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RecruitingNCT05618054Updated Apr 21, 2026

Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?

An interventional study of Looming task in Postural Tachycardia Syndrome, sponsored by Virginia Commonwealth University. Recruiting at 1 site in United States. Open to female participants aged 12 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Mar 2023; still recruiting 3 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
12 Years to 21 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Postural Tachycardia Syndrome
03

In context

Postural Orthostatic Tachycardia Syndrome

131 studies on the registry are indexed under Postural Orthostatic Tachycardia Syndrome; 44 are open to participants now.

This study's planned enrollment of 36 is close to the median of 36 across 98 interventional studies indexed under Postural Orthostatic Tachycardia Syndrome.

Browse Postural Orthostatic Tachycardia Syndrome studies →

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 21 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Other
    Adolescents with POTS

    Behavioral: Looming task

  • Other
    Adolescents without POTS

    Behavioral: Looming task

Interventions

  • BehavioralLooming task

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 90 minutes

  2. Periaqueductal gray region activation - resting

    Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region while at rest

    Time frame: 90 minutes

07

Study locations

1 of 1 sites recruiting
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05618054
Lead sponsor
Virginia Commonwealth University
Responsible party
Sponsor
First posted
Nov 16, 2022
Start date
Mar 6, 2023
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 21, 2026

Study contacts

Gisela Chelimsky, M.D.
Contact
gisela.chelimsky@vcuhealth.org
(804) 628-0145
Madison Maxwell, B.S.
Contact
madison.maxwell@vcuhealth.org
Gisela Chelimsky, M.D.
principal investigator · Virginia Commonwealth University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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