Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
Purpose
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.
Conditions
- Nerve Injury
- Peripheral Nerve Injuries
- Peripheral Nerve Injury Upper Limb
- Nerve Palsy
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Brief Electrical Stimulation Therapy |
Single, 10 minute dose of electrical stimulation delivered to the injured nerve during surgical intervention. |
|
|
No Intervention Standard of Care |
Surgical intervention for repair of peripheral nerve injury. |
|
Recruiting Locations
Columbus, Ohio 43212
More Details
- Status
- Recruiting
- Sponsor
- Checkpoint Surgical Inc.
Detailed Description
Preliminary research has shown that delivering a brief period of electrical stimulation following nerve repair promotes nerve healing and functional recovery. This pilot study is investigating the use of a single dose of therapeutic electrical stimulation to promote nerve healing. The therapy is delivered as part of the surgical intervention to address peripheral nerve injury in the arm.