Understanding how the brain communicates in young people with Postural Tachycardia Syndrome
Pediatric POTS: Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?
This study is testing how young people with Postural Tachycardia Syndrome understand visual information to see how their brain communicates differently compared to healthy peers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 12 Years to 21 Years |
| Sex | Female |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT05618054 on ClinicalTrials.gov |
What this trial studies
This study investigates how individuals aged 12-21 with Postural Tachycardia Syndrome (POTS) perceive and interpret visual information. By utilizing a looming task, researchers aim to explore the communication between different brain regions in these patients. The findings may provide insights into the natural history of POTS and its associated co-morbidities, potentially enhancing the understanding of this condition. The study includes age-matched healthy controls for comparative analysis.
Who should consider this trial
Good fit: Ideal candidates are females aged 12-21 who have been diagnosed with POTS and can communicate effectively.
Not a fit: Patients with chronic neurological disorders or significant unstable medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved diagnostic and therapeutic strategies for patients with POTS.
How similar studies have performed: While this approach is relatively novel, similar studies exploring brain function in POTS have shown promise in understanding the condition.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Gisela Chelimsky, M.D. — Virginia Commonwealth University
- Study coordinator: Gisela Chelimsky, M.D.
- Email: gisela.chelimsky@vcuhealth.org
- Phone: (804) 628-0145
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.