Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
- Conditions
- Peripheral Nerve Injury Upper LimbNerve PalsyNerve InjuryPeripheral Nerve Injuries
- Interventions
- Device: Checkpoint BEST System
- Registration Number
- NCT05884125
- Lead Sponsor
- Checkpoint Surgical Inc.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brief Electrical Stimulation Therapy Checkpoint BEST System Single, 10 minute dose of electrical stimulation delivered to the injured nerve during surgical intervention.
- Primary Outcome Measures
Name Time Method Change in Motor Recovery assessed using the Medical Research Council (MRC) motor grading 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 Outcome Measures
Name Time Method Grip Strength Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months Maximum grip strength.
Semmes-Weinstein Monofilament Testing Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months Evaluation of sensory function, measuring pressure detection threshold.
Motor Unit Number Estimation (MUNE) 4 months, 6 months, and 8 months Estimate of the number of motor units within the muscle based on recorded electrical activity.
Lateral Pinch Strength Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months Maximum lateral pinch.
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 Questionnaire providing patient reported estimate of upper extremity function on a 0-100 scale with \>50 representing greater normal function.
Electromyography (EMG) 4 months, 6 months, and 8 months Measurement of the electrical activity in a muscle.
2-point discrimination Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months Evaluation of sensory function, measuring tactile discrimination.
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 Questionnaire providing patient reported estimate of interference of pain on daily activities on a 0-100 scale with \>50 representing greater than normal pain interference on daily activities.
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 Questionnaire providing patient reported estimate upper extremity function. The score ranges from 0 (no disability) to 100 (most severe disability).
Trial Locations
- Locations (1)
The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
🇺🇸Columbus, Ohio, United States