Cubital Tunnel Syndrome, Nerve Compression, Nerve Injury, Ulnar Neuropathies
Conditions
Keywords
Therapeutic Electrical Stimulation, Nerve Regeneration, Nerve Healing, Nerve Injury, Cubital Tunnel, Ulnar Nerve
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.
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. Other Name: Checkpoint BEST System
Sponsors
Congressionally Directed Medical Research Programs
Checkpoint Surgical Inc.
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Grip Strength at 1 year. | 1 year | Change in grip strength at 1 year from baseline (pre-operative) assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lateral Pinch Strength | Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year | Maximum lateral pinch strength |
| 2-point discrimination | Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year | Evaluation of sensory function, measuring tactile discrimination. |
| Semmes-Weinstein Monofilament Testing | Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year | Evaluation of sensory function, measuring pressure detection threshold. |
| Medical Research Council (MRC) motor grading. | Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year | Grading of muscle strength on 0 to 5 scale, with higher score representing greater function. |
| Maximal finger spread measurement. | Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year | Measurement of maximal finger spread. |
| Grip Strength | Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year | Maximum grip strength |
| 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 | 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. |
| Michigan Hand Questionnaire (MHQ) | Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year | MHQ is a patient reported estimate of hand function on a 0-100 scale with a higher number indication greater hand function. |
| Nerve Conduction Velocity (NCV) | Pre-surgery, 3 months, and 7 months | Measurement of how quickly an electrical impulse moves along the nerve. |
| Electromyography (EMG) | Pre-surgery, 3 months, and 7 months | Measurement of the electrical activity in a muscle. |
| 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 | Questionnaire providing patient reported estimate of upper extremity function on a 0-100 scale with \>50 representing greater normal function. |
Countries
United States
Outcome results
None listed