RECRUITING

Task-specific Epidural Stimulation Study

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

The investigators propose to understand the role of lumbosacral spinal cord epidural stimulation (scES) in recovery of autonomic nervous system function, voluntary movement, and standing in individuals with severe spinal cord injury (SCI). Thirty-six individuals with severe SCI who have cardiovascular and respiratory dysfunction and who are unable to voluntarily move the legs or stand will receive scES for cardiovascular function, voluntary movement, or standing with and/or without weight-bearing standing. Training will consist of practicing voluntary movements or standing in the presence of specific scES configurations designed for the voluntary movements of the legs and trunk (Vol-scES), or epidural stimulation configurations specific for standing (Stand-scES). Specific configurations epidural stimulation for cardiovascular function (CV-scES) will be provided during sitting and supine and during maneuvers of orthostatic or cardiovascular stress. The ability to move voluntarily, stand, as well as cardiovascular, respiratory, bladder, bowel and sexual function will be assessed in these individuals with chronic severe spinal cord injury. Quality of life and costs of health care also will be assessed.

Official Title

Task and Physiological Specific Stimulation for Recovery of Autonomic Function, Voluntary Movement, and Standing Using Epidural Stimulation and Training After Severe Spinal Cord Injury

Quick Facts

Study Start:2017-11-08
Study Completion:2024-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03364660

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 18 years of age
  2. * Non-progressive spinal cord injury
  3. * At least 2 years post injury
  4. * Stable medical condition
  5. * Unable to voluntarily move all individual joints of the legs
  6. * Unable to stand independently
  7. * Cardiovascular dysfunction including presence of persistent low blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension and/or dysregulation in response to postural changes and/or highly variable blood pressures in a 24 hour period
  8. * Urodynamic dysfunction including dyssynergia and/or inability to void voluntarily and/or low voiding capacity
  9. * Respiratory dysfunction including at least 15% deficit in predicted pulmonary function outcomes
  1. * Ventilator dependent
  2. * Untreated painful musculoskeletal dysfunction, fracture or pressure sore
  3. * Untreated psychiatric disorder or ongoing drug abuse
  4. * Cardiovascular, respiratory, bladder, or renal disease unrelated to spinal cord injury
  5. * Bladder botox injections less than 12 months prior to implant
  6. * Colostomy bag, urostomy
  7. * Any implanted pump (i.e., baclofen pump, pain pump, etc)
  8. * Ongoing nicotine use
  9. * Pregnant at the time of enrollment or planning to become pregnant during the time course of the study

Contacts and Locations

Study Contact

Susan J Harkema, PhD
CONTACT
502-582-7443
susan.harkema@louisville.edu
Manpreet A Chopra, BAMS
CONTACT
502-582-7443
manpreet.chopra@louisville.edu

Principal Investigator

Susan J Harkema, PhD
PRINCIPAL_INVESTIGATOR
University of Louisville

Study Locations (Sites)

University of Louisville
Louisville, Kentucky, 40202
United States

Collaborators and Investigators

Sponsor: University of Louisville

  • Susan J Harkema, 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 Date2017-11-08
Study Completion Date2024-12-30

Study Record Updates

Study Start Date2017-11-08
Study Completion Date2024-12-30

Terms related to this study

Keywords Provided by Researchers

  • Epidural Stimulation
  • Spinal Cord Injury
  • Task-Specific

Additional Relevant MeSH Terms

  • Spinal Cord Injuries