Neurostimulation for Respiratory Function After Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShirley Ryan AbilityLab
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Neurostimulation
- Repiratory training
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov