RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

(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?

Quick Facts

Study Start:2024-05-29
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06616363

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 21 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * symptomatic ≥ 40 bpm rise in heart rate in the first 10 min of a tilt table study without a drop in blood pressure
  2. * Clinical symptoms of orthostatic intolerance
  1. * Pregnant or breastfeeding
  2. * Cognitive defects that preclude answering questionnaires or following assessment directions
  3. * Other chronic diseases
  4. * Unstable medical conditions
  5. * Use of narcotics
  6. * Limited English proficiency
  7. * Investigator discretion that participant would not be suitable to participate
  8. * A phone older than 5 years old or unable to support EMA software

Contacts and Locations

Study Contact

Gisela Chelimsky
CONTACT
804-827-3427
Gisela.Chelimsky@vcuhealth.org
Bhakti Dave
CONTACT
804-827-3427
Gisela.Chelimsky@vcuhealth.org

Principal Investigator

Gisela Chelimsky
PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University

Study Locations (Sites)

Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

  • Gisela Chelimsky, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-29
Study Completion Date2028-07

Study Record Updates

Study Start Date2024-05-29
Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

  • PAG activation
  • Cardiovagal Modulation

Additional Relevant MeSH Terms

  • POTS - Postural Orthostatic Tachycardia Syndrome