The goal of this clinical study is to evaluate if a period of electrical stimulation delivered during the surgical repair procedure can speed up nerve healing.
Age 18-80 years
Candidate for surgical intervention under general anesthesia.
Require primary nerve injury repair in at least 1 digital nerve.
Following resection, have a resulting nerve gap of ≤ 10mm.
Severe comorbid conditions, such as arrhythmia or congestive heart failure, preventing surgery under general anesthesia.
Nerve repair occurring >1 month post-injury.
Incomplete nerve transection.
Injury requiring replantation of target digit
Parallel
Brief Electrical Stimulation Therapy
Device10-minutes of electrical stimulation to repaired nerve
Digital Nerve Repair
Procedure/SurgeryStandard of care surgical repair of digital nerve injury as determined by health care provider.
Two Point Discrimination
Evaluation of sensory function based on ability to discern two point of contact for different distances between the contacts (2-15mm). Evaluated at each follow-up visit.
Semmes-Weinstein Monofilament Test
Evaluation of sensory function, measuring pressure detection threshold. Evaluated at each follow-up visit.
Visual Analog Scale (VAS)
Self reported rating of pain marked on a 100mm visual analog scale. Evaluated at each follow-up visit.
quick Disabilities of Arm, Hand, and Shoulder (quickDASH)
Questionnaire providing patient reported estimate upper extremity function following injuries or disorders to the arm, hand, or shoulder. Responses to 11 questions answered on a 1-5 scale are used to calculate a scorescore ranging from 0 (no disability) to 100 (most severe disability). Evaluated at each follow-up visit.
Michigan Hand Outcomes Questionnaire (MHQ)
A patient reported questionnaire consisting of 37 questions answered on a 1-5 scale used to calculate an estimate of hand function on a 0-100 scale with a higher number indication greater hand function. Evaluated at each follow-up visit.
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