Nerve Injury, Nerve Palsy, Peripheral Nerve Injuries, Peripheral Nerve Injury Upper Limb
Conditions
Keywords
Therapeutic Electrical Stimulation, Brief Electrical Stimulation, Nerve Regeneration, Nerve Injury, Nerve Healing, Nerve Repair
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.
Interventions
DEVICECheckpoint BEST System
Single use medical device, consisting of electric stimulator and intraoperative lead. Therapy consists of single, 10 minute dose delivered proximal to site of decompression/repair
Sponsors
Checkpoint Surgical Inc.
Congressionally Directed Medical Research Programs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Grip Strength | Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months | Maximum grip strength. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| Electromyography (EMG) | 4 months, 6 months, and 8 months | Measurement of the electrical activity in a muscle. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmy M Moore, MD
Ohio State University
Outcome results
None listed