RECRUITING

Spinal Cord Stimulation and Respiration After 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

Respiratory motor control deficit is the leading cause of morbidity and mortality in patients with spinal cord injury. The long-term goal of this NIH-funded study is to develop a rehabilitation strategy for respiration in patients with spinal cord injury as a standard of care. Respiratory function in patients with chronic spinal cord injury can be improved by using inspiratory-expiratory pressure threshold respiratory training protocol. However, the effectiveness of this intervention is limited by the levels of functional capacity preserved below the neurological level of injury. Preliminary data obtained for this study demonstrate that electrical spinal cord stimulation applied epidurally at the lumbar level in combination with respiratory training can activate and re-organize spinal motor networks for respiration. This study is designed to investigate respiratory motor control-related responses to epidural spinal cord stimulation alone and in combination with respiratory training. By characterization of respiratory muscle activation patterns using surface electromyography in association with pulmonary functional and respiration-related cardiovascular measures, the investigators expect to determine the specific stimulation parameters needed to increase spinal excitability below level of injury to enhance responses to the input from supraspinal centers that remain after injury and to promote the neural plasticity driven by the respiratory training. This hypothesis will be tested by pursuing two Specific Aims: 1) Evaluate the acute effects of epidural spinal cord stimulation on respiratory functional and motor control properties; and 2) Evaluate the effectiveness of epidural spinal cord stimulation combined with respiratory training.

Official Title

Epidural Spinal Cord Stimulation and Respiratory Motor Function After Injury

Quick Facts

Study Start:2021-12-31
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05178056

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 old
  2. * Stable medical condition
  3. * Non-progressive C3-T1 AIS A-C Spinal Cord Injury (SCI)
  4. * Sustained SCI at least 24 months prior to entering the study
  5. * At least 15%-deficit in pulmonary function outcomes
  1. * Painful musculo-skeletal dysfunction
  2. * Unhealed fracture
  3. * Contracture
  4. * Pressure sore
  5. * Urinary tract infection that might interfere with respiratory training
  6. * Clinically significant depression
  7. * Psychiatric disorders
  8. * Ongoing drug abuse;
  9. * Major cardiovascular disease
  10. * Major pulmonary disease
  11. * Ventilator dependence
  12. * Major endocrine disorders
  13. * Malignancy
  14. * Marked obesity
  15. * Deep vein thrombosis
  16. * HIV/AIDS related illness
  17. * Secondary causes of respiratory dysfunction
  18. * Major gastrointestinal problems
  19. * Other major medical illness contraindicated for respiratory training
  20. * Pregnantcy

Contacts and Locations

Study Contact

Alexander Ovechkin, MD, PhD
CONTACT
5025818675
avovec02@louisville.edu
Andrea Willhite, MS
CONTACT
5025818675
andrea.willhite@louisville.edu

Principal Investigator

Alexander Ovechkin, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Louisville

Study Locations (Sites)

Frazier Rehabilitation and Neuroscience Institute
Louisville, Kentucky, 40202
United States

Collaborators and Investigators

Sponsor: University of Louisville

  • Alexander Ovechkin, MD, 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 Date2021-12-31
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2021-12-31
Study Completion Date2030-12-31

Terms related to this study

Keywords Provided by Researchers

  • Epidural Spinal Cord Stimulation
  • Respiratory Training

Additional Relevant MeSH Terms

  • Spinal Cord Injuries
  • Spinal Cord Stimulation
  • Breathing Exercises
  • Rehabilitation