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Autonomic Function Testing for Spinal Cord Injury

N/A
Waitlist Available
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, prior to laboratory diagnostic testing session
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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My injury occurred between 1 and 5 years ago.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Valsalva Maneuver Phase II
Secondary outcome measures
Beat-to-beat blood pressure
Beat-to-beat heart rate
Continuous galvanic skin response
+3 more

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
3,176 Previous Clinical Trials
3,757,982 Total Patients Enrolled
Spaulding Rehabilitation HospitalLead Sponsor
133 Previous Clinical Trials
10,954 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I become involved in this research project?

"Up to 69 individuals with autonomic dysreflexia that are between 18-50 years old can participate in this study. The most vital requirement for applicants is that they meet the following qualifications:- age 18-50 years old., All subjects, Participants with spinal cord injury, Time since injury restricted to 1-5 years, in an effort to limit baroreflex desensitization., Neurological level of injury, C1-T12, as defined by the International Standards for Neurological Classification of Spinal Cord Injury. Incorporating level of injury down to T12 to encompass a broad range of autonomic dysfunction."

Answered by AI

How many people are being given the chance to try this new medication?

"That is correct. The trial, which was posted on November 13th 2020, according to clinicaltrials.gov, is currently looking for 69 individuals from 1 location."

Answered by AI

Would this research be available to people who are elderly?

"This trial is only enrolling patients that are aged between 18 and 50."

Answered by AI

Are there any current vacancies for this research project?

"The study is still open and looking for participants, according to the information available on clinicaltrials.gov. This research was originally posted on November 13th 2020, with the most recent update being June 20th 2022."

Answered by AI
~11 spots leftby Dec 2024