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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05618054
Other study ID # HM20025242
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 6, 2023
Est. completion date May 2025

Study information

Verified date January 2024
Source Virginia Commonwealth University
Contact Gisela Chelimsky, M.D.
Phone (804) 628-0145
Email gisela.chelimsky@vcuhealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is being conducted to see how people with Postural tachycardia syndrome (POTS) make sense of the things they see. The information may help doctors to learn more about how the different parts of people's brains communicate.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date May 2025
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 12 Years to 21 Years
Eligibility Inclusion Criteria: - Females 12-21 years old - Able to communicate and provide consent/assent - English speaking - Diagnosed with POTS (POTS will be defined standardly as a symptomatic = 40 bpm rise in heart rate without a drop in blood pressure and with symptoms of orthostatic intolerance clinically) - Age-matched healthy control subjects: no POTS or other neurological disorders Exclusion Criteria: - Inflammatory arthritis, connective tissue or auto-immune disorder - Any chronic neurological disorder besides POTS - Evidence of unstable medical disorder, such as kidney (rising creatinine, or end-stage renal failure) or liver impairment (rising AST or ALT, or end-stage with coagulopathy), poorly controlled significant cardiovascular (CHF), respiratory, endocrine (diabetes - A1c > 9 - or untreated thyroid dysfunction) or uncontrolled psychiatric illness (such as untreated depression, psychosis, etc.) - Neuropathy, central nervous system disorder (e.g., Cerebral palsy, developmental delay, seizure disorder, MS, stroke, etc.) - Treatment with a drug or medical device within the previous 30 days that has not received regulatory approval - Use of hormones (except insulin, thyroid replacement or oral contraceptives, which will be carefully documented) - Current substance or alcohol abuse - Any major surgical intervention with general anesthesia in the last 60 days and minor procedure, such as tooth extraction, endoscopy, etc., with local or conscious sedation within 7 days - Any on-going or pending medical, health or disability related litigation, or current pursuit of disability - Any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which would clearly confound the interpretation of the study results (specific reason will be documented) - Chronic use of narcotics for pain - Claustrophobia or any metal hardware that may interfere with MRI - Investigators and study staff

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Looming task
Participants will be asked to look at some pictures during an fMRI scan. Participants will press a button as soon as they see the image appear.

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Periaqueductal gray region activation - looming task Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region during the looming task 90 minutes
Primary Periaqueductal gray region activation - resting Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region while at rest 90 minutes
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