The Impact of Improved Vagal Function on Periaqueductal Gray Connectivity
Primary Purpose
Postural Tachycardia Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
breathing exercise training
Sponsored by
About this trial
This is an interventional supportive care trial for Postural Tachycardia Syndrome
Eligibility Criteria
Inclusion Criteria: Age 18-50 years Diagnosis of POTS Can speak and read in English 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
Sites / Locations
- Virnigia Commonwealth University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Training
Arm Description
Outcomes
Primary Outcome Measures
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
Change in PAG activation - resting
Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the PAG region while at rest
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
Secondary Outcome Measures
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).
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.
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.
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.
Change in Patient Health Questionnaire (PHQ-9) score from baseline
The Patient Health Questionnaire (PHQ-9) objectifies and assesses degree of depression severity via questionnaire by asking participants to answer 9 items that rate the severity of depression symptoms over the past 2 weeks on 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 0-36. A low value (e.g., 0) indicates no or less severe depression symptoms, whereas a high value (e.g. 3), indicates more severe depression symptoms.
Change in Pittsburgh Sleep Quality Index (PSQI) from baseline
The Pittsburgh Sleep Quality Index (PSQI) measures quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the past month. Participants are asked to answer 19 items. 5 items are free response and ask questions about sleep duration. The remaining 14 items are answered on a 0-3 point Likert scale (0 - not during the past month, 1- less than once a week, 2- once or twice a week, 3- three or more times a week) that describe the frequency of the listed events. A global score is calculated from the sum of 7 component scores and ranges from 0-21, with lower scores indicating lower sleep dysfunction and higher scores indicating higher sleep dysfunction.
Change in PROMIS Physical Function (PROMIS 8b) from baseline
The PROMIS Physical Function (PROMIS 8b) instrument measures self-reported capability of physical activities by asking participants to respond to 8 items on a 5-point Likert scale. The scale for the first 4 items is as follows: 5- Without any difficulty, 4- With a little difficulty, 3- With some difficulty, 2- With much difficulty, 1- Unable to do. The scale for the last 4 items is as follows: 5- Not at all, 4- Very little, 3- Somewhat, 2- Quite a lot, 1- Cannot do. Raw sum scores range from 8-40 and are converted into a T-score ranging from 20.3 to 60.1, with higher scores indicating better physical function and lower scores indicating poorer physical function.
Change in the Perceived Stress Scale (PSS) from baseline
The Perceived Stress Scale (PSS) measures how different situations affect feelings and perceived stress. Participants are asked to answer 10 items that describe the frequency of their feelings and thoughts described in each item during the last month on a 0-4 point Likert scale (0 - never, 1- almost never, 2- sometimes, 3- fairly often, 4- very often). Sum scores range from 0-40, with lower scores indicating less perceived stress levels and higher scores indicating higher perceived stress levels.
Change in the PTSD Checklist (PCL-5) from baseline
The PCL-5 assesses the 20 DSM-5 symptoms of PTSD. Participants are asked to answer 5 free response questions about the worst & more stressful event to which they were exposed, then 20 items about the event on a 0-4 point Likert scale (0- not at all, 1- a little bit, 2- moderately, 3- quite a bit, 4- extremely). Sum scores of the 20 Likert-format items range from 0-80, with lower scores indicating less severe PTSD symptoms and higher scores indicating more severe PTSD symptoms.
Change in the Pain, Enjoyment of Life, and General Activity (PEG-3) from baseline
The Pain, Enjoyment of Life, and General Activity (PEG-3) scale assesses pain levels and interference with enjoyment of life and activity. Participants are asked to answer 3 items on a 0-10 point Likert scale. For item 1, the scale is as follows: 0- no pain, 10- pain as bad as you can imagine. For items 2-3, the scale is as follows: 0- does not interfere, 10- completely interferes. Sum scores range from 0-30, with lower scores indicating less pain and/or interference and higher scores indicating more pain and/or interference.
Full Information
NCT ID
NCT05618067
First Posted
November 9, 2022
Last Updated
September 27, 2023
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT05618067
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Tachycardia Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
breathing exercise training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in periaqueductal gray region (PAG) activation - looming task
Description
Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the PAG region during the looming task
Time Frame
90 minutes
Title
Change in PAG activation - resting
Description
Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the PAG region while at rest
Time Frame
90 minutes
Title
Change in Heart Rate Variability (HRV)
Description
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 Outcome Measure Information:
Title
Change in Fatigue Severity Scale (FSS) score from baseline
Description
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).
Title
Change in Generalized Anxiety Disorder Scale (GAD-2) score from baseline
Description
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).
Title
Differences in Adverse Childhood Experiences (ACE) scores between participants
Description
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.
Title
Change in Pain Catastrophizing Scale (PCS) score from baseline
Description
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).
Title
Change in Patient Health Questionnaire (PHQ-9) score from baseline
Description
The Patient Health Questionnaire (PHQ-9) objectifies and assesses degree of depression severity via questionnaire by asking participants to answer 9 items that rate the severity of depression symptoms over the past 2 weeks on 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 0-36. A low value (e.g., 0) indicates no or less severe depression symptoms, whereas a high value (e.g. 3), indicates more severe depression symptoms.
Time Frame
Assessed at baseline, week 3, and week 6 (final visit).
Title
Change in Pittsburgh Sleep Quality Index (PSQI) from baseline
Description
The Pittsburgh Sleep Quality Index (PSQI) measures quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the past month. Participants are asked to answer 19 items. 5 items are free response and ask questions about sleep duration. The remaining 14 items are answered on a 0-3 point Likert scale (0 - not during the past month, 1- less than once a week, 2- once or twice a week, 3- three or more times a week) that describe the frequency of the listed events. A global score is calculated from the sum of 7 component scores and ranges from 0-21, with lower scores indicating lower sleep dysfunction and higher scores indicating higher sleep dysfunction.
Time Frame
Assessed at baseline, week 3, and week 6 (final visit).
Title
Change in PROMIS Physical Function (PROMIS 8b) from baseline
Description
The PROMIS Physical Function (PROMIS 8b) instrument measures self-reported capability of physical activities by asking participants to respond to 8 items on a 5-point Likert scale. The scale for the first 4 items is as follows: 5- Without any difficulty, 4- With a little difficulty, 3- With some difficulty, 2- With much difficulty, 1- Unable to do. The scale for the last 4 items is as follows: 5- Not at all, 4- Very little, 3- Somewhat, 2- Quite a lot, 1- Cannot do. Raw sum scores range from 8-40 and are converted into a T-score ranging from 20.3 to 60.1, with higher scores indicating better physical function and lower scores indicating poorer physical function.
Time Frame
Assessed at baseline, week 3, and week 6 (final visit).
Title
Change in the Perceived Stress Scale (PSS) from baseline
Description
The Perceived Stress Scale (PSS) measures how different situations affect feelings and perceived stress. Participants are asked to answer 10 items that describe the frequency of their feelings and thoughts described in each item during the last month on a 0-4 point Likert scale (0 - never, 1- almost never, 2- sometimes, 3- fairly often, 4- very often). Sum scores range from 0-40, with lower scores indicating less perceived stress levels and higher scores indicating higher perceived stress levels.
Time Frame
Assessed at baseline, week 3, and week 6 (final visit).
Title
Change in the PTSD Checklist (PCL-5) from baseline
Description
The PCL-5 assesses the 20 DSM-5 symptoms of PTSD. Participants are asked to answer 5 free response questions about the worst & more stressful event to which they were exposed, then 20 items about the event on a 0-4 point Likert scale (0- not at all, 1- a little bit, 2- moderately, 3- quite a bit, 4- extremely). Sum scores of the 20 Likert-format items range from 0-80, with lower scores indicating less severe PTSD symptoms and higher scores indicating more severe PTSD symptoms.
Time Frame
Assessed at baseline, week 3, and week 6 (final visit).
Title
Change in the Pain, Enjoyment of Life, and General Activity (PEG-3) from baseline
Description
The Pain, Enjoyment of Life, and General Activity (PEG-3) scale assesses pain levels and interference with enjoyment of life and activity. Participants are asked to answer 3 items on a 0-10 point Likert scale. For item 1, the scale is as follows: 0- no pain, 10- pain as bad as you can imagine. For items 2-3, the scale is as follows: 0- does not interfere, 10- completely interferes. Sum scores range from 0-30, with lower scores indicating less pain and/or interference and higher scores indicating more pain and/or interference.
Time Frame
Assessed at baseline, week 3, and week 6 (final visit).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-50 years
Diagnosis of POTS
Can speak and read in English
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Chelimsky, M.D.
Phone
(804)-628-0145
Email
thomas.chelimsky@vcuhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Madison Maxwell, B.S.
Email
maxwellme@vcu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Chelimsky, M.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virnigia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of Improved Vagal Function on Periaqueductal Gray Connectivity
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