Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

Nerve Injury Clinical Trial

— PHINEST  

Official title:

Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05884125
• Other study ID #: 0153-CSP-002
• Secondary ID: W81XWH1920065
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2023
• Est. completion date: June 2027

Study information

• Verified date: June 2023
• Source: Checkpoint Surgical Inc.
• Contact: Eric Walker, PhD
• Phone: 216-370-9107
• Email: ewalker[@]checkpointsurgical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nerve Injury
• Nerve Palsy
• Peripheral Nerve Injuries
• Peripheral Nerve Injury Upper Limb
• Wounds and Injuries

Intervention

Device:
• Checkpoint BEST System
Single use medical device, consisting of electric stimulator and intraoperative lead. Therapy consists of single, 10 minute dose delivered proximal to site of decompression/repair

Locations

Country	Name	City	State
United States	Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery	Chicago	Illinois
United States	The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Checkpoint Surgical Inc.	Congressionally Directed Medical Research Programs

Country where clinical trial is conducted

United States, 

References & Publications (6)

Jo S, Pan D, Halevi AE, Roh J, Schellhardt L, Hunter Ra DA, Snyder-Warwick AK, Moore AM, Mackinnon SE, Wood MD. Comparing electrical stimulation and tacrolimus (FK506) to enhance treating nerve injuries. Muscle Nerve. 2019 Nov;60(5):629-636. doi: 10.1002/mus.26659. Epub 2019 Aug 21. — View Citation

Juckett L, Saffari TM, Ormseth B, Senger JL, Moore AM. The Effect of Electrical Stimulation on Nerve Regeneration Following Peripheral Nerve Injury. Biomolecules. 2022 Dec 12;12(12):1856. doi: 10.3390/biom12121856. — View Citation

Keane GC, Pan D, Roh J, Larson EL, Schellhardt L, Hunter DA, Snyder-Warwick AK, Moore AM, Mackinnon SE, Wood MD. The Effects of Intraoperative Electrical Stimulation on Regeneration and Recovery After Nerve Isograft Repair in a Rat Model. Hand (N Y). 2022 May;17(3):540-548. doi: 10.1177/1558944720939200. Epub 2020 Jul 15. — View Citation

Roh J, Schellhardt L, Keane GC, Hunter DA, Moore AM, Snyder-Warwick AK, Mackinnon SE, Wood MD. Short-Duration, Pulsatile, Electrical Stimulation Therapy Accelerates Axon Regeneration and Recovery following Tibial Nerve Injury and Repair in Rats. Plast Reconstr Surg. 2022 Apr 1;149(4):681e-690e. doi: 10.1097/PRS.0000000000008924. — View Citation

Sayanagi J, Acevedo-Cintron JA, Pan D, Schellhardt L, Hunter DA, Snyder-Warwick AK, Mackinnon SE, Wood MD. Brief Electrical Stimulation Accelerates Axon Regeneration and Promotes Recovery Following Nerve Transection and Repair in Mice. J Bone Joint Surg Am. 2021 Oct 20;103(20):e80. doi: 10.2106/JBJS.20.01965. — View Citation

Wong JN, Olson JL, Morhart MJ, Chan KM. Electrical stimulation enhances sensory recovery: a randomized controlled trial. Ann Neurol. 2015 Jun;77(6):996-1006. doi: 10.1002/ana.24397. Epub 2015 May 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Secondary	Grip Strength	Maximum grip strength.	Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Secondary	Lateral Pinch Strength	Maximum lateral pinch.	Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Secondary	2-point discrimination	Evaluation of sensory function, measuring tactile discrimination.	Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Secondary	Semmes-Weinstein Monofilament Testing	Evaluation of sensory function, measuring pressure detection threshold.	Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Secondary	Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function	Questionnaire providing patient reported estimate of upper extremity function on a 0-100 scale with >50 representing greater normal function.	Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Secondary	Patient Reported Outcome Measurement System (PROMIS) Pain Interference	Questionnaire providing patient reported estimate of interference of pain on daily activities on a 0-100 scale with >50 representing greater than normal pain interference on daily activities.	Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Secondary	quick Disabilities of thee Arm, Shoulder, and Hand (DASH) questionnaire	Questionnaire providing patient reported estimate upper extremity function. The score ranges from 0 (no disability) to 100 (most severe disability).	Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Secondary	Electromyography (EMG)	Measurement of the electrical activity in a muscle.	4 months, 6 months, and 8 months
Secondary	Motor Unit Number Estimation (MUNE)	Estimate of the number of motor units within the muscle based on recorded electrical activity.	4 months, 6 months, and 8 months