Using spinal cord stimulation to improve breathing in patients with spinal cord injuries

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.