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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 below
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I am between 18 and 50 years old.
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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:
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I have a history of heart disease, high blood pressure, neurological issues (except spinal cord injury), or diabetes.
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I am not pregnant or breastfeeding.
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I am currently on blood thinners.
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I am able to understand and give consent for my participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during laboratory diagnostic testing session
This trial's timeline: 3 weeks for screening, Varies for treatment, and during laboratory diagnostic testing session for reporting.

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 more

Awards & 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
3,343 Previous Clinical Trials
3,062,280 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

Testing of autonomic dysreflexia Clinical Trial Eligibility Overview. Trial Name: NCT04493372 — N/A
Spinal Cord Injury Research Study Groups: Individuals with spinal cord injury, Individuals without spinal cord injury
Spinal Cord Injury Clinical Trial 2023: Testing of autonomic dysreflexia Highlights & Side Effects. Trial Name: NCT04493372 — N/A
Testing of autonomic dysreflexia 2023 Treatment Timeline for Medical Study. Trial Name: NCT04493372 — N/A
~8 spots leftby May 2025
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