Neurostimulation for Respiratory Function After Spinal Cord Injury (NCT05756894) | Clinical Trial Compass
RecruitingNot Applicable
Neurostimulation for Respiratory Function After Spinal Cord Injury
United States10 participantsStarted 2023-02-28
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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).
What they're measuring
1
Change in Motor evoked potentials (MEPs)
Timeframe: MEPs measured at baseline, 7 weeks (20 sessions), and 14 weeks (40 sessions) of STDP stimulation and respiratory training for the participants during study procedures.
2
Change in Maximum Voluntary Contractions (MVCs)
Timeframe: MVCs measured at baseline, 7 weeks (20 sessions), and 14 weeks (40 sessions) of STDP stimulation and respiratory training for the participants during study procedures.
. 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