Status:
RECRUITING
Spinal Cord Stimulation for Respiratory Rehabilitation in Patients With Chronic Spinal Cord Injury
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Spinal Cord Injuries
Respiration Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Respiratory complications are among the leading causes of death in patients with chronic spinal cord injury (SCI). Our previous work showed that pulmonary function can be improved by using our origina...
Detailed Description
This is a respiratory rehabilitation-based clinical study consisting of physiologically and functionally relevant mapping of respiratory function that enhances our knowledge of neurophysiological modu...
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
- 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.
Key Trial Info
Start Date :
September 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 10 2030
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06019949
Start Date
September 10 2023
End Date
April 10 2030
Last Update
March 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Frazier Rehabilitation and Neuroscience Institute
Louisville, Kentucky, United States, 40202