Non-invasive breathing therapies to improve respiratory function after chronic spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.