Promoting Healing Of Nerves Through Electrical Stimulation (PHONES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04662320|
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : March 22, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Cubital Tunnel Syndrome Nerve Compression Nerve Injury Ulnar Neuropathies||Device: Checkpoint BEST System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Promoting Healing Of Nerves Through Electrical Stimulation|
|Actual Study Start Date :||September 1, 2021|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
Experimental: Brief Electrical Stimulation
Single, 10 minute dose of electrical stimulation delivered to the ulnar nerve during surgical intervention for cubital tunnel decompression.
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 Name: Checkpoint BEST System
Other Name: Brief Electrical Stimulation (BES) Therapy
No Intervention: Standard of Care
Surgical intervention for cubital tunnel decompression.
- Change in Grip Strength at 1 year. [ Time Frame: 1 year ]Change in grip strength at 1 year from baseline (pre-operative) assessment.
- Grip Strength [ Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year ]Maximum grip strength
- Lateral Pinch Strength [ Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year ]Maximum lateral pinch strength
- 2-point discrimination [ Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year ]Evaluation of sensory function, measuring tactile discrimination.
- Semmes-Weinstein Monofilament Testing [ Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year ]Evaluation of sensory function, measuring pressure detection threshold.
- Medical Research Council (MRC) motor grading. [ Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year ]Grading of muscle strength on 0 to 5 scale, with higher score representing greater function.
- Maximal finger spread measurement. [ Time Frame: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year ]Measurement of maximal finger spread.
- Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function [ Time Frame: Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year ]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 [ Time Frame: Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year ]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) [ Time Frame: Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year ]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) [ Time Frame: Pre-surgery, 3 months, and 7 months ]Measurement of how quickly an electrical impulse moves along the nerve.
- Electromyography (EMG) [ Time Frame: Pre-surgery, 3 months, and 7 months ]Measurement of the electrical activity in a muscle.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04662320
|Contact: Eric Walker, PhD||216-378-9107 ext email@example.com|
|United States, Illinois|
|Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Clinical Research Coordinator 312-695-4463 firstname.lastname@example.org|
|Principal Investigator: Jason Ko, MD|
|United States, Missouri|
|Washington University in St. Louis||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Clinical Reseach Coordinator 314-454-5967|
|Principal Investigator: David Brogan, MD|
|Sub-Investigator: Christopher Dy, MD|
|United States, Ohio|
|The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery||Recruiting|
|Columbus, Ohio, United States, 43212|
|Contact: Research Coordinator 614-293-8566 email@example.com|
|Principal Investigator: Amy M Moore, MD|
|Sub-Investigator: Hisham Awan, MD|
|Sub-Investigator: Sonu Jain, MD|
|Sub-Investigator: Kanu Goyal, MD|
|Sub-Investigator: Ryan Schmucker, MD|
|Sub-Investigator: Amy Speeckaert, MD|
|Sub-Investigator: Ronald Brown, MD|
|Sub-Investigator: Jill Putnam, MD|
|United States, Wisconsin|
|Medical College of Wisconsin - Hand Center||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator: Gwendolyn Hoben, MD, PhD|
|Principal Investigator:||Amy M Moore, MD||The Ohio State Univeristy Department of Plastic and Reconstructive Surgery|
|Responsible Party:||Checkpoint Surgical Inc.|
|Other Study ID Numbers:||
W81XWH1920065 ( Other Grant/Funding Number: Department of Defense USAMRAA )
|First Posted:||December 10, 2020 Key Record Dates|
|Last Update Posted:||March 22, 2023|
|Last Verified:||March 2023|
|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|
Therapeutic Electrical Stimulation
Cubital Tunnel Syndrome
Peripheral Nervous System Diseases
Nervous System Diseases
Ulnar Nerve Compression Syndromes
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries