Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nerve Injury
- Sponsor
- Checkpoint Surgical Inc.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in Motor Recovery assessed using the Medical Research Council (MRC) motor grading
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Change in Motor Recovery assessed using the Medical Research Council (MRC) motor grading
Time Frame: Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Grading of muscle strength on 0 to 5 scale, with higher score representing greater function.
Secondary Outcomes
- Grip Strength(Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months)
- Semmes-Weinstein Monofilament Testing(Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months)
- Motor Unit Number Estimation (MUNE)(4 months, 6 months, and 8 months)
- Lateral Pinch Strength(Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months)
- Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function(Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months)
- Electromyography (EMG)(4 months, 6 months, and 8 months)
- 2-point discrimination(Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months)
- Patient Reported Outcome Measurement System (PROMIS) Pain Interference(Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months)
- quick Disabilities of thee Arm, Shoulder, and Hand (DASH) questionnaire(Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months)