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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?

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05618054
Enrollment
36
Registered
2022-11-16
Start date
2023-03-06
Completion date
2026-12-01
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postural Tachycardia Syndrome

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.

Interventions

BEHAVIORALLooming 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.

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 21 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Periaqueductal gray region activation - looming task90 minutesFunctional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region during the looming task
Periaqueductal gray region activation - resting90 minutesFunctional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region while at rest

Countries

United States

Contacts

CONTACTGisela Chelimsky, M.D.
gisela.chelimsky@vcuhealth.org(804) 628-0145
CONTACTMadison Maxwell, B.S.
madison.maxwell@vcuhealth.org
PRINCIPAL_INVESTIGATORGisela Chelimsky, M.D.

Virginia Commonwealth University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026