Recruiting

Observational Study

Sponsor:

Virginia Commonwealth University

Code:

NCT05618054

Conditions

Postural Tachycardia Syndrome

Eligibility Criteria

Sex: Female

Age: 12 - 21

Healthy Volunteers: Accepted

Interventions

Looming task

Study Details

Brief 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.

Conditions

Postural Tachycardia Syndrome

Study ID

NCT05618054

Start date

Mar 6, 2023

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 12 - 21

Healthy Volunteers: Accepted

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:

  • 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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Adolescents with POTS

other: Adolescents without POTS

Interventions

Looming 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.

Primary outcome measure

  • Periaqueductal gray region activation - looming task [ Time Frame: 90 minutes ]
  • Periaqueductal gray region activation - resting [ Time Frame: 90 minutes ]

Central Contacts and Locations

Central contacts

Gisela Chelimsky, M.D.

(804) 628-0145gisela.chelimsky@vcuhealth.org

Madison Maxwell, B.S.

madison.maxwell@vcuhealth.org

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-04-21.