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

Virginia Commonwealth University · with National Heart, Lung, and Blood Institute (NHLBI) · NCT06616363

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12–21 · Women only
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
120
US sites recruiting
1
Study start
May 29, 2024
Record last updated
September 29, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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. 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.

Being studied: 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

Conditions: POTS - Postural Orthostatic Tachycardia Syndrome

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Virginia Commonwealth University

    Richmond, VA 23298

    Site contact: Gisela Chelimsky · 804-827-3427 · Gisela.Chelimsky@vcuhealth.org

Study contacts (from the official record)

  • Gisela Chelimsky · 804-827-3427 · Gisela.Chelimsky@vcuhealth.org
  • Bhakti Dave · 804-827-3427 · Gisela.Chelimsky@vcuhealth.org
All healthy volunteers studies in Virginia →
Does a Periaqueductal Gray-vagus Nerve Interface Malfunction… (NCT06616363) | Bored Studies