Status:
ACTIVE_NOT_RECRUITING
Promoting Healing of Nerves Through Electrical Stimulation
Lead Sponsor:
Checkpoint Surgical Inc.
Collaborating Sponsors:
Congressionally Directed Medical Research Programs
Conditions:
Cubital Tunnel Syndrome
Nerve Compression
Eligibility:
All Genders
18-80 years
Phase:
NA
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 o...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04662320
Start Date
September 1 2021
End Date
December 1 2025
Last Update
December 5 2024
Active Locations (5)
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1
Stanford University
Stanford, California, United States, 94304
2
Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery
Chicago, Illinois, United States, 60611
3
Washington University in St. Louis
St Louis, Missouri, United States, 63110
4
The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
Columbus, Ohio, United States, 43212