Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury
ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorMayo Clinic
About this trial
The purpose of this research is to learn about how the participant's body is able to balance changes in blood pressure, and how spinal cord stimulation affects these changes as well as immune \& cardiovascular function in participants with spinal cord injury.
Eligibility criteria
Qualifiers
Age 18-50.
American Spinal Injury Association Impairment Scale A-D,64 to encompass a representational spectrum of autonomic dysfunction after spinal cord injury.
Neurological level of injury, C6-T8, as defined by the International Standards for Neurological Classification of Spinal Cord Injury.64 Incorporating level of injury over this broad range to capture the spectrum of autonomic dysfunction. Individuals with injuries below T8 will not be included to ensure transcutaneous spinal cord stimulation does not occur over the injury/glial scar, where it may have altered properties. The C6 level was chosen to ensure hand cold pressor stimuli triggers above level sympathetic activation.
Time since injury of greater than six months, given early changes in spinal cord connectivity and recovery prior to this.
Disqualifiers
History of clinically diagnosed cardiovascular disease, diabetes, autonomic neuropathies, neurological disorders (with exception of spinal cord injury for individuals in those cohorts), or are active smokers.
Individuals who are taking betablockers, antihypertensives, or other sympathetically active medications which they are unable to hold.
Women who are pregnant or lactating, given known hormonal influences on autonomic regulation.65,66
Cognitive issues preventing informed consent for participation.
Trial design
Treatments tested in this trial
- Tests of sympathetic inhibition
- Tests of above level sympathetic activation
- Testing of below level sympathetic activation
- Epidural stimulation
- Transcutaneous stimulation
Treatment groups
80 Participants
are divided into 3 treatment groupsLocations
1Mayo Clinic55905, RochesterMinnesota, United States
Sponsors and collaborators
Mayo Clinic
Lead sponsor
Source ClinicalTrials.gov