Promoting Healing of Nerves Through Electrical Stimulation (PHONES)

Checkpoint Surgical

Status

Active, not recruiting

Conditions

Nerve Compression

Ulnar Neuropathies

Cubital Tunnel Syndrome

Nerve Injury

Treatments

Device: Checkpoint BEST System

Study type

Interventional

Funder types

Industry

Other U.S. Federal agency

Identifiers

NCT04662320

W81XWH1920065 (Other Grant/Funding Number)

0153-CSP-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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