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Understanding POTS and Its Connections to Pain

This observational study is looking at Postural Orthostatic Tachycardia Syndrome (POTS) in young women aged 12 to 21. Researchers want to understand if a problem in a specific brain area (the periaqueductal gray region) might explain why POTS often comes with other conditions like migraines or fibromyalgia. You would complete questionnaires, provide lists of your medications and past health events, and use a phone app to record new life events. You would also wear an activity monitor and have periodic urine sodium checks. The study aims to see how your functional ability and pain coping strategies change over 24 months. To join, you need to have POTS symptoms and a specific heart rate increase during a tilt table test.

Study design
This is an observational study planning to enroll 120 young women with POTS. It does not involve new treatments but rather collects information about your health and experiences.
What's involved
You would complete questionnaires, provide medication lists and health history, use a phone app, wear an activity monitor, and have periodic urine sodium checks. This information will be collected over 24 months, with some in-person visits and some completed from home.
Compensation
Not stated in the trial record.
Follow-up
Your functional ability and pain coping will be measured for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06616363

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

Recruiting
Not specifiedAges 12–21Observational
Virginia Commonwealth University
~120 participants
Updated 2025-09-26 on ClinicalTrials.gov
What's tested:Questionnaires to be competedProvide list of medication and lifetime eventsUse phone App to record new life eventsWill wear an activity monitorPeriodic 24-hour urine sodium checkA fMRI scan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Functional Disability Inventory (FDI)
Measured over 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
+4 more outcomes measured

Conditions

POTS - Postural Orthostatic Tachycardia Syndrome

Explore related trials

Digestive System InfectionHealthyPostural Orthostatic Tachycardia SyndromeUpper Respiratory Tract Infection

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Gisela Chelimsky · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

Who to contact

Gisela Chelimsky
[email protected]
804-827-3427
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
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
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

What this trial measures

  • Functional Disability Inventory (FDI)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

    The total score determines the level of functional disability, in which higher numbers represent a higher level of disability. There are 15-items and a score of 0 indicates that there are no complaints present whereas 30 indicates that the patient is extremely disabled. The Functional Disability Inventory (FDI) is one of the most widely used measures of functional impairment among children and adolescents with chronic pain. It is expected that there will be higher threat sensitivity that correlates with POTS severity (FDI score) across the POTS cohort, and within subjects based on clinical evolution.

  • Pain Coping Questionnaire short formExperimental 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

    The Pain Coping Questionnaire (PCQ) is a 39-item self-report measure for evaluating pain coping in children and adolescents in both clinical and research settings. It consists of 8 subscales that can be categorized into 3 higher-order factors, including approach (composed of information seeking, problem-solving, and seeking social support subscales), problem-focused avoidance (composed of positive self-statements, behavioural distraction, and cognitive distraction subscales), and emotion-focused avoidance (composed of externalizing and internalizing/catastrophizing subscales). Higher scores indicate higher use of a particular coping strategy or style.

  • Pain Catastrophizing Scale (PCS-C)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

    The Pain Catastrophizing Scale for Children (PCS-C) is a 13-item self-report scale that measures how children think negatively about pain. The PCS-C asks respondents to rate how often they have pain-related thoughts and feelings on a scale of 0-4, with 0 meaning "not at all true" and 4 meaning "very true". The PCS-C is scored 1) Total score: The sum of all responses, ranging from 0-52, with higher scores indicating more catastrophic thinking 2) Subscale scores: The PCS-C assesses three dimensions of pain catastrophizing: rumination, magnification, and helplessness

  • Functional MRI (fMRI) scan while completing a complete a looming animacy threat task; participants judge the valence of images via button press as they perceive the image.Experimental cohort: Baseline, 3, 6, 12, 24 month in person visits. Control Cohort: Baseline, 3, 6, and 12 month in person visits.

    Functional MRI is a type of MRI scan that can show which areas of your brain are most active. Tracking and comparing that activity to what you were doing at the time can help "map" your brain activity. It's most often used for planning surgery or similar procedures in the brain. Functional MRI (fMRI) scan in this study will be completed while completing a looming animacy threat task; participants judge the valence of images via button press as they perceive the image.

  • Bedside Tilt testExperimental cohort: Baseline, 3, 6, 12, 24 month in person visits. Control Cohort: Baseline, 3, 6, and 12 month in person visits.

    A tilt table test, also known as a tilt test, is a procedure that helps determine the cause of fainting or near fainting spells. It involves lying on a table that's tilted to different positions while a medical professional monitors your heart rate, blood pressure, and oxygen levels.