Promoting Healing of Nerves Through Electrical Stimulation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cubital Tunnel Syndrome
- Sponsor
- Checkpoint Surgical Inc.
- Enrollment
- 100
- Locations
- 5
- Primary Endpoint
- Change in Grip Strength at 1 year.
- Status
- Active, not 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 nerve compression. A single dose of the therapeutic stimulation is delivered as part of the surgical intervention to address compression of the ulnar nerve at the elbow.
Detailed Description
Preliminary research has shown that delivering a brief period of electrical stimulation following nerve repair promotes nerve healing and functional recovery. This 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 compression of the ulnar nerve at the elbow, commonly referred to as Cubital Tunnel Syndrome.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Electrodiagnostic evidence of ulnar neuropathy at the elbow.
- •Are candidates for surgical intervention.
- •Evidence of motor involvement such as intrinsic muscle atrophy or weakness.
- •Are age 18-80 years.
- •Signed and dated informed consent form.
Exclusion Criteria
- •Severe comorbid condition, such as arrythmia or congestive heart failure, preventing surgery
- •Previous history or current transection of ulnar nerve, or concomitant upper extremity nerve injury
- •Global peripheral neuropathy affecting the hands
- •Age less than 18 or greater than 80 years
- •Un-affected hand maximum grip strength \<12kg
Outcomes
Primary Outcomes
Change in Grip Strength at 1 year.
Time Frame: 1 year
Change in grip strength at 1 year from baseline (pre-operative) assessment.
Secondary Outcomes
- Medical Research Council (MRC) motor grading.(Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function(Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- Michigan Hand Questionnaire (MHQ)(Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- 2-point discrimination(Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- Lateral Pinch Strength(Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- Patient Reported Outcome Measurement System (PROMIS) Pain Interference(Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- Electromyography (EMG)(Pre-surgery, 3 months, and 7 months)
- Grip Strength(Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- Semmes-Weinstein Monofilament Testing(Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- Maximal finger spread measurement.(Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year)
- Nerve Conduction Velocity (NCV)(Pre-surgery, 3 months, and 7 months)