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Search / Trial NCT05618067

The Impact of Improved Vagal Function on Periaqueductal Gray Connectivity

Launched by VIRGINIA COMMONWEALTH UNIVERSITY · Nov 9, 2022

Trial Information

Current as of July 24, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring whether breathing exercise training can help improve symptoms for people with Postural Tachycardia Syndrome (POTS), a condition that affects how the body manages blood flow and heart rate when standing up. The study aims to understand better how different parts of the brain work together in individuals with this condition. It is not open for participants yet, but when it is, it will involve adults aged 18 to 50 who have been diagnosed with POTS or related issues and can read and speak English.

Eligible participants will need to have an upcoming appointment at the VCU Comprehensive Autonomics Center. They should not have certain other medical conditions, like chronic neurological disorders or significant uncontrolled health issues, as these could affect their ability to participate safely. If you join the study, you can expect to learn and practice breathing exercises, and researchers will monitor how these exercises could potentially improve your symptoms. This trial could provide valuable insights into new treatment approaches for POTS.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age 18-50 years
  • Diagnosis of POTS, orthostatic intolerance (with or without syncope), syncope, or near-syncope
  • Can speak and read in English
  • Upcoming new patient VCU Comprehensive Autonomics Center clinic visit scheduled at least 1 week in the future
  • Exclusion Criteria:
  • Inflammatory arthritis, connective tissue or auto-immune disorder
  • Any chronic neurological disorder besides POTS, orthostatic intolerance (with or without syncope), syncope, or near-syncope
  • Patients who have already had a new patient clinic visit where they were exposed to breathing exercise education
  • 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

Thomas Chelimsky, M.D.

Principal Investigator

Virginia Commonwealth University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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