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?
Virginia Commonwealth University
120 participants
May 29, 2024
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria5
- POTS sample
- 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
- acute upper respiratory or gastrointestinal infection that required admission to the acute care units but not requiring an ICU stay
- Apparently healthy with no known chronic illnesses
Exclusion Criteria30
- 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
- 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
- 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
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Interventions
* The Pain Coping Questionnaire short form * Functional Disability Inventory (FDI), the primary clinical outcome measure. * COMPASS-31 and orthostatic hypotension modified for POTS. * The Pain Response Inventory (PRI)PROMIS Depression * GAD-7 for anxiety * Varni/Thompson Pediatric Pain Questionnaire * Child and Parent Reports of Post-Traumatic Symptoms (CROPS/PROPS) * Pain Catastrophizing Scale (PCS-C) * Detailed account of natural history and evolution of POTS and COPCs through MEDYSA (facilitates the assessment of specific syndromic diagnoses based on published criteria, rather than organ-based classification of symptoms)
Participants will provide a list of all medications taken at each visit time, lifetime history of infections, traumas, and other significant life events.
Subjects will also record new life events, minor traumas, entrance into a flare and menses in Ilumivu's EMA (Ecological Momentary Assessment) phone App
Participants will have an activity monitor loaned for the duration of the study to track their physical activity.
POTS patients will have a periodic 24-hour urine sodium check to determine compliance to intake of salt.
• Participants will complete a fMRI scan without contrast and complete a looming animacy threat task; participants judge the valence of images via button press as they perceive the image.
A bedside tilt test will be performed where blood pressure will be recorded supine and upright positions to confirm/exclude POTS.
• An IV will be place for collection of 4 blood samples, about 12 mL of blood. For each position (lying and standing) the study team will draw 2 tubes each times with 3 mL of blood, for a total of 4 lab tubes (12 mL). Physical exams to assess the 18-tender points described by the American College of Rheumatology for the diagnosis of fibromyalgia and hypermobility/Ehlers-Danlos Syndrome (EDS) exam will be performed in all subjects.
• Participants will provide a stool biospecimen sample at each in-person visit. Stool will be collected in a hat and sample will be swabbed with the swab placed directly into PrimeStore collection tube and the remainder of the sample discarded
Locations(1)
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NCT06616363