Non-Invasive Spinal Cord Stimulation After Injury
Running, not enrolling · Not applicable
Conditions studied: Spinal Cord Injuries
In brief
The goal of this study is to assess the function of the lungs and the muscles are used to breathe after individuals receive respiratory training, spinal cord stimulation, a combination of respiratory training and stimulation, a combination of arm training and stimulation, or a combination of trunk training and stimulation. The respiratory, arm, and trunk training combined with the spinal stimulation interventions are being used to activate the spinal cord below the level of injury. Investigators will be looking for changes in the function of the lungs and trunk muscles before, during, and after these task-specific and non-task-specific interventions for breathing to determine which one has the greatest effect. The results of this study may aid in the development of treatments to help individuals with spinal cord injuries that have impaired lung, arm, and trunk function.
Key facts
- Study ID
- NCT03998527
- Run by
- University of Louisville
- People needed
- 36
- Starts
- 2018-05-17
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-03-13
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- At least 18 years of age at the time of enrollment;
- Stable medical condition;
- Non-progressive SCI T5 or above;
- Sustained SCI at least 12 months prior to enrollment;
- At least a 15% deficit in pulmonary function outcomes (FVC or FEV1) as was detected by screening spirometry
You may not qualify if…
- Untreated musculoskeletal dysfunction;
- Unhealed fracture;
- Untreated contracture or pressure sore;
- Ventilator dependence;
- Untreated depression, psychiatric disorder, or ongoing drug abuse;
- Major pulmonary or cardiovascular disease;
- Major esophageal or gastrointestinal disease;
- Endocrine disorder, malignancy, marked obesity, deep vein thrombosis, or HIV/AIDS related illness;
- Secondary causes of orthostatic hypotension (anemia, hypervolemia, endocrine, or neurological);
- Pregnancy by self-report.
- All Non-Disabled research participants, irrespective of gender, will be selected based on the following:
- Inclusion Criteria:
- At least 21 years of age at the time of enrollment.
- FVC and FEV1 values 80% of predicted or above indicating healthy pulmonary function by screening spirometry.
- Exclusion Criteria:
- History of respiratory disease by self-report,
- History of cardiovascular disease by self-report.
Where it is running
- Frazier Rehabilitation and Neuroscience Institute — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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