Biomarkers for Autonomic Dysreflexia
T
Thomas Everett
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
N/A
10 participants needed
1 Location
Brief description of study
What is this study about?
The purpose of this study is to investigate if the onset of autonomic dysreflexia can be detected before the presentation of symptoms occurs. This will include measuring nerve activity from the skin, blood pressure, heart rate, and skin temperature.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Subjects will be identified through the Urology clinics at specified institutions. They will be referred to the PI for the study if they are a candidate. Patients will be approached for consent after the PI or treating physician determines they could be eligible for the study.
Detailed description of study
What Will Happen During Study Participation?
- If you agree to be in the study, you will undergo a urodynamic testing procedure and allow the collection of continuous ECG, nerve recordings from your skin, and skin temperature during your procedure. These recordings will be obtained from standard electrodes that will be placed on the skin and from a smart watch that you will wear on your wrist. As part of the urodynamic testing, a catheter will be placed in your bladder and your bladder will be filled with saline, which commonly induces autonomic dysreflexia in persons with tetraplegia. The saline will be immediately drained from your bladder once you experience symptoms of autonomic dysreflexia. This testing could take up to a maximum of 30-45 minutes.
- One symptom of autonomic dysreflexia is an increase in blood pressure. While this typically improves after draining the bladder or changing position, this symptom may persist. If symptoms of high blood pressure persist after draining your bladder and changing position, you may be given Nifedipine (10 mg tablet) to return your blood pressure to normal range.
- You will be asked to self-report the symptoms that you feel. We will also ask you to complete questionnaires afterward regarding symptoms you’ve experienced. We will also be collecting information from your medical records. This will help us to understand the nerve recordings that will be making.
- The total time these procedures will take will be approximately 1 hour and 30 minutes.
Is there incentive/compensation for participating?
Participants will receive $150 and a parking pass for participating in this study.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Autonomic dysreflexia, Chronic spinal cord injury
-
Age: 18 years - 100 years
-
Gender: All
Inclusion criteria
• Have chronic spinal cord injuries (> 1 year post-injury) above the T6 level.
• Be familiar with their symptoms of AD and management strategies.
• Have experienced AD symptoms due to bladder or bowel management problems and answers 1 or higher on ADFSCI questions regarding AD symptoms either during bladder emptying or during their bowel routine.
Exclusion criteria:
• Pacemaker dependent
o Pacing artifacts prevents skNA analyses
• Chronic heart disease including chronic heart failure and chronic arrhythmias
• Allergic to skin patch electrodes
• Diabetes
• Unstable psychiatric condition or any cognitive dysfunction
• Current employees, student or trainee of the Krannert Cardiovascular Research Center
o Vulnerable population
• Have chronic spinal cord injuries (> 1 year post-injury) above the T6 level.
• Be familiar with their symptoms of AD and management strategies.
• Have experienced AD symptoms due to bladder or bowel management problems and answers 1 or higher on ADFSCI questions regarding AD symptoms either during bladder emptying or during their bowel routine.
Exclusion criteria:
• Pacemaker dependent
o Pacing artifacts prevents skNA analyses
• Chronic heart disease including chronic heart failure and chronic arrhythmias
• Allergic to skin patch electrodes
• Diabetes
• Unstable psychiatric condition or any cognitive dysfunction
• Current employees, student or trainee of the Krannert Cardiovascular Research Center
o Vulnerable population
Updated on
09 Apr 2025.
Study ID: KIC-IIR-EVERETT-SKNA-UROLOGY, 10931
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