Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury
Recruiting
N/AInterventional Study
Spinal Cord Injuries
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 50
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
80 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for
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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.
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Eligibility Criteria
Inclusion criteria
* 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 o…
Inclusion criteria
* 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.
* Both individuals with and without currently implanted epidural spinal cord stimulators will be enrolled.
* Twenty uninjured controls will also be enrolled.
Exclusion criteria
* 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.
* Body mass index \>30 kg/m2 for the uninjured controls only given increased risk of prediabetes and potential confounding normative values.
* taking or being administered a medication known to potentially have adverse interactions with phenylephrine
* in the judgement of the principal investigator, any illness or condition that will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
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