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

NCT05618054 | Recruiting

• 1 other identifier: HM20025242
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postural Tachycardia Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Adolescents with POTS

OTHER

Behavioral: Looming task

Adolescents without POTS

OTHER

Behavioral: Looming task

Interventions

Looming task BEHAVIORAL

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.

Adolescents with POTS; Adolescents without POTS

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Study Officials

• Gisela Chelimsky, M.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gisela Chelimsky, M.D.

CONTACT

(804) 628-0145; gisela.chelimsky@vcuhealth.org

Madison Maxwell, B.S.

CONTACT

madison.maxwell@vcuhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 16, 2022
• Study Start: March 6, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)