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New treatment option for Spinal Cord Injuries
Official title Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury
ClinicalTrials.gov ID: NCT07210411
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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.
You likely can't join if
- History of clinically diagnosed cardiovascular disease, diabetes, autonomic neuropathies, neurological disorders (with exception of spinal cord...
- 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
See the full eligibility 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...
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.