NCT05618054 Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?
| NCT ID | NCT05618054 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Virginia Commonwealth University |
| Condition | Postural Tachycardia Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-03-06 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2023-03-06 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Gisela Chelimsky, M.D.
PRINCIPAL INVESTIGATOR
Virginia Commonwealth University
Frequently Asked Questions
Who can join the NCT05618054 clinical trial?
This trial is open to female participants only, aged 12 Years or older, up to 21 Years, studying Postural Tachycardia Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05618054 currently recruiting?
Yes, NCT05618054 is actively recruiting participants. Contact the research team at gisela.chelimsky@vcuhealth.org for enrollment information.
Where is the NCT05618054 trial being conducted?
This trial is being conducted at Richmond, United States.
Who is sponsoring the NCT05618054 clinical trial?
NCT05618054 is sponsored by Virginia Commonwealth University. The principal investigator is Gisela Chelimsky, M.D. at Virginia Commonwealth University. The trial plans to enroll 36 participants.