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Autonomic Function Testing for Spinal Cord Injury
N/A
Recruiting
Led By Ryan Solinsky, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All subjects must be aged 18-50 years old.
Participants with spinal cord injury must have adult onset, traumatic spinal cord injury.
Must not have
History of cardiovascular disease, hypertension, neurologic disorders (with exception of spinal cord injury), or diabetes.
Women who are pregnant or lactating.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, prior to laboratory diagnostic testing session
Awards & highlights
No Placebo-Only Group
Summary
This trial looks to understand how different degrees of dysfunction in the autonomic nervous system after spinal cord injury relate to secondary autonomic complications.
Who is the study for?
This trial is for adults aged 18-50 with adult onset, traumatic spinal cord injury that occurred 1-5 years ago. They should have a range of autonomic dysfunction (American Spinal Injury Association Impairment Scale A-D) and injuries at the C1-T12 level. Exclusions include blood thinners use, incompatible implants with MRI, pregnancy, lactation, cognitive issues preventing consent, BMI >30 kg/m2 for controls only.
What is being tested?
The study tests how well the autonomic nervous system functions after spinal cord injury by measuring blood pressure regulation and other responses. It includes lab tests to assess signal inhibition/activation in participants with injuries versus uninjured controls, smart watch monitoring at home for heart rate and skin temperature data, and MRI scans to analyze spinal cord connectivity patterns.
What are the potential side effects?
Since this trial involves non-invasive testing methods like sympathetic activation/inhibition tests and imaging-based assessments rather than drug interventions or surgeries, side effects are minimal but may include discomfort from wearing devices or during testing procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old.
Select...
My spinal cord injury was caused by trauma as an adult.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of heart disease, high blood pressure, neurological issues (except spinal cord injury), or diabetes.
Select...
I am not pregnant or breastfeeding.
Select...
I am currently on blood thinners.
Select...
I am able to understand and give consent for my participation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during laboratory diagnostic testing session
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during laboratory diagnostic testing session
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Valsalva Maneuver Phase II
Secondary study objectives
Beat-to-beat blood pressure
Beat-to-beat heart rate
Continuous galvanic skin response
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Individuals without spinal cord injuryExperimental Treatment3 Interventions
Group II: Individuals with spinal cord injuryExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testing of autonomic dysreflexia
2022
N/A
~10
Tests of sympathetic activation
2022
N/A
~10
Tests of sympathetic inhibition
2022
N/A
~10
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,349 Previous Clinical Trials
3,061,027 Total Patients Enrolled
Spaulding Rehabilitation HospitalLead Sponsor
139 Previous Clinical Trials
11,032 Total Patients Enrolled
Ryan Solinsky, MDPrincipal Investigator - Mayo Clinic
Spaulding Rehabilitation Hospital
1 Previous Clinical Trials
4 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding.If you have a spinal cord injury, it must be classified as A-D on the American Spinal Injury Association Impairment Scale, which measures the severity of your injury.I am able to understand and give consent for my participation.If you have a spinal cord injury, it must be at a certain level defined by specific guidelines.My spinal cord injury was caused by trauma as an adult.I am currently on blood thinners.I am between 18 and 50 years old.My injury occurred between 1 and 5 years ago.You have a body mass index (BMI) greater than 30, which may affect the study's ability to understand the impact of spinal cord injury on heart disease and diabetes.I have a history of heart disease, high blood pressure, neurological issues (except spinal cord injury), or diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Individuals with spinal cord injury
- Group 2: Individuals without spinal cord injury
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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