POTS - Postural Orthostatic Tachycardia SyndromeNCT06616363
Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Nat hx With Its Numerous Co-morbidities?
An observational study of POTS - Postural Orthostatic Tachycardia Syndrome, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- POTS - Postural Orthostatic Tachycardia Syndrome
- What is being tested?
- Questionnaires to be competed, Provide list of medication and lifetime events and Use phone App to record new life events
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2024to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: The study aims to recruit only females aged 12-21. Females will be targeted specifically since POTS is more common in females than males and avoids creation of a subgroup too small to analyze.
Who may be able to join
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Gisela Chelimsky, 804-827-3427, Gisela.Chelimsky@vcuhealth.org
Bhakti Dave,, 804-828-7802, bhakti.dave@vcuhealth.org
About this study
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?
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.
Read the detailed description
The current definition of POTS highlights the peripheral mechanistic emphasis of 30 years of studies exploring cardio- and cerebro-vascular, immunologic, mast cell activation, connective tissue and other physiologic mechanisms. The classification of POTS itself also assumes a peripheral etiology, typically including neuropathic, hyperadrenergic, hypovolemic and sometimes immune POTS. However, a central nervous system (CNS) etiology might better account for what is knowns about POTS currently: (1) POTS often follows an infection, physical or psychological trauma. (2) POTS occurs most often in post-menarche adolescent girls volume redistribution differs across subjects (4) exercise, cognitive behavioral therapy provide best long-term outcomes (5) co-morbid disorders, typically overlapping pain conditions such as migraine headache, fibromyalgia, and most functional gastrointestinal disorders (FGID), often dominate the clinical picture. COPCs are typically considered to reflect a CNS etiology.
Because it coordinates the autonomic, motor and pain responses to an acute threat, the midbrain periaqueductal gray region (PAG) is an attractive candidate whose dysfunction could potentially explain all major features of POTS, including the frequent antecedent emotional or physical threat, the POTS core autonomic changes, and the co-morbid pain disorders. The PAG interprets threats as escapable or inescapable, specifically activating a different column for each response type.
- Being tested
- Questionnaires to be competed, Provide list of medication and lifetime events, Use phone App to record new life events, Will wear an activity monitor, Periodic 24-hour urine sodium check
- Keywords
- PAG activation, Cardiovagal Modulation
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires to be competedBehavioural
- 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 eventsBehavioural
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 eventsBehavioural
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 monitorDevice
Participants will have an activity monitor loaned for the duration of the study to track their physical activity.
Periodic 24-hour urine sodium checkOther
POTS patients will have a periodic 24-hour urine sodium check to determine compliance to intake of salt.
A fMRI scanDiagnostic 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 performedDiagnostic 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 samplesOther
- 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 SampleOther
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Questionnaires to be competed; Behavioral: Provide list of medication and lifetime events; Behavioral: Use phone App to record new life events; Device: Will wear an activity monitor; Other: Periodic 24-hour urine sodium check; Diagnostic Test: A fMRI scan; Diagnostic Test: A bedside tilt test will be performed; Other: IV placed to collect blood samples; Other: Stool Sample | |
| 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. Receives: Behavioral: Questionnaires to be competed; Behavioral: Provide list of medication and lifetime events; Behavioral: Use phone App to record new life events; Device: Will wear an activity monitor; Diagnostic Test: A fMRI scan; Diagnostic Test: A bedside tilt test will be performed; Other: IV placed to collect blood samples; Other: Stool Sample | |
| 20 healthy controls | Healthy control participants will be recruited from local communities using flyers, social media and using EPIC Best Practice Alerts. Receives: Behavioral: Questionnaires to be competed; Behavioral: Provide list of medication and lifetime events; Behavioral: Use phone App to record new life events; Device: Will wear an activity monitor; Diagnostic Test: A fMRI scan; Diagnostic Test: A bedside tilt test will be performed; Other: IV placed to collect blood samples; Other: Stool Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Disability Inventory (FDI)
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.
Measured: 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
Pain Coping Questionnaire short form
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.
Measured: 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
Pain Catastrophizing Scale (PCS-C)
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
Measured: 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
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.
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.
Measured: Experimental cohort: Baseline, 3, 6, 12, 24 month in person visits. Control Cohort: Baseline, 3, 6, and 12 month in person visits.
Bedside Tilt test
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.
Measured: Experimental cohort: Baseline, 3, 6, 12, 24 month in person visits. Control Cohort: Baseline, 3, 6, and 12 month in person visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start29 May 2024
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for POTS - Postural Orthostatic Tachycardia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Gisela Chelimsky, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616363
- Sponsor's protocol ID
- HM20029682
- Other IDs
- 1R01HL163577
- Status last verified
- Sep 2026
- First submitted
- 23 Jul 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT06616363
- Acronym / sponsor ID
- HM20029682
- Keywords
- PAG activation, Cardiovagal Modulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 29 May 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The current definition of POTS highlights the peripheral mechanistic emphasis of 30 years of studies exploring cardio- and cerebro-vascular, immunologic, mast cell activation, connective tissue and other physiologic mechanisms. The classification of POTS itself also assumes a peripheral etiology, typically including neuropathic, hyperadrenergic, hypovolemic and sometimes immune POTS. However, a central nervous system (CNS) etiology might better account for what is knowns about POTS currently: (1) POTS often follows an infection, physical or psychological trauma. (2) POTS occurs most often in post-menarche adolescent girls volume redistribution differs across subjects (4) exercise, cognitive behavioral therapy provide best long-term outcomes (5) co-morbid disorders, typically overlapping pain conditions such as migraine headache, fibromyalgia, and most functional gastrointestinal disorders (FGID), often dominate the clinical picture. COPCs are typically considered to reflect a CNS etiology.
Because it coordinates the autonomic, motor and pain responses to an acute threat, the midbrain periaqueductal gray region (PAG) is an attractive candidate whose dysfunction could potentially explain all major features of POTS, including the frequent antecedent emotional or physical threat, the POTS core autonomic changes, and the co-morbid pain disorders. The PAG interprets threats as escapable or inescapable, specifically activating a different column for each response type.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 60 POTS Postural Tachycardia Syndrome (POTS) | – | Behavioral: Questionnaires to be competed, Behavioral: Provide list of medication and lifetime events, Behavioral: Use phone App to record new life events, Device: Will wear an activity monitor, Other: Periodic 24-hour urine sodium check, Diagnostic Test: A fMRI scan, Diagnostic Test: A bedside tilt test will be performed, Other: IV placed to collect blood samples, Other: Stool SamplePOTS 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. |
| 40 Post-Infection cohort | – | Behavioral: Questionnaires to be competed, Behavioral: Provide list of medication and lifetime events, Behavioral: Use phone App to record new life events, Device: Will wear an activity monitor, Diagnostic Test: A fMRI scan, Diagnostic Test: A bedside tilt test will be performed, Other: IV placed to collect blood samples, Other: Stool SamplePost-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. |
| 20 healthy controls | – | Behavioral: Questionnaires to be competed, Behavioral: Provide list of medication and lifetime events, Behavioral: Use phone App to record new life events, Device: Will wear an activity monitor, Diagnostic Test: A fMRI scan, Diagnostic Test: A bedside tilt test will be performed, Other: IV placed to collect blood samples, Other: Stool SampleHealthy control participants will be recruited from local communities using flyers, social media and using EPIC Best Practice Alerts. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study aims to recruit only females aged 12-21. Females will be targeted specifically since POTS is more common in females than males and avoids creation of a subgroup too small to analyze.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (30 listed)
- Pregnant or breastfeeding
- Cognitive defects that preclude answering questionnaires or following assessment directions
- Other chronic diseases
- Unstable medical conditions
- Use of narcotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires to be competed* 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) | Behavioural | 20 healthy controls, 40 Post-Infection cohort, 60 POTS Postural Tachycardia Syndrome (POTS) |
| Provide list of medication and lifetime eventsParticipants will provide a list of all medications taken at each visit time, lifetime history of infections, traumas, and other significant life events. | Behavioural | 20 healthy controls, 40 Post-Infection cohort, 60 POTS Postural Tachycardia Syndrome (POTS) |
| Use phone App to record new life eventsSubjects will also record new life events, minor traumas, entrance into a flare and menses in Ilumivu's EMA (Ecological Momentary Assessment) phone App | Behavioural | 20 healthy controls, 40 Post-Infection cohort, 60 POTS Postural Tachycardia Syndrome (POTS) |
| Will wear an activity monitorParticipants will have an activity monitor loaned for the duration of the study to track their physical activity. | Device | 20 healthy controls, 40 Post-Infection cohort, 60 POTS Postural Tachycardia Syndrome (POTS) |
| Periodic 24-hour urine sodium checkPOTS patients will have a periodic 24-hour urine sodium check to determine compliance to intake of salt. | Other | 60 POTS Postural Tachycardia Syndrome (POTS) |
| A fMRI scan• 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. | Diagnostic test | 20 healthy controls, 40 Post-Infection cohort, 60 POTS Postural Tachycardia Syndrome (POTS) |
| A bedside tilt test will be performedA bedside tilt test will be performed where blood pressure will be recorded supine and upright positions to confirm/exclude POTS. | Diagnostic test | 20 healthy controls, 40 Post-Infection cohort, 60 POTS Postural Tachycardia Syndrome (POTS) |
| IV placed to collect blood samples• 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. | Other | 20 healthy controls, 40 Post-Infection cohort, 60 POTS Postural Tachycardia Syndrome (POTS) |
| Stool Sample• 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 | Other | 20 healthy controls, 40 Post-Infection cohort, 60 POTS Postural Tachycardia Syndrome (POTS) |
Primary outcome
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
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 form
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
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)
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
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.
Time frame: 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 test
Time frame: Experimental 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gisela Chelimsky principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of POTS - Postural Orthostatic Tachycardia Syndrome, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gisela Chelimsky (804-827-3427, Gisela.Chelimsky@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.