The Impact of Improved Vagal Function on Periaqueductal Gray Connectivity

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorVirginia Commonwealth University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: TrainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
90 minutes
2

Change in PAG activation - resting

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

Time frame
90 minutes
3

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

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

Secondary outcomes

1

Change in Fatigue Severity Scale (FSS) score from baseline

The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue by asking participants to answer 9 statements that rate the severity of their fatigue symptoms in the past week by selecting their answer on a 1-7 point Likert scale. Sum scores range from 9-36. A low value (e.g., 1) indicates strong disagreement with the statement (lower symptom severity), whereas a high value (e.g., 7) indicates strong agreement (higher symptom severity).

Time frame
Assessed at baseline, week 3, and week 6 (final visit).
2

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

The Generalized Anxiety Disorder Scale (GAD-2) is a method of evaluating anxiety symptoms by asking participants to answer 2 statements that rate the severity of their anxiety symptoms in the past 2 weeks by selecting their answer a 0-3 point Likert scale (0- not at all, 1- several days, 2 - more than half the days, 3 - nearly every day). Sum scores range from 0-6. A low value (e.g., 0) indicates no or less severe anxiety symptoms, whereas a high value (e.g. 3), indicates more severe anxiety symptoms.

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

Differences in Adverse Childhood Experiences (ACE) scores between participants

The Adverse Childhood Experiences (ACE) questionnaire is a method of evaluating childhood adversities such as emotional, physical, and sexual abuse/neglect by asking participants to answer 10 statements that describe events that happened during the first 18 years of their life. Participants indicate if this event occurred by selecting a Yes or No answer. Sum scores range from 0-10. Less "Yes" responses indicate less ACE occurrences, and more "Yes" responses indicate more ACE occurrences.

Time frame
Assessed at baseline.
4

Change in Pain Catastrophizing Scale (PCS) score from baseline

The Pain Catastrophizing Scale (PCS) is a method of evaluating pain catastrophizing, measuring pain-related cognitions and the dimensions of helplessness, rumination and magnification by asking participants to answer 13 items that describe different thoughts and feelings that may be associated with their pain. Participants rate how strong their feelings are about pain on a 5 point scale (0- Not at all, 1- To a slight degree, 2- To a moderate degree, 3- To a great degree, 4- All the time). Sum scores range from 0-52. Higher scores indicate higher levels of pain catastrophizing. A total PCS score of 30 represents a clinically relevant level of catastrophizing.

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

Other outcomes

Sponsors and contacts

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