PHINEST: Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

• Sponsor: Checkpoint Surgical Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05884125
• Collaborator: Congressionally Directed Medical Research Programs (U.S. Fed)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site: 30
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Nerve Injury; Peripheral Nerve Injuries; Peripheral Nerve Injury Upper Limb; Nerve Palsy	Device: Checkpoint BEST System	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2027
• Anticipated Study Completion Date: Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brief Electrical Stimulation Therapy Single, 10 minute dose of electrical stimulation delivered to the injured nerve during surgical 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; Other Names: Brief Electrical Stimulation (BES) Therapy
No Intervention: Standard of Care Surgical intervention for repair of peripheral nerve injury.

Outcome Measures

Primary Outcome Measures

1. Change in Motor Recovery assessed using the Medical Research Council (MRC) motor grading [Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months]

   Grading of muscle strength on 0 to 5 scale, with higher score representing greater function.

Secondary Outcome Measures

1. Grip Strength [Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months]

   Maximum grip strength.

2. Lateral Pinch Strength [Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months]

   Maximum lateral pinch.

3. 2-point discrimination [Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months]

   Evaluation of sensory function, measuring tactile discrimination.

4. Semmes-Weinstein Monofilament Testing [Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months]

   Evaluation of sensory function, measuring pressure detection threshold.

5. Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function [Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months]

   Questionnaire providing patient reported estimate of upper extremity function on a 0-100 scale with >50 representing greater normal function.

6. Patient Reported Outcome Measurement System (PROMIS) Pain Interference [Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months]

   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.

7. quick Disabilities of thee Arm, Shoulder, and Hand (DASH) questionnaire [Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months]

   Questionnaire providing patient reported estimate upper extremity function. The score ranges from 0 (no disability) to 100 (most severe disability).

8. Electromyography (EMG) [4 months, 6 months, and 8 months]

   Measurement of the electrical activity in a muscle.

9. Motor Unit Number Estimation (MUNE) [4 months, 6 months, and 8 months]

   Estimate of the number of motor units within the muscle based on recorded electrical activity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery	Chicago	Illinois	United States	60611
2	The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery	Columbus	Ohio	United States	43212

Sponsors and Collaborators

• Checkpoint Surgical Inc.
• Congressionally Directed Medical Research Programs

Investigators

• Principal Investigator: Amy M Moore, MD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Checkpoint Surgical Inc.
• ClinicalTrials.gov Identifier: NCT05884125
• Other Study ID Numbers: 0153-CSP-002; W81XWH1920065
• First Posted: Jun 1, 2023
• Last Update Posted: Jun 1, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Checkpoint Surgical Inc.: Therapeutic Electrical Stimulation; Brief Electrical Stimulation; Nerve Regeneration; Nerve Injury; Nerve Healing; Nerve Repair
• Additional relevant MeSH terms: Peripheral Nerve Injuries; Wounds and Injuries

Study Results

No Results Posted as of Jun 1, 2023