Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCheckpoint Surgical Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Checkpoint BEST System
DeviceSingle use medical device, consisting of electric stimulator and intraoperative lead. Therapy consists of single, 10 minute dose delivered proximal to site of decompression/repair
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Brief Electrical Stimulation TherapyExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Motor Recovery assessed using the Medical Research Council (MRC) motor grading
Grading of muscle strength on 0 to 5 scale, with higher score representing greater function.
Time frame
Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 monthsSecondary outcomes
1
Grip Strength
Maximum grip strength.
Time frame
Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months2
Lateral Pinch Strength
Maximum lateral pinch.
Time frame
Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months3
2-point discrimination
Evaluation of sensory function, measuring tactile discrimination.
Time frame
Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months4
Semmes-Weinstein Monofilament Testing
Evaluation of sensory function, measuring pressure detection threshold.
Time frame
Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Checkpoint Surgical Inc.
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov