Neurostimulation for Respiratory Function After Spinal Cord Injury
Pilot Study: Spike-timing-dependent Plasticity for Respiratory Function After Spinal Cord Injury
Shirley Ryan AbilityLab
10 participants
Feb 28, 2023
INTERVENTIONAL
Conditions
Summary
The purpose of this research study is to learn more about the connections between the brain, nerves, and diaphragm after experiencing a cervical spinal cord injury (SCI).The main question it aims to answer is: Changes in respiratory function and recovery using stimulation and respiratory exercise training in spinal cord-injured individuals. Participants will complete a maximum of 55 study visits. They will be asked to complete about 40 treatment sessions which include multiple stimulation sessions over the scalp and neck, followed by about 60 minutes of respiratory training. Assessment sessions will be completed prior at baseline, after 20 sessions and after 40 sessions of study treatment.
Eligibility
Inclusion Criteria5
- Male and females between ages 18-85 years
- SCI at least 6 months post-injury
- Spinal Cord injury at C1-C5
- 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)
- Must have a family member or caregiver who is trained and willing to operate the mechanical ventilator during study visits.
Exclusion Criteria14
- 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.
- Any debilitating disease prior to the SCI that caused exercise intolerance.
- Individuals entirely dependent on the support of a diaphragmatic pacer (24 hours per day).
- Premorbid, ongoing major depression or psychosis, altered cognitive status.
- History of head injury or stroke
- Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without a history of seizure, and without anticonvulsant medication
- History of seizures or epilepsy
- Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold
- Pregnant females
- If a woman of childbearing age is unsure of the pregnancy, and does not want to take the pregnancy test
- 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
- Metal plate in skull
- Individuals with scalp shrapnel, cochlear implants, or aneurysm clips
- Individuals taking Bupropion, Dolutegravir, Lacosamide, Trilaciclib, or PR Interval prolonging drugs
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Interventions
Paired stimulation will be given to the spinal cord and to peripheral nerves so that the signals are received at the spinal cord at a specific interval.
Respiratory exercises will be completed immediately after completing neurostimulation. Respiratory exercises will involve inspiratory muscle training performing four sets of 6-10 breaths per day with two minutes of rest.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05756894