Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

Not Applicable

Recruiting

• Conditions: Nerve Injury; Peripheral Nerve Injuries; Peripheral Nerve Injury Upper Limb; Nerve Palsy

• Registration Number: NCT05884125
• Lead Sponsor: Checkpoint Surgical Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-5-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inclusion Criteria:<br><br> - Upper extremity mixed or motor nerve injury from the brachial plexus to the wrist<br> crease.<br><br> - Candidate for surgical intervention.<br><br> - Indicated for surgical repair by nerve transfer, primary repair, or nerve grafting.<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 arrhythmia or congestive heart failure,<br> preventing surgery.<br><br> - Primary repair requiring graft >6cm.<br><br> - Nerve reconstruction occurring >12 months post injury.<br><br> - Age less than 18 or greater than 80 years.<br><br> - All contraindications to included/required surgical procedure, including but not<br> limited to language barriers, mental status barriers, inability to consent, and<br> pregnancy/lactation.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Motor Recovery assessed using the Medical Research Council (MRC) motor grading

Secondary Outcome Measures

Name	Time	Method
Grip Strength;Lateral Pinch Strength;2-point discrimination;Semmes-Weinstein Monofilament Testing;Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function;Patient Reported Outcome Measurement System (PROMIS) Pain Interference;quick Disabilities of thee Arm, Shoulder, and Hand (DASH) questionnaire;Electromyography (EMG);Motor Unit Number Estimation (MUNE)