Neurostimulation for Respiratory Function After Spinal Cord Injury

Launched by SHIRLEY RYAN ABILITYLAB · Feb 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how to improve breathing in people who have had a cervical spinal cord injury (SCI). The main goal is to understand how stimulating the brain and nerves can help the diaphragm, which is the muscle that helps us breathe. Researchers want to see if combining stimulation therapy with breathing exercises can lead to better respiratory function in these individuals.

To participate, you need to be between 18 and 85 years old and have had your spinal cord injury for at least six months. You should have a specific type of injury at the C1 to C5 levels and show some problems with breathing, like needing a ventilator or having reduced lung capacity. If you join the study, you'll attend up to 55 visits, including about 40 treatment sessions where you’ll receive stimulation and do breathing exercises. It’s important to have a family member or caregiver who can help operate any necessary equipment during these visits. Overall, this trial aims to find new ways to improve the quality of life for those affected by spinal cord injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and females between ages 18-85 years
• • 2. SCI at least 6 months post-injury
• • 3. Spinal Cord injury at C1-C5
• • 4. Demonstrate respiratory deficit following spinal cord injury as following: (1) Individuals using mechanical ventilation, and (2) individuals with pulmonary function testing (PFT) deficits corresponding to having a vital capacity (VC) \< 80% (predicted)
• • 5. Must have a family member or caregiver who is trained and willing to operate the mechanical ventilator during study visits.
• Exclusion Criteria:
• • 1. Any illness or condition that based on the research team's assessment, will compromise with the participant's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.
• • 2. Any debilitating disease prior to the SCI that caused exercise intolerance.
• • 3. Individuals entirely dependent on the support of a diaphragmatic pacer (24 hours per day).
• • 4. Premorbid, ongoing major depression or psychosis, altered cognitive status.
• • 5. History of head injury or stroke
• • 6. Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without a history of seizure, and without anticonvulsant medication
• • 7. History of seizures or epilepsy
• • 8. Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold
• • 9. Pregnant females
• • 10. If a woman of childbearing age is unsure of the pregnancy, and does not want to take the pregnancy test
• • 11. Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, MS, or herniated disk
• • 12. Metal plate in skull
• • 13. Individuals with scalp shrapnel, cochlear implants, or aneurysm clips
• • 14. Individuals taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or PR Interval prolonging drugs