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Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Nat hx With Its Numerous Co-morbidities?
(PAG POTS - NIH) Pediatric Postural Orthostatic Tachycardia Syndrome (POTS) : Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?
Who can join
Ages 12 to 21 · Women · Healthy volunteers welcome
Full eligibility criteria
POTS sample Inclusion Criteria: * symptomatic ≥ 40 bpm rise in heart rate in the first 10 min of a tilt table study without a drop in blood pressure * Clinical symptoms of orthostatic intolerance Exclusion Criteria: * Pregnant or breastfeeding * Cognitive defects that preclude answering questionnaires or following assessment directions * Other chronic diseases * Unstable medical conditions * Use of narcotics * Limited English proficiency * Investigator discretion that participant would not be suitable to participate * A phone older than 5 years old or unable to support EMA software POST INFECTION Inclusion Criteria: * acute upper respiratory or gastrointestinal infection that required admission to the acute care units but not requiring an ICU stay Exclusion Criteria: * Pregnant or breastfeeding * Chronic prescriptions, history of POTS or orthostatic symptoms, recent inpatient psychiatric admissions, substance use disorder, trauma such as a motor vehicle accident, surgery, or other significant physical or emotional trauma in the last 5 years * Cognitive defects that preclude answering questionnaires or following assessment directions * Other unstable chronic diseases * Unstable medical conditions * Use of narcotics * Severe depression or anxiety (untreated / unstable) * Limited English proficiency * Investigator discretion that participant would not be suitable to participate * A phone older than 5 years old or unable to support EMA software HEALTHY CONTROLS Inclusion Criteria: * Apparently healthy with no known chronic illnesses Exclusion Criteria: * Pregnant or breastfeeding * History of POTS or orthostatic symptoms, migraines, fibromyalgia, chronic fatigue, PTSD. Functional gastrointestinal disorders, fainting, dysmenorrhea, or other chronic pain syndrome, inpatient psychiatric admissions, substance use disorder, trauma such as a motor vehicle accident, surgery, or other significant physical or emotional trauma in the last 5 years * Cognitive defects that preclude answering questionnaires or following assessment directions * Other chronic unstable diseases * Unstable medical conditions * Use of narcotics * Severe depression or anxiety (untreated / unstable) * Limited English proficiency * Investigator discretion that participant would not be suitable to participate * A phone older than 5 years old or unable to support EMA software
About the study
Postural tachycardia syndrome (POTS) is a common and disabling disorder among adolescents. No epidemiologic data exist to support the often cited 0.5 to 2% prevalence. Case series suggest 3 to 5 times greater incidence in girls than boys. POTS is defined in children as daily chronic symptoms of orthostatic intolerance and a 40 bpm rise in heart rate in the first 10 minutes of a tilt study in the absence of orthostatic hypotension. POTS often develops after an acute event like an illness, infection, immunization, head trauma, psychological trauma or surgery. Natural history data are absent for POTS, though some outcome studies exist. Orthostatic symptoms improve in the majority and heart rate changes improve in 38% at 1 year. A 2-year follow up showed small improvement in comorbid symptoms of POTS in a 12 subject cohort followed yearly. In a pediatric 5-year outcome follow up questionnaire study, 86% of adolescents with POTS reported resolved, improved, or intermittent, symptoms, with primarily physical rather than mental health complaints.
What is being tested
- Questionnaires to be competed (behavioral)
- Provide list of medication and lifetime events (behavioral)
- Use phone App to record new life events (behavioral)
- Will wear an activity monitor (device)
- Periodic 24-hour urine sodium check (other)
- A fMRI scan (diagnostic test)
Sponsor: Virginia Commonwealth University · Participants: 120 · Started: May 29, 2024
Contact the study team
- Gisela Chelimsky · Phone: 804-827-3427
- Bhakti Dave · Phone: 804-827-3427
Official record on ClinicalTrials.gov — NCT06616363
Locations in the U.S.
| Virginia | Virginia Commonwealth University, Richmond |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.