Study on Nerve Injury Treatment Using a Temporary Electrical Stimulation Device Evaluating Safety and Effectiveness of a Single 1-Hour Therapy Dose

What this Trial Is About

Researchers are evaluating a novel temporary peripheral nerve stimulation system to study its safety and effectiveness in helping regenerate acutely injured nerves. This study is designed to assess sensory recovery and monitor adverse events over a six-month period in adults with nerve injuries. The trial is randomized and double-blinded to compare the nerve stimulation device with a sham treatment. Participants will receive a single dose of electrical stimulation therapy lasting one hour, delivered by a single-use medical device placed near the injury site. The study groups include an active treatment group receiving the actual nerve stimulation and a sham group receiving a similar procedure without active stimulation. Both treatments are given once. Throughout the study, participants will be monitored for sensory recovery and any adverse effects at the six-month mark. The trial includes regular evaluations to track the progress of nerve regeneration and the safety of the device. The total participation period covers six months from treatment to final assessment.

Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation