Using electrical stimulation to help heal injured nerves in the arm
Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
This study tests if adding electrical stimulation during surgery can help people with arm nerve injuries heal better and recover more function than just standard care alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Checkpoint Surgical Inc. Industry-sponsored |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05884125 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a new therapeutic approach using electrical stimulation to enhance nerve healing and functional recovery after surgical intervention for peripheral nerve injuries in the arm. Participants will be randomly assigned to either a treatment group, which receives standard care plus electrical stimulation during surgery, or a control group receiving only standard care. The goal is to determine if the addition of electrical stimulation can improve outcomes compared to standard treatment alone. This pilot study builds on preliminary findings suggesting that brief electrical stimulation may promote nerve regeneration.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with upper extremity mixed or motor nerve injuries who are eligible for surgical intervention.
Not a fit: Patients with severe comorbid conditions or those requiring complex nerve repairs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients with nerve injuries in the arm.
How similar studies have performed: Preliminary research has shown promise for similar electrical stimulation approaches, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Columbus, Ohio
- The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Amy M Moore, MD — Ohio State University
- Study coordinator: Eric Walker, PhD
- Email: ewalker@checkpointsurgical.com
- Phone: 216-370-9107
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.