NCT06616363 · Virginia Commonwealth University
Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Nat hx With Its Numerous Co-morbidities?
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Richmond, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 26, 2025 · Source of record for eligibility and locations