Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Nat hx With Its Numerous Co-morbidities?

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age12-21
SponsorVirginia Commonwealth University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Pregnant or breastfeeding

Cognitive defects that preclude answering questionnaires or following assessment directions

Other chronic diseases

Unstable medical conditions

Trial design

Treatments tested in this trial

  • Questionnaires to be competed
  • Provide list of medication and lifetime events
  • Use phone App to record new life events
  • Will wear an activity monitor
  • Periodic 24-hour urine sodium check
  • A fMRI scan
  • A bedside tilt test will be performed
  • IV placed to collect blood samples
  • Stool Sample

Treatment groups

120 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Virginia Commonwealth University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator