NCT06019949
Spinal Cord Stimulation for Respiratory Rehabilitation in Patients With Chronic Spinal Cord Injury
Recruiting
NAAges 18+InterventionalTreatmentUniversity of LouisvilleInvestigator-initiated
~36 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:Transcutaneous spinal cord stimulatorRespiratory Training
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Expiratory Pressure (PEmax).
Measured over Within 2 weeks during screening period; within 4 weeks before an intervention period; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after 16-weeks and 32-weeks follow-up periods.
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesKentucky1
Study leadership
- Alexander Ovechkin, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Louisville
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- Maximum Expiratory Pressure (PEmax).Within 2 weeks during screening period; within 4 weeks before an intervention period; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after 16-weeks and 32-weeks follow-up periods.
Standard Spirometry measurement.
- Maximum Inspiratory Pressure (PImax).Within 2 weeks during screening period; within 4 weeks before an intervention period; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after 16-weeks and 32-weeks follow-up periods.
Standard Spirometry measurement.
- Surface electromyography (sEMG) Similarity Index (SI)Within 4 weeks before an intervention period; within 2 weeks after intervention #40; within 2 weeks after intervention #80; within 2 weeks after 16-weeks and 32-weeks follow-up periods.
Respiratory multi-muscle activation measures assessed using standard surface electromyography.