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Search / Trial NCT05618054

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

Launched by VIRGINIA COMMONWEALTH UNIVERSITY · Nov 9, 2022

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how the brains of young women with Postural Tachycardia Syndrome (POTS) process information. POTS is a condition where a person's heart rate increases significantly when they stand up, which can lead to various symptoms like dizziness and fatigue. By studying how these individuals interpret what they see, researchers hope to gain insights into how different parts of the brain communicate with each other. This knowledge could help doctors better understand POTS and its related health issues.

To participate in this study, you must be a female between the ages of 12 and 21 who speaks English and has been diagnosed with POTS. The study is currently looking for participants, and you will be asked to share your experiences and thoughts during the trial. It's important to note that certain health conditions, like autoimmune disorders or chronic neurological issues, may exclude you from participating. If you join, you can expect a supportive environment where your insights will contribute to important research that may help others with similar conditions.

Gender

FEMALE

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

About Virginia Commonwealth University

Virginia Commonwealth University (VCU) is a prominent academic institution and research leader located in Richmond, Virginia. Renowned for its commitment to advancing healthcare through innovative research and education, VCU plays a pivotal role in clinical trials aimed at improving patient outcomes and understanding complex health issues. The university boasts a collaborative environment, leveraging its diverse faculty expertise and state-of-the-art facilities to conduct rigorous clinical research across various medical disciplines. VCU's dedication to ethical research practices and community engagement ensures that its clinical trials are designed to address critical health challenges while prioritizing participant safety and well-being.

Locations

Richmond, Virginia, United States

Patients applied

0 patients applied

Trial Officials

Gisela Chelimsky, M.D.

Principal Investigator

Virginia Commonwealth University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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