Non-invasive breathing therapies to improve respiratory function after chronic spinal cord injury
Non-Invasive Interventions and Biomarker Identification for Respiratory Recovery in Chronic Spinal Cord Injury
We will try combining non-invasive spinal electrical stimulation and brief high-carbon-dioxide breathing with respiratory resistance exercises to see if they improve breathing in adults with chronic incomplete spinal cord injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07135583 on ClinicalTrials.gov |
What this trial studies
This single-site, interventional crossover trial tests whether four consecutive days of combined hypercapnic-intermittent hypoxia (HiCO2-AIH) and transcutaneous spinal cord stimulation (tSCS) enhances the effect of respiratory resistance training in adults with chronic incomplete cervical or thoracic SCI. Using a Williams crossover design, up to 20 participants (target n=16 after accounting for dropout) will receive the combined intervention, each single intervention alone, and respiratory resistance exercise alone across separate treatment periods. The primary outcome is change in mouth occlusion pressure at 0.1 seconds (P0.1) measured from before to one day after intervention, with secondary outcomes including maximal inspiratory and expiratory pressures, forced vital capacity, and diaphragm neurophysiology measured by TMS and cervical magnetic stimulation. The study will also collect blood and genetic biomarkers to explore predictors of response and will continuously monitor respiratory and cardiovascular safety parameters during interventions.
Who should consider this trial
Good fit: Adults 18–70 with chronic (≥1 year) incomplete spinal cord injury at or below C-3 to T-8 who are medically stable, have non-progressive injury, and show greater than 20% impairment in maximal inspiratory or expiratory pressure are the intended participants.
Not a fit: People with complete diaphragm paralysis, active cardiovascular or lung disease, uncontrolled autonomic dysreflexia, recent infections or non-healing wounds, pregnancy, seizure disorders, or other listed exclusion conditions are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could strengthen breathing drive and muscle function, reduce respiratory complications, and improve quality of life for people with chronic incomplete SCI.
How similar studies have performed: Prior small studies of intermittent hypoxia and spinal stimulation have shown promise for improving motor and some respiratory outcomes after SCI, but combining HiCO2-AIH with tSCS for respiratory training is novel and not yet established in larger trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. adults 18 to 70 years of age (the latter to reduce likelihood of cardiovascular disease); 2. chronic SCI for ≥ 1 year at or below C-3 to T-8 3. incomplete SCI based on classification of incomplete-B, C or D 4. medically stable with clearance from physician 5. SCI due to non-progressive etiology 6. \>20% impairment in maximal inspiratory or expiratory pressure generation Exclusion Criteria: * Individuals will be excluded due to (1) current diagnosis of an additional neurologic condition (eg. multiple sclerosis or stroke) (2) loss of diaphragm EMG activity on forced respiratory tests; (3) severe illness or infection (4) non-healing decubitus ulcers (5) untreated bladder or urinary infections (6) cardiovascular disease (7) lung disease (8) active heterotopic ossification (9) uncontrolled hypertension; (10) severe neuropathic pain; (11) pregnancy (5) severe recurrent and uncontrolled autonomic dysreflexia (6) history of seizure disorder.
Where this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University Center City Campus — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jay Nair, PT, PhD — Thomas Jefferson University
- Study coordinator: Jay Nair, PT, PhD
- Email: nairlab@jefferson.edu
- Phone: 13528715888
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.