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

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT06616363
Status
Recruiting
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Conditions

  • POTS - Postural Orthostatic Tachycardia Syndrome

Eligibility Criteria

Sex
FEMALE
Age
12 Years - 21 Years
Healthy Volunteers
Accepted

Interventions

  • Questionnaires to be competed — BEHAVIORAL
    * 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)
  • Provide list of medication and lifetime events — BEHAVIORAL
    Participants will provide a list of all medications taken at each visit time, lifetime history of infections, traumas, and other significant life events.
  • Use phone App to record new life events — BEHAVIORAL
    Subjects will also record new life events, minor traumas, entrance into a flare and menses in Ilumivu's EMA (Ecological Momentary Assessment) phone App
  • Will wear an activity monitor — DEVICE
    Participants will have an activity monitor loaned for the duration of the study to track their physical activity.
  • Periodic 24-hour urine sodium check — OTHER
    POTS patients will have a periodic 24-hour urine sodium check to determine compliance to intake of salt.
  • A fMRI scan — DIAGNOSTIC_TEST
    • 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 — DIAGNOSTIC_TEST
    A bedside tilt test will be performed where blood pressure will be recorded supine and upright positions to confirm/exclude POTS.
  • IV placed to collect blood samples — OTHER
    • 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.
  • Stool Sample — OTHER
    • 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

Study Details

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.

Key Dates

Start date
May 29, 2024
Status verified
Sep 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: 60 POTS Postural Tachycardia Syndrome (POTS)
    POTS patients will be current patients of the study practitioners within the autonomic, cardiology PM\&R clinics and autonomic laboratory. This cohort may receive a codified treatment plan within the following 7 treatment categories which are also standard of care procedures based on clinical recommendations: (1) salt, fluid and diet management; (2) exercise program with or without PT; (3) cognitive behavioral therapy or other counseling; (4) vagal stimulation forms like yoga, breathing exercises, relaxation, microauricular stimulation; (5) pharmacotherapy for pressure maintenance; (6) medications for pain and headache; (7) medications for the gastrointestinal issues.
  • Arm: 40 Post-Infection cohort
    Post-Infection participants will be identified through Best Practice Alerts through EPIC, and referrals from hospitalist and gastroenterology inpatient services. Post-Infection cohorts will be approached up to 6 weeks after they are released from the hospital, to ensure they are healthy enough to participate.
  • Arm: 20 healthy controls
    Healthy control participants will be recruited from local communities using flyers, social media and using EPIC Best Practice Alerts.

Primary Outcome Measure

Functional Disability Inventory (FDI) [ Time Frame: Experimental Cohort: Baseline and monthly for 24 months (3, 6, 12, 24 in-person study visits), the other months will be completed from home. The control cohort: months 0-12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298
Gisela Chelimsky
[email protected]
804-827-3427
Bhakti Dave,
[email protected]
804-828-7802
Gisela Chelimsky (PRINCIPAL_INVESTIGATOR)

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