Neurostimulation to improve breathing after spinal cord injury
Pilot Study: Spike-timing-dependent Plasticity for Respiratory Function After Spinal Cord Injury
This study is testing if a new type of brain stimulation can help people with cervical spinal cord injuries breathe better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05756894 on ClinicalTrials.gov |
What this trial studies
This research aims to explore the connections between the brain, nerves, and diaphragm in individuals with cervical spinal cord injuries. Participants will undergo a series of neurostimulation sessions followed by respiratory training to assess improvements in respiratory function. The study will involve up to 55 visits, including baseline assessments and evaluations after treatment sessions. The goal is to utilize spike-timing-dependent plasticity to enhance respiratory function in those affected by high cervical spinal cord injuries.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with a cervical spinal cord injury at C1-C5 and respiratory deficits.
Not a fit: Patients who are entirely dependent on a diaphragmatic pacer or have severe comorbid conditions 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 high cervical spinal cord injuries.
How similar studies have performed: While similar approaches have shown promise in improving motor functions, this specific application of neurostimulation for respiratory function in high cervical SCI is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- Shirley Ryan Ability Lab — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Monica A Perez, PT, PhD — Shirley Ryan AbilityLab
- Study coordinator: Monica A Perez, PT, PhD
- Email: mperez04@sralab.org
- Phone: 3122382886
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.