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Active, Not Recruiting

NCT Number: NCT04662320

Promoting Healing of Nerves Through Electrical Stimulation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cubital Tunnel Syndrome Cumulative Trauma Disorders Mononeuropathies Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nerve Compression Nerve Compression Syndromes Nerve Injury Nerve Sheath Neoplasms Nervous System Diseases Neuroma Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Ulnar Nerve Compression Syndromes Ulnar Neuropathies Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Stanford, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Checkpoint BEST System

Device

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 names: Brief Electrical Stimulation (BES) Therapy

Primary outcomes

  1. Change in Grip Strength at 1 year.

    Time frame: 1 year

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

Secondary outcomes

  1. Grip Strength

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

    Maximum grip strength

  2. Lateral Pinch Strength

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

    Maximum lateral pinch strength

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Nerve Conduction Velocity (NCV)

    Time frame: Pre-surgery, 3 months, and 7 months

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

  11. Electromyography (EMG)

    Time frame: Pre-surgery, 3 months, and 7 months

    Measurement of the electrical activity in a muscle.

Sponsors and collaborators

Lead sponsor

Checkpoint Surgical Inc.

Industry

Collaborators

  • Congressionally Directed Medical Research Programs

Registry information

Acronym: PHONES

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2020
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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