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

Primary Purpose

Nerve Injury, Peripheral Nerve Injuries, Peripheral Nerve Injury Upper Limb

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Checkpoint BEST System
Sponsored by
Checkpoint Surgical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nerve Injury focused on measuring Therapeutic Electrical Stimulation, Brief Electrical Stimulation, Nerve Regeneration, Nerve Injury, Nerve Healing, Nerve Repair

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery
  • The Ohio State Univeristy - Department of Plastic and Reconstructive SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brief Electrical Stimulation Therapy

Standard of Care

Arm Description

Single, 10 minute dose of electrical stimulation delivered to the injured nerve during surgical intervention.

Surgical intervention for repair of peripheral nerve injury.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Grip Strength
Maximum grip strength.
Lateral Pinch Strength
Maximum lateral pinch.
2-point discrimination
Evaluation of sensory function, measuring tactile discrimination.
Semmes-Weinstein Monofilament Testing
Evaluation of sensory function, measuring pressure detection threshold.
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.
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.
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).
Electromyography (EMG)
Measurement of the electrical activity in a muscle.
Motor Unit Number Estimation (MUNE)
Estimate of the number of motor units within the muscle based on recorded electrical activity.

Full Information

First Posted
May 19, 2023
Last Updated
June 12, 2023
Sponsor
Checkpoint Surgical Inc.
Collaborators
Congressionally Directed Medical Research Programs
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1. Study Identification

Unique Protocol Identification Number
NCT05884125
Brief Title
Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
Acronym
PHINEST
Official Title
Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Checkpoint Surgical Inc.
Collaborators
Congressionally Directed Medical Research Programs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Injury, Peripheral Nerve Injuries, Peripheral Nerve Injury Upper Limb, Nerve Palsy
Keywords
Therapeutic Electrical Stimulation, Brief Electrical Stimulation, Nerve Regeneration, Nerve Injury, Nerve Healing, Nerve Repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brief Electrical Stimulation Therapy
Arm Type
Experimental
Arm Description
Single, 10 minute dose of electrical stimulation delivered to the injured nerve during surgical intervention.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Surgical intervention for repair of peripheral nerve injury.
Intervention Type
Device
Intervention Name(s)
Checkpoint BEST System
Other Intervention Name(s)
Brief Electrical Stimulation (BES) Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Motor Recovery assessed using the Medical Research Council (MRC) motor grading
Description
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 months
Secondary Outcome Measure Information:
Title
Grip Strength
Description
Maximum grip strength.
Time Frame
Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Title
Lateral Pinch Strength
Description
Maximum lateral pinch.
Time Frame
Pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Title
2-point discrimination
Description
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 months
Title
Semmes-Weinstein Monofilament Testing
Description
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 months
Title
Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function
Description
Questionnaire providing patient reported estimate of upper extremity function on a 0-100 scale with >50 representing greater normal function.
Time Frame
Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Title
Patient Reported Outcome Measurement System (PROMIS) Pain Interference
Description
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.
Time Frame
Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Title
quick Disabilities of thee Arm, Shoulder, and Hand (DASH) questionnaire
Description
Questionnaire providing patient reported estimate upper extremity function. The score ranges from 0 (no disability) to 100 (most severe disability).
Time Frame
Pre-surgery, 10 days, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Title
Electromyography (EMG)
Description
Measurement of the electrical activity in a muscle.
Time Frame
4 months, 6 months, and 8 months
Title
Motor Unit Number Estimation (MUNE)
Description
Estimate of the number of motor units within the muscle based on recorded electrical activity.
Time Frame
4 months, 6 months, and 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Walker, PhD
Phone
216-370-9107
Ext
101
Email
ewalker@checkpointsurgical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy M Moore, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Research Coordinator
Phone
312-695-4463
Email
orthosurveys@nm.org
First Name & Middle Initial & Last Name & Degree
Jason Ko, MD
Facility Name
The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
614-293-8566
Email
nervenerds@osumc.edu
First Name & Middle Initial & Last Name & Degree
Amy M Moore, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31397919
Citation
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.
Results Reference
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PubMed Identifier
34668879
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.
Results Reference
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PubMed Identifier
35139047
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.
Results Reference
background
PubMed Identifier
25727139
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.
Results Reference
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PubMed Identifier
36551285
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.
Results Reference
background
PubMed Identifier
32666827
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.
Results Reference
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Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

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