RECRUITING

Transcutaneous Spinal Stimulation: Safety and Feasibility for Upper Limb Function in Children With Spinal Cord Injury

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

Children who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and/or weakness of their arms and hand muscles. The purpose of this project is to test the safety, comfort, and practicality of a new therapy that stimulates the spinal cord to facilitate activation of arm and hand muscles while practicing grasping, pinching, and reaching movements. The long-term goal is to provide better therapies that will improve the ability of children with SCI to more successfully play and accomplish everyday tasks using their arms and hands, similar to before their injury.

Official Title

Transcutaneous Spinal Stimulation Promoting Recovery of Hand and Arm Function After Pediatric-onset Spinal Cord Injury

Quick Facts

Study Start:2019-11-14
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04032990

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:4 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * history of chronic, acquired SCI, (\>1 year since injury);
  2. * SCI involves cervical and/or high thoracic (T1) levels
  3. * moderate to severe upper extremity deficit as assessed by the Pediatric Neuromuscular Recovery Upper Extremity Scale (scores less than 4A out of a 12 point range from 1A-4C on upper extremity tasks, e.g. including inability to fully reach overhead, grasp, or pinch without compensation)
  4. * discharged from in-patient rehabilitation
  1. * botox use within past 3 months;
  2. * current baclofen use
  3. * unhealed upper extremity fracture
  4. * any other medical complication limiting participation in the assessments and/or activity- based upper extremity training;
  5. * congenital SCI
  6. * total ventilator dependence

Contacts and Locations

Study Contact

Lisa Clayton, B.S.
CONTACT
502-333-8152
Lisa.Clayton@louisville.edu

Principal Investigator

Andrea L Behrman, PT, PhD
PRINCIPAL_INVESTIGATOR
University of Louisville

Study Locations (Sites)

Department of Neurosurgery
Louisville, Kentucky, 40202
United States

Collaborators and Investigators

Sponsor: University of Louisville

  • Andrea L Behrman, PT, PhD, PRINCIPAL_INVESTIGATOR, University of Louisville

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 Date2019-11-14
Study Completion Date2026-02

Study Record Updates

Study Start Date2019-11-14
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • pediatric-onset
  • transcutaneous spinal stimulation
  • upper extremity function

Additional Relevant MeSH Terms

  • Spinal Cord Injuries