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Promoting Healing Of Nerves Through Electrical Stimulation (PHONES)

Primary Purpose

Cubital Tunnel Syndrome, Nerve Compression, Nerve Injury

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 Cubital Tunnel Syndrome focused on measuring Therapeutic Electrical Stimulation, Nerve Regeneration, Nerve Healing, Nerve Injury, Cubital Tunnel, Ulnar Nerve

Eligibility Criteria

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

Inclusion Criteria:

  • Electrodiagnostic evidence of ulnar neuropathy at the elbow.
  • Are candidates for surgical intervention.
  • Evidence of motor involvement such as intrinsic muscle atrophy or weakness.
  • Are age 18-80 years.
  • Signed and dated informed consent form.

Exclusion Criteria:

  • Severe comorbid condition, such as arrythmia or congestive heart failure, preventing surgery
  • Previous history or current transection of ulnar nerve, or concomitant upper extremity nerve injury
  • Global peripheral neuropathy affecting the hands
  • Age less than 18 or greater than 80 years
  • Un-affected hand maximum grip strength <12kg

Sites / Locations

  • Northwestern Feinberg School of Medicine - Department of Orthopaedic SurgeryRecruiting
  • Washington University in St. LouisRecruiting
  • The Ohio State Univeristy - Department of Plastic and Reconstructive SurgeryRecruiting
  • Medical College of Wisconsin - Hand CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brief Electrical Stimulation

Standard of Care

Arm Description

Single, 10 minute dose of electrical stimulation delivered to the ulnar nerve during surgical intervention for cubital tunnel decompression.

Surgical intervention for cubital tunnel decompression.

Outcomes

Primary Outcome Measures

Change in Grip Strength at 1 year.
Change in grip strength at 1 year from baseline (pre-operative) assessment.

Secondary Outcome Measures

Grip Strength
Maximum grip strength
Lateral Pinch Strength
Maximum lateral pinch strength
2-point discrimination
Evaluation of sensory function, measuring tactile discrimination.
Semmes-Weinstein Monofilament Testing
Evaluation of sensory function, measuring pressure detection threshold.
Medical Research Council (MRC) motor grading.
Grading of muscle strength on 0 to 5 scale, with higher score representing greater function.
Maximal finger spread measurement.
Measurement of maximal finger spread.
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.
Michigan Hand Questionnaire (MHQ)
MHQ is a patient reported estimate of hand function on a 0-100 scale with a higher number indication greater hand function.
Nerve Conduction Velocity (NCV)
Measurement of how quickly an electrical impulse moves along the nerve.
Electromyography (EMG)
Measurement of the electrical activity in a muscle.

Full Information

First Posted
November 24, 2020
Last Updated
March 20, 2023
Sponsor
Checkpoint Surgical Inc.
Collaborators
Congressionally Directed Medical Research Programs
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1. Study Identification

Unique Protocol Identification Number
NCT04662320
Brief Title
Promoting Healing Of Nerves Through Electrical Stimulation
Acronym
PHONES
Official Title
Promoting Healing Of Nerves Through Electrical Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (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 nerve compression. A single dose of the therapeutic stimulation is delivered as part of the surgical intervention to address compression of the ulnar nerve at the elbow.
Detailed Description
Preliminary research has shown that delivering a brief period of electrical stimulation following nerve repair promotes nerve healing and functional recovery. This 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 compression of the ulnar nerve at the elbow, commonly referred to as Cubital Tunnel Syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cubital Tunnel Syndrome, Nerve Compression, Nerve Injury, Ulnar Neuropathies
Keywords
Therapeutic Electrical Stimulation, Nerve Regeneration, Nerve Healing, Nerve Injury, Cubital Tunnel, Ulnar Nerve

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Brief Electrical Stimulation
Arm Type
Experimental
Arm Description
Single, 10 minute dose of electrical stimulation delivered to the ulnar nerve during surgical intervention for cubital tunnel decompression.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Surgical intervention for cubital tunnel decompression.
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. Other Name: Checkpoint BEST System
Primary Outcome Measure Information:
Title
Change in Grip Strength at 1 year.
Description
Change in grip strength at 1 year from baseline (pre-operative) assessment.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Grip Strength
Description
Maximum grip strength
Time Frame
Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Title
Lateral Pinch Strength
Description
Maximum lateral pinch strength
Time Frame
Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Title
2-point discrimination
Description
Evaluation of sensory function, measuring tactile discrimination.
Time Frame
Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Title
Semmes-Weinstein Monofilament Testing
Description
Evaluation of sensory function, measuring pressure detection threshold.
Time Frame
Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Title
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, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Title
Maximal finger spread measurement.
Description
Measurement of maximal finger spread.
Time Frame
Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
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, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
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, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Title
Michigan Hand Questionnaire (MHQ)
Description
MHQ is a patient reported estimate of hand function on a 0-100 scale with a higher number indication greater hand function.
Time Frame
Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year
Title
Nerve Conduction Velocity (NCV)
Description
Measurement of how quickly an electrical impulse moves along the nerve.
Time Frame
Pre-surgery, 3 months, and 7 months
Title
Electromyography (EMG)
Description
Measurement of the electrical activity in a muscle.
Time Frame
Pre-surgery, 3 months, and 7 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: Electrodiagnostic evidence of ulnar neuropathy at the elbow. Are candidates for surgical intervention. Evidence of motor involvement such as intrinsic muscle atrophy or weakness. Are age 18-80 years. Signed and dated informed consent form. Exclusion Criteria: Severe comorbid condition, such as arrythmia or congestive heart failure, preventing surgery Previous history or current transection of ulnar nerve, or concomitant upper extremity nerve injury Global peripheral neuropathy affecting the hands Age less than 18 or greater than 80 years Un-affected hand maximum grip strength <12kg
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Walker, PhD
Phone
216-378-9107
Ext
101
Email
ewalker@checkpointsurgical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy M Moore, MD
Organizational Affiliation
The Ohio State Univeristy Department of Plastic and Reconstructive Surgery
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
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
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Reseach Coordinator
Phone
314-454-5967
First Name & Middle Initial & Last Name & Degree
David Brogan, MD
First Name & Middle Initial & Last Name & Degree
Christopher Dy, 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
First Name & Middle Initial & Last Name & Degree
Hisham Awan, MD
First Name & Middle Initial & Last Name & Degree
Sonu Jain, MD
First Name & Middle Initial & Last Name & Degree
Kanu Goyal, MD
First Name & Middle Initial & Last Name & Degree
Ryan Schmucker, MD
First Name & Middle Initial & Last Name & Degree
Amy Speeckaert, MD
First Name & Middle Initial & Last Name & Degree
Ronald Brown, MD
First Name & Middle Initial & Last Name & Degree
Jill Putnam, MD
Facility Name
Medical College of Wisconsin - Hand Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwendolyn Hoben, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31432080
Citation
Power HA, Morhart MJ, Olson JL, Chan KM. Postsurgical Electrical Stimulation Enhances Recovery Following Surgery for Severe Cubital Tunnel Syndrome: A Double-Blind Randomized Controlled Trial. Neurosurgery. 2020 Jun 1;86(6):769-777. doi: 10.1093/neuros/nyz322.
Results Reference
background
PubMed Identifier
19800329
Citation
Gordon T, Amirjani N, Edwards DC, Chan KM. Brief post-surgical electrical stimulation accelerates axon regeneration and muscle reinnervation without affecting the functional measures in carpal tunnel syndrome patients. Exp Neurol. 2010 May;223(1):192-202. doi: 10.1016/j.expneurol.2009.09.020. Epub 2009 Oct 1.
Results Reference
background
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
background
PubMed Identifier
33794683
Citation
Evans A, Padovano WM, Patterson JMM, Wood MD, Fongsri W, Kennedy CR, Mackinnon SE. Beyond the Cubital Tunnel: Use of Adjunctive Procedures in the Management of Cubital Tunnel Syndrome. Hand (N Y). 2023 Mar;18(2):203-213. doi: 10.1177/1558944721998022. Epub 2021 Apr 2.
Results Reference
background
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
background
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
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Promoting Healing Of Nerves Through Electrical Stimulation

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