Promoting Healing Of Nerves Through Electrical Stimulation

Not Applicable

Recruiting

• Conditions: Cubital Tunnel Syndrome; Nerve Compression; Nerve Injury; Ulnar Neuropathies

• Registration Number: NCT04662320
• Lead Sponsor: Checkpoint Surgical Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-24
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion Criteria:<br><br> - Electrodiagnostic evidence of ulnar neuropathy at the elbow.<br><br> - Are candidates for surgical intervention.<br><br> - Evidence of motor involvement such as intrinsic muscle atrophy or weakness.<br><br> - Are age 18-80 years.<br><br> - Signed and dated informed consent form.<br><br>Exclusion Criteria:<br><br> - Severe comorbid condition, such as arrythmia or congestive heart failure, preventing<br> surgery<br><br> - Previous history or current transection of ulnar nerve, or concomitant upper<br> extremity nerve injury<br><br> - Global peripheral neuropathy affecting the hands<br><br> - Age less than 18 or greater than 80 years<br><br> - Un-affected hand maximum grip strength <12kg

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Grip Strength at 1 year.

Secondary Outcome Measures

Name	Time	Method
Grip Strength;Lateral Pinch Strength;2-point discrimination;Semmes-Weinstein Monofilament Testing;Medical Research Council (MRC) motor grading.;Maximal finger spread measurement.;Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function;Patient Reported Outcome Measurement System (PROMIS) Pain Interference;Michigan Hand Questionnaire (MHQ);Nerve Conduction Velocity (NCV);Electromyography (EMG)