Neurostimulation to improve breathing after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using a brain-computer interface to help people with tetraplegia communicate

  This study is testing a new brain-computer interface to help people with tetraplegia communicate more easily using a tablet.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT06511934

• Using epidural stimulation to improve rehabilitation outcomes for cervical spinal cord injuries

  This study is testing if a new treatment using epidural stimulation along with arm exercises can help people with cervical spinal cord injuries improve their arm function.

  Recruiting The Methodist Hospital Research Institute · Houston, Texas · NCT06225245

• Transcutaneous spinal cord stimulation with 4-aminopyridine and intensive rehab for chronic spinal cord injury

  This pilot study tests whether combining noninvasive spinal stimulation, dalfampridine, and rigorous rehab is safe and feasible for adults with chronic spinal cord injury and whether it can help improve movement and walking.

  Recruiting TryAbility LLC · Downers Grove, Illinois · NCT07922122

• NG004 for incomplete cervical spinal cord injury

  This trial tests NG004 versus placebo to see if it is safe and helps motor function and daily life in adults with acute incomplete cervical spinal cord injury.

  Recruiting at 7 sites Phase 1 NovaGo Therapeutics AG · Bayreuth and 9 other locations · NCT07840196

• Robot-assisted training for arm and leg movement after stroke or injury

  This study tests whether adding ZEPU-AI robotic training to usual therapy is safe and helps adults with arm or leg movement problems from stroke, spinal cord injury, brain injury, or orthopedic conditions.

  Recruiting Bangladesh Medical University · Dhaka · NCT07749625

• ZEPU-AI3 Lower Limb Feedback Training and Evaluation Robot in Rehab

  This pilot trial tests whether adding the ZEPU-AI3 robotic leg training with real-time feedback to standard rehab helps adults with lower limb motor problems from stroke, spinal cord injury, or similar conditions.

  Recruiting Bangladesh Medical University · Dhaka, Dhaka Division · NCT07705906

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.