Improving cough in individuals with acute spinal cord injury using electrical stimulation and muscle training
The Use of Functional Electrical Stimulation in Conjunction With Respiratory Muscle Training to Improve Unaided Cough in Individuals With Acute Spinal Cord Injury
This study tests if using electrical stimulation and muscle training can help people with recent spinal cord injuries improve their ability to cough on their own.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT05745298 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance unaided cough in individuals with acute spinal cord injuries by employing functional electrical stimulation of the abdominal and latissimus dorsi muscles alongside respiratory muscle training. Participants will receive treatment using the Xcite Clinical Station while being monitored for improvements in cough effectiveness. The study focuses on individuals who have sustained spinal cord injuries within the last 12 months and are currently undergoing rehabilitation.
Who should consider this trial
Good fit: Ideal candidates are individuals with traumatic or atraumatic spinal cord injuries at the C2-T12 level who are currently in inpatient rehabilitation.
Not a fit: Patients with concurrent traumatic brain injuries, open tracheostomy, or those unresponsive to electrical stimulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve respiratory function and quality of life for patients with acute spinal cord injuries.
How similar studies have performed: While there is limited information on similar studies, the use of functional electrical stimulation in rehabilitation has shown promise in various contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Traumatic and atraumatic C2- T12 Spinal cord injury (AIS A, B, and C motor incomplete and complete injuries) currently admitted to inpatient rehabilitation with an injury date \< 12 months prior to enrollment 2. Positive response to electrical stimulation through a palpable contraction 3. Fluent in written and spoken English Exclusion Criteria: 1. Individuals who do not meet inclusion criteria 2. Prisoners 3. Concurrent traumatic brain injury determined by Rancho level of cognitive functioning \< VI 4. Individuals with open tracheostomy 5. Persons with pacemakers 6. Pregnant women 7. Persons with epilepsy 8. Open wounds or metal implants at site of electrode placement 9. Unresponsive to functional electrical stimulation 10. Current diagnosis or history of thoraco-abdomino-pelvic cancer
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Stephane Philippe-Ratway, MS, CCC-SLP — University of Miami
- Study coordinator: Gary J Farkas, PhD
- Email: gjf50@med.miami.edu
- Phone: 305-243-4518
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.