Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

Recruiting now · Not applicable

Conditions studied: Nerve Injury, Peripheral Nerve Injuries, Peripheral Nerve Injury Upper Limb, Nerve Palsy

In brief

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.

Key facts

Study ID

NCT05884125

Run by

Checkpoint Surgical Inc.

People needed

60

Starts

2023-06-12

Expected to finish

2027-06-01

Last updated by the study team

2024-08-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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