RECRUITING

Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Promoting Healing of Injured Nerves With Electrical Stimulation Therapy

Quick Facts

Study Start:2023-06-12
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05884125

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Upper extremity mixed or motor nerve injury from the brachial plexus to the wrist crease.
  2. * Candidate for surgical intervention.
  3. * Indicated for surgical repair by nerve transfer, primary repair, or nerve grafting.
  4. * Are age 18-80 years.
  5. * Signed and dated informed consent form.
  1. * Severe comorbid condition, such as arrhythmia or congestive heart failure, preventing surgery.
  2. * Primary repair requiring graft \>6cm.
  3. * Nerve reconstruction occurring \>12 months post injury.
  4. * Age less than 18 or greater than 80 years.
  5. * All contraindications to included/required surgical procedure, including but not limited to language barriers, mental status barriers, inability to consent, and pregnancy/lactation.

Contacts and Locations

Study Contact

Eric Walker, PhD
CONTACT
216-370-9107
ewalker@checkpointsurgical.com

Principal Investigator

Amy M Moore, MD
PRINCIPAL_INVESTIGATOR
Ohio State University

Study Locations (Sites)

The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery
Columbus, Ohio, 43212
United States

Collaborators and Investigators

Sponsor: Checkpoint Surgical Inc.

  • Amy M Moore, MD, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-12
Study Completion Date2027-06

Study Record Updates

Study Start Date2023-06-12
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • Therapeutic Electrical Stimulation
  • Brief Electrical Stimulation
  • Nerve Regeneration
  • Nerve Injury
  • Nerve Healing
  • Nerve Repair

Additional Relevant MeSH Terms

  • Nerve Injury
  • Peripheral Nerve Injuries
  • Peripheral Nerve Injury Upper Limb
  • Nerve Palsy