the determination of nerve continuity after peripheral nerve traction and/or crush injuries allowing the identification of incomplete injuries earlier than standard electrodiagnostic (EDX) and clinical assessment. Participants will be randomized to one of two groups to determine the order of treatment they receive (drug and placebo vs placebo and drug). Participants will undergo baseline testing for nerve assessment, receive either drug or placebo based on randomization and undergo hourly sensory and motor evaluation, EDX testing and serum 4AP levels for three hours after dosing. Participants will then repeat this with the crossover arm.
Description
This is a single-center study that will be conducted at the University of Arizona College of Medicine, Tucson. It is a double-blind, randomized, crossover trial design. Group A will receive the study drug followed by the placebo on the main trial day, and Group B will receive placebo first followed by the study drug. These groups will exist for both aims (both types of included patients). Patients are randomized for the order (drug and placebo vs placebo and drug) of treatment they receive. Eligible, consented patients will present for testing from one of three locations (emergency department…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Drug4-Aminopyridine
Study drug will be a one time, 10mg dose of 4-aminopyridine
- OtherPlacebo
Matched placebo
Location
- Banner University Medical CenterTucson, Arizona