Exploring the role of the brain in Postural Orthostatic Tachycardia Syndrome
(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?
This study is trying to see how the brain might be involved in Postural Orthostatic Tachycardia Syndrome (POTS) and how it affects people's symptoms and other health issues over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 12 Years to 21 Years |
| Sex | Female |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT06616363 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the potential central nervous system involvement in Postural Orthostatic Tachycardia Syndrome (POTS), a condition characterized by significant heart rate increases upon standing. It aims to gather natural history data and explore the relationship between POTS and its comorbidities through questionnaires, activity monitoring, and urine sodium checks. The study focuses on understanding how dysfunction in the periaqueductal gray region of the brain may contribute to the symptoms and associated conditions of POTS. Participants will be monitored over time to assess symptom changes and the impact of various life events.
Who should consider this trial
Good fit: Ideal candidates include adolescents with symptomatic POTS, characterized by a significant heart rate increase upon standing and clinical symptoms of orthostatic intolerance.
Not a fit: Patients who are pregnant, have cognitive defects, or other chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of POTS and improve treatment strategies for patients suffering from this debilitating condition.
How similar studies have performed: While there have been studies on POTS, this approach focusing on central nervous system mechanisms is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Gisela Chelimsky — Virginia Commonwealth University
- Study coordinator: Gisela Chelimsky
- Email: Gisela.Chelimsky@vcuhealth.org
- Phone: 804-827-3427
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.