The Impact of Improved Vagal Function on Periaqueductal Gray Connectivity

NCT05618067 | Not Yet Recruiting

• 1 other identifier: HM20025315
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being to see if participating in breathing exercise training and practicing this training will help with Postural tachycardia syndrome (POTS). The information may help doctors to learn more about how the different parts of people's brains communicate.

Conditions

Postural Tachycardia Syndrome

Outcome Measures

Primary Outcomes (3)

• Change in periaqueductal gray region (PAG) activation - looming task

  Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the PAG region during the looming task

  90 minutes

• Change in PAG activation - resting

  Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the PAG region while at rest

  90 minutes

• Change in Heart Rate Variability (HRV)

  HRV will be measured using an ear clip and/or wristband and results will be recorded automatically in the app

  Assessed for 2 days each week for the duration of the study (6 weeks).

Secondary Outcomes (10)

• Change in Fatigue Severity Scale (FSS) score from baseline

  Assessed at baseline, week 3, and week 6 (final visit).

• Change in Generalized Anxiety Disorder Scale (GAD-2) score from baseline

  Assessed at baseline, week 3, and week 6 (final visit).

• Differences in Adverse Childhood Experiences (ACE) scores between participants

  Assessed at baseline.

• Change in Pain Catastrophizing Scale (PCS) score from baseline

  Assessed at baseline, week 3, and week 6 (final visit).

• Change in Patient Health Questionnaire (PHQ-9) score from baseline

  Assessed at baseline, week 3, and week 6 (final visit).

Study Arms (1)

Training

EXPERIMENTAL

Behavioral: breathing exercise training

Interventions

breathing exercise training BEHAVIORAL

Participants will engage in weekly breathing exercises. They will be trained once a week for 4 weeks, and will use an app called Inner Balance and an device called Firstbeat Bodyguard 3 to track data about their hearts while practicing the exercises at home for 10 minutes a day, twice a day, once before bedtime.

Training

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virnigia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Thomas Chelimsky, M.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Chelimsky, M.D.

CONTACT

(804)-628-0145; thomas.chelimsky@vcuhealth.org

Madison Maxwell, B.S.

CONTACT

maxwellme@vcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 16, 2022
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)