Promoting Healing of Injured Nerves With Electrical Stimulation Therapy (PHINEST)

Checkpoint Surgical

Status

Enrolling

Conditions

Nerve Palsy

Peripheral Nerve Injuries

Peripheral Nerve Injury Upper Limb

Nerve Injury

Treatments

Device: Checkpoint BEST System

Study type

Interventional

Funder types

Industry

Other U.S. Federal agency

Identifiers

NCT05884125

0153-CSP-002

W81XWH1920065 (Other Grant/Funding Number)

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 peripheral nerve injury in arm. Participants will be randomized into one of two groups, treatment or control, with all participants receiving standard of care treatment for the nerve injury. The treatment group will also receive a single dose of the therapeutic stimulation during the surgical intervention for their nerve injury.

Full description

Preliminary research has shown that delivering a brief period of electrical stimulation following nerve repair promotes nerve healing and functional recovery. This pilot 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 peripheral nerve injury in the arm.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Upper extremity mixed or motor nerve injury from the brachial plexus to the wrist crease.
Candidate for surgical intervention.
Indicated for surgical repair by nerve transfer, primary repair, or nerve grafting.
Are age 18-80 years.
Signed and dated informed consent form.

Exclusion criteria

Severe comorbid condition, such as arrhythmia or congestive heart failure, preventing surgery.
Primary repair requiring graft >6cm.
Nerve reconstruction occurring >12 months post injury.
Age less than 18 or greater than 80 years.
All contraindications to included/required surgical procedure, including but not limited to language barriers, mental status barriers, inability to consent, and pregnancy/lactation.