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?
- POTS - Postural Orthostatic Tachycardia Syndrome
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Virginia Commonwealth University
- Enrolment target
- 120
- Started
- 29 May 2024
- Main results due
- July 2028
- Study sites
- 1
- Registry updated
- 29 September 2026
Can you take part?
- Ages 12 years to 21 years.
- Women only.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Virginia Commonwealth University
Richmond, Virginia, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06616363. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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