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Cubital Tunnel SyndromePHONESNCT04662320

Promoting Healing of Nerves Through Electrical Stimulation

A study testing Checkpoint BEST System in people with Cubital Tunnel Syndrome and Nerve Compression, run by Checkpoint Surgical Inc. at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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 nerve compression. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Checkpoint BEST System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
5 sitesUnited States
Study dates
1 Sep 2021to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery

    Chicago, Illinois, 60611

  • The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery

    Columbus, Ohio, 43212

  • Medical College of Wisconsin - Hand Center

    Milwaukee, Wisconsin, 53226

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • Stanford University

    Stanford, California, 94304

Other trials in United States

About this study

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.

Read the 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.

Being tested
Checkpoint BEST System
Keywords
Therapeutic Electrical Stimulation, Nerve Regeneration, Nerve Healing, Nerve Injury, Cubital Tunnel, Ulnar Nerve
Medical subject headings
Cubital Tunnel Syndrome, Neuroma, Ulnar Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Checkpoint BEST SystemDevice

    Also called Brief Electrical Stimulation (BES) Therapy

    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

Study groups in NCT04662320
Study groupRoleWhat they receive
Brief Electrical StimulationExperimentalSingle, 10 minute dose of electrical stimulation delivered to the ulnar nerve during surgical intervention for cubital tunnel decompression.
Receives: Device: Checkpoint BEST System
Standard of CareNo interventionSurgical intervention for cubital tunnel decompression.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Grip Strength at 1 year.

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

    Measured: 1 year

Secondary outcomes (11)

  1. Grip Strength

    Maximum grip strength

    Measured: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year

  2. Lateral Pinch Strength

    Maximum lateral pinch strength

    Measured: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year

  3. 2-point discrimination

    Evaluation of sensory function, measuring tactile discrimination.

    Measured: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year

  4. Semmes-Weinstein Monofilament Testing

    Evaluation of sensory function, measuring pressure detection threshold.

    Measured: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year

  5. Medical Research Council (MRC) motor grading.

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

    Measured: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year

  6. Maximal finger spread measurement.

    Measurement of maximal finger spread.

    Measured: Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year

  7. 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.

    Measured: Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year

  8. 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.

    Measured: Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year

  9. 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.

    Measured: Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year

  10. Nerve Conduction Velocity (NCV)

    Measurement of how quickly an electrical impulse moves along the nerve.

    Measured: Pre-surgery, 3 months, and 7 months

  11. Electromyography (EMG)

    Measurement of the electrical activity in a muscle.

    Measured: Pre-surgery, 3 months, and 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2020
  2. Study start1 Sep 2021
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04662320
Sponsor's protocol ID
0153-CSP-001
Other IDs
W81XWH1920065
Acronym
PHONES
Status last verified
Dec 2024
First submitted
24 Nov 2020
Last updated
5 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Saffari TM, Walker ER, Pet MA, Moore AM. Brief Intraoperative Electrical Stimulation to Enhance Nerve Regeneration. Plast Reconstr Surg Glob Open. 2024 Apr 10;12(4):e5730. doi: 10.1097/GOX.0000000000005730. eCollection 2024 Apr. No abstract available.

    PubMed 38600968

  • 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.

    PubMed 31432080

  • 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.

    PubMed 19800329

  • 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.

    PubMed 31397919

  • 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.

    PubMed 33794683

  • 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.

    PubMed 34668879

  • 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.

    PubMed 35139047

Questions about this trial

What is this clinical trial studying?

A study testing Checkpoint BEST System in people with Cubital Tunnel Syndrome and Nerve Compression, run by Checkpoint Surgical Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Grip Strength at 1 year. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04662320, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.

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