Postural Tachycardia SyndromeNCT05618054
Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?
A study testing Looming task in people with Postural Tachycardia Syndrome, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study is being conducted to see how people with Postural tachycardia syndrome (POTS) make sense of the things they see. The information may help doctors to learn more about how the different parts of people's brains communicate. 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
- Postural Tachycardia Syndrome
- What is being tested?
- Looming task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2023to Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Females 12-21 years old
- Able to communicate and provide consent/assent
- English speaking
- Diagnosed with POTS (POTS will be defined standardly as a symptomatic ≥ 40 bpm rise in heart rate without a drop in blood pressure and with symptoms of orthostatic intolerance clinically)
- Age-matched healthy control subjects: no POTS or other neurological disorders
Who cannot join
- Inflammatory arthritis, connective tissue or auto-immune disorder
- Any chronic neurological disorder besides POTS
- Evidence of unstable medical disorder, such as kidney (rising creatinine, or end-stage renal failure) or liver impairment (rising AST or ALT, or end-stage with coagulopathy), poorly controlled significant cardiovascular (CHF), respiratory, endocrine (diabetes - A1c > 9 - or untreated thyroid dysfunction) or uncontrolled psychiatric illness (such as untreated depression, psychosis, etc.)
- Neuropathy, central nervous system disorder (e.g., Cerebral palsy, developmental delay, seizure disorder, MS, stroke, etc.)
- Treatment with a drug or medical device within the previous 30 days that has not received regulatory approval
- Use of hormones (except insulin, thyroid replacement or oral contraceptives, which will be carefully documented)
Show all 13Show fewer
- Current substance or alcohol abuse
- Any major surgical intervention with general anesthesia in the last 60 days and minor procedure, such as tooth extraction, endoscopy, etc., with local or conscious sedation within 7 days
- Any on-going or pending medical, health or disability related litigation, or current pursuit of disability
- Any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which would clearly confound the interpretation of the study results (specific reason will be documented)
- Chronic use of narcotics for pain
- Claustrophobia or any metal hardware that may interfere with MRI
- Investigators and study staff
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Madison Maxwell, B.S. contact
United States1 site, 1 recruiting
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Pediatric POTS: Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?
This study is being conducted to see how people with Postural tachycardia syndrome (POTS) make sense of the things they see. The information may help doctors to learn more about how the different parts of people's brains communicate.
- Conditions
- Postural Tachycardia Syndrome
- Being tested
- Looming task
- 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.
Looming taskBehavioural
Participants will be asked to look at some pictures during an fMRI scan. Participants will press a button as soon as they see the image appear.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with POTS | Other | Not described Receives: Behavioral: Looming task |
| Adolescents without POTS | Other | Not described Receives: Behavioral: Looming task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periaqueductal gray region activation - looming task
Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region during the looming task
Measured: 90 minutes
Periaqueductal gray region activation - resting
Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region while at rest
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start6 Mar 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural Tachycardia SyndromeStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisela Chelimsky, M.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618054
- Sponsor's protocol ID
- HM20025242
- Status last verified
- Apr 2026
- First submitted
- 9 Nov 2022
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric POTS: Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?
- ClinicalTrials.gov ID
- NCT05618054
- Acronym / sponsor ID
- HM20025242
- Conditions
- Postural Tachycardia Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Nov 2022 (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.
This study is being conducted to see how people with Postural tachycardia syndrome (POTS) make sense of the things they see. The information may help doctors to learn more about how the different parts of people's brains communicate.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents with POTS | Other | Behavioral: Looming task |
| Adolescents without POTS | Other | Behavioral: Looming task |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Females 12-21 years old
- Able to communicate and provide consent/assent
- English speaking
- Diagnosed with POTS (POTS will be defined standardly as a symptomatic ≥ 40 bpm rise in heart rate without a drop in blood pressure and with symptoms of orthostatic intolerance clinically)
- Age-matched healthy control subjects: no POTS or other neurological disorders
Key exclusion criteria (13 listed)
- Inflammatory arthritis, connective tissue or auto-immune disorder
- Any chronic neurological disorder besides POTS
- Evidence of unstable medical disorder, such as kidney (rising creatinine, or end-stage renal failure) or liver impairment (rising AST or ALT, or end-stage with coagulopathy), poorly controlled significant cardiovascular (CHF), respiratory, endocrine (diabetes - A1c > 9 - or untreated thyroid dysfunction) or uncontrolled psychiatric illness (such as untreated depression, psychosis, etc.)
- Neuropathy, central nervous system disorder (e.g., Cerebral palsy, developmental delay, seizure disorder, MS, stroke, etc.)
- Treatment with a drug or medical device within the previous 30 days that has not received regulatory approval
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 |
|---|---|---|
| Looming taskParticipants will be asked to look at some pictures during an fMRI scan. Participants will press a button as soon as they see the image appear. | Behavioural | Adolescents with POTS, Adolescents without POTS |
Primary outcome
Periaqueductal gray region activation - looming task
Time frame: 90 minutes
Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region during the looming task
Periaqueductal gray region activation - resting
Time frame: 90 minutes
Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region while at rest
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 21 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Madison Maxwell, B.S. contact
Gisela Chelimsky, M.D. 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?
A study testing Looming task in people with Postural 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 5 inclusion and 13 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 21 Apr 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, M.D. ((804) 628-0145, gisela.chelimsky@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periaqueductal gray region activation - looming task (time frame: 90 minutes). The study lists 2 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 21 Apr 2026.