Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?

Postural Tachycardia Syndrome Clinical Trial

Official title:

Pediatric POTS: Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05618054
• Other study ID #: HM20025242
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Postural Orthostatic Tachycardia Syndrome
• Postural Tachycardia Syndrome
• Tachycardia

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