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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postural Tachycardia Syndrome
• Intervention / Treatment: Behavioral: Looming task

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gisela Chelimsky, M.D.; Phone Number: (804) 628-0145; Email: gisela.chelimsky@vcuhealth.org
• Study Contact Backup: Name: Madison Maxwell, B.S.; Email: madison.maxwell@vcuhealth.org

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Adolescents with POTS	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.
Other: Adolescents without POTS	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Gisela Chelimsky, M.D., Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Autonomic Nervous System Diseases; Primary Dysautonomias; Orthostatic Intolerance; Tachycardia; Postural Orthostatic Tachycardia Syndrome
• Other Study ID Numbers: HM20025242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No