RECRUITING

Spinal Cord Stimulation for Respiratory Rehabilitation in Patients With Chronic 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

Respiratory complications are among the leading causes of death in patients with chronic spinal cord injury (SCI). Our previous work showed that pulmonary function can be improved by using our original respiratory training method. However, the effectiveness of this intervention is limited due to the disruption of brain-spinal connections and consequently lowered spinal cord activity below the injury level. Our recent studies showed that electrical stimulation of the spinal cord below the level of injury leads to increased ventilation which indicates activation of the spinal cord structures related to respiration. These findings indicate that spinal cord stimulation can be a promising therapeutic additive to the treatment. The goal of this study is to justify the establishment of a new direction in rehabilitation for patients with SCI by using a non-invasive spinal cord stimulation in combination with respiratory training. Our aims are: 1) to evaluate the effects of such stimulation applied to the injured spinal cord on pulmonary function and respiratory muscle activity, and 2) to evaluate the effectiveness and therapeutic mechanisms of the spinal cord stimulation combined with respiratory training. Thirty-six individuals with chronic SCI will be recruited and assigned to three groups to receive respiratory training or spinal cord stimulation alone or a combination of them. All participants will be tested before and after cycles of experimental procedures with/or without stimulation. Our hypotheses will be confirmed if the respiratory training combined with spinal cord stimulation results in the most enhanced positive effects.

Official Title

Neuromodulatory Rehabilitation for Respiratory Motor Function in Individuals With Chronic Spinal Cord Injury

Quick Facts

Study Start:2023-09-10
Study Completion:2030-04-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06019949

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. * no painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with respiratory training or stimulation;
  4. * no clinically significant depression, psychiatric disorders or ongoing drug abuse;
  5. * non-progressive SCI (no negative change in the neurological level and motor-completeness assessed during screening when compared to the neurological status assessed at 6-mo period after injury or at least 6 months prior to the screening), non-ventilator dependence, motor-complete SCI according to the American Spinal Injury Association Impairment Scale (AIS) grade "A" or "B" above T5 spinal level;
  6. * sustained SCI at least 12 months prior to entering the study;
  7. * compared to the normative values for healthy population, at least 15%-deficit in pulmonary function outcomes (FVC and FEV1) as detected by screening spirometry.
  1. * major pulmonary or cardiovascular disease,
  2. * ventilator dependence,
  3. * endocrine disorders,
  4. * malignancy,
  5. * marked obesity,
  6. * deep vein thrombosis,
  7. * HIV/AIDS-related illness,
  8. * secondary hypotension (anemia, hypervolemia, endocrine and neurological diseases),
  9. * major esophageal/gastrointestinal problem or other major medical illness contraindicated for respiratory training or testing.

Contacts and Locations

Study Contact

Andrea Willhite, MS
CONTACT
1-502-581-8675
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 Date2023-09-10
Study Completion Date2030-04-10

Study Record Updates

Study Start Date2023-09-10
Study Completion Date2030-04-10

Terms related to this study

Keywords Provided by Researchers

  • Spinal Cord Injury
  • Respiration
  • Rehabilitation

Additional Relevant MeSH Terms

  • Spinal Cord Injuries
  • Respiration Disorders