Actively Recruiting
Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Nat hx With Its Numerous Co-morbidities?
Led by Virginia Commonwealth University · Updated on 2025-09-26
120
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Nat hx With Its Numerous Co-morbidities?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic with a 40 bpm or greater rise in heart rate within 10 minutes of a tilt table test without blood pressure drop
- Clinical symptoms of orthostatic intolerance
- For post-infection group: acute upper respiratory or gastrointestinal infection requiring acute care admission but not ICU
- For healthy controls: apparently healthy with no known chronic illnesses
- Female participants aged 12 to 21 years
You will not qualify if you...
- Pregnant or breastfeeding
- Cognitive impairments preventing questionnaire completion or following study directions
- Presence of other chronic or unstable medical conditions
- Use of narcotics
- Limited English proficiency
- Investigator judgment deeming participant unsuitable
- Use of a phone older than 5 years or unable to support the required app
- For post-infection group: history of POTS, orthostatic symptoms, recent psychiatric admissions, substance use disorder, major trauma or surgery within last 5 years, severe untreated depression or anxiety
- For healthy controls: history of POTS, orthostatic symptoms, migraines, fibromyalgia, chronic fatigue, PTSD, functional gastrointestinal disorders, fainting, dysmenorrhea, chronic pain syndromes, recent psychiatric admissions, substance use disorder, major trauma or surgery within last 5 years, severe untreated depression or anxiety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
G
Gisela Chelimsky
CONTACT
B
Bhakti Dave
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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