Clinical trial NCT05618067: The Impact of Improved Vagal Function on Periaqueductal Gray Connectivity
Official title: The Impact of Improved Vagal Function on Periaqueductal Gray Connectivity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postural Tachycardia Syndrome
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in periaqueductal gray region (PAG) activation - looming task
timeFrame: 90 minutes
measure: Change in PAG activation - resting
timeFrame: 90 minutes
measure: Change in Heart Rate Variability (HRV)
timeFrame: Assessed for 2 days each week for the duration of the study (6 weeks).
Secondary outcomes:
measure: Change in Fatigue Severity Scale (FSS) score from baseline
timeFrame: Assessed at baseline, week 3, and week 6 (final visit).
measure: Change in Generalized Anxiety Disorder Scale (GAD-2) score from baseline
timeFrame: Assessed at baseline, week 3, and week 6 (final visit).
measure: Differences in Adverse Childhood Experiences (ACE) scores between participants
timeFrame: Assessed at baseline.
measure: Change in Pain Catastrophizing Scale (PCS) score from baseline
timeFrame: Assessed at baseline, week 3, and week 6 (final visit).
measure: Change in Patient Health Questionnaire (PHQ-9) score from baseline
timeFrame: Assessed at baseline, week 3, and week 6 (final visit).
measure: Change in Pittsburgh Sleep Quality Index (PSQI) from baseline
timeFrame: Assessed at baseline, week 3, and week 6 (final visit).
measure: Change in PROMIS Physical Function (PROMIS 8b) from baseline
timeFrame: Assessed at baseline, week 3, and week 6 (final visit).
measure: Change in the Perceived Stress Scale (PSS) from baseline
timeFrame: Assessed at baseline, week 3, and week 6 (final visit).
measure: Change in the PTSD Checklist (PCL-5) from baseline
timeFrame: Assessed at baseline, week 3, and week 6 (final visit).
measure: Change in the Pain, Enjoyment of Life, and General Activity (PEG-3) from baseline
timeFrame: Assessed at baseline, week 3, and week 6 (final visit).
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virnigia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Thomas Chelimsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References: