Using spinal cord stimulation to improve breathing in patients with spinal cord injuries
Neuromodulatory Rehabilitation for Respiratory Motor Function in Individuals With Chronic Spinal Cord Injury
This study is testing if combining spinal cord stimulation with breathing exercises can help improve lung function in people with spinal cord injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT06019949 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of non-invasive spinal cord stimulation combined with respiratory training on patients with chronic spinal cord injuries. The study aims to enhance pulmonary function by evaluating the neurophysiological modulation induced by spinal cord stimulation. A total of 36 participants will be randomly assigned to one of three groups to receive either respiratory training alone, spinal cord stimulation alone, or a combination of both, followed by assessments before and after 80 intervention sessions. The study will also include a 16-week follow-up period to monitor long-term effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stable, non-progressive spinal cord injuries and significant pulmonary function deficits.
Not a fit: Patients with ongoing psychiatric disorders, significant musculoskeletal issues, or those who are ventilator-dependent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve respiratory function and quality of life for patients with chronic spinal cord injuries.
How similar studies have performed: Previous studies have shown promising results with spinal cord stimulation for respiratory function, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years old; * stable medical condition; * no painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with respiratory training or stimulation; * no clinically significant depression, psychiatric disorders or ongoing drug abuse; * 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; * sustained SCI at least 12 months prior to entering the study; * compared to the normative values for healthy population, at least 15%-deficit in pulmonary function outcomes (FVC and FEV1) as detected by screening spirometry. Exclusion Criteria: Participants will be excluded from the study if there is a presence of * major pulmonary or cardiovascular disease, * ventilator dependence, * endocrine disorders, * malignancy, * marked obesity, * deep vein thrombosis, * HIV/AIDS-related illness, * secondary hypotension (anemia, hypervolemia, endocrine and neurological diseases), * major esophageal/gastrointestinal problem or other major medical illness contraindicated for respiratory training or testing. During screening, the potential participant will be asked whether she is pregnant or planning to become pregnant during the study period. Pregnant women are excluded from this study, as the risk to the fetus is unknown. No pregnancy test or birth control regimen will be required.
Where this trial is running
Louisville, Kentucky
- Frazier Rehabilitation and Neuroscience Institute — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Alexander Ovechkin, MD, PhD — University of Louisville
- Study coordinator: Andrea Willhite, MS
- Email: andrea.willhite@louisville.edu
- Phone: 1-502-581-8675
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.