Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for peripheral nerve injury in arm. Participants will be randomized into one of two groups, treatment or control, with all participants receiving standard of
| Condition(s) | Nerve Injury, Peripheral Nerve Injuries, Peripheral Nerve Injury Upper Limb, Nerve Palsy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for peripheral nerve injury in arm. Participants will be randomized into one of two groups, treatment or control, with all participants receiving standard of care treatment for the nerve injury. The treatment group will also receive a single dose of the therapeutic stimulation during the surgical intervention for their nerve injury. |
| Who can participate | Inclusion Criteria: * Upper extremity mixed or motor nerve injury from the brachial plexus to the wrist crease. * Candidate for surgical intervention. * Indicated for surgical repair by nerve transfer, primary repair, or nerve grafting. * Are age 18-80 years. * Signed and dated informed consent form. Exclusion Criteria: * Severe comorbid condition, such as arrhythmia or congestive heart failure, preventing surgery. * Primary repair requiring graft \>6cm. * Nerve reconstruction occurring \>12 months post injury. * Age less than 18 or greater than 80 years. * All contraindications to included/required surgical procedure, including but not limited to language barriers, mental status barriers, inability to consent, and pregnancy/lactation. |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Checkpoint Surgical Inc. |
| Locations | Columbus, Ohio, United States |
| Start date | 2023-06-12 |
| NCT ID | NCT05884125 |
| Official listing | https://clinicaltrials.gov/study/NCT05884125 |