search
Back to results

Pediatric POTS: Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?

Primary Purpose

Postural Tachycardia Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Looming task
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Postural Tachycardia Syndrome

Eligibility Criteria

12 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Females 12-18 years old Able to communicate and provide consent/assent English speaking Diagnosed with POTS (POTS will be defined standardly as a symptomatic = 40 bpm rise in heart rate on tilt table study without a drop in blood pressure and with symptoms of orthostatic intolerance clinically) Age-matched healthy control subjects: no POTS or other neurological disorders 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 - 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

Sites / Locations

  • Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Adolescents with POTS

Adolescents without POTS

Arm Description

Outcomes

Primary Outcome Measures

Periaqueductal gray region activation - looming task
Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region during the looming task
Periaqueductal gray region activation - resting
Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region while at rest

Secondary Outcome Measures

Full Information

First Posted
November 9, 2022
Last Updated
July 3, 2023
Sponsor
Virginia Commonwealth University
search

1. Study Identification

Unique Protocol Identification Number
NCT05618054
Brief Title
Pediatric POTS: Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?
Official Title
Pediatric POTS: Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
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 conducted to see how people with Postural tachycardia syndrome (POTS) make sense of the things they see. 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
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adolescents with POTS
Arm Type
Other
Arm Title
Adolescents without POTS
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Looming task
Intervention Description
Participants will be asked to look at some pictures during an fMRI scan. Participants will press a button when the image appears and rate the image as scary, neutral, or pleasant.
Primary Outcome Measure Information:
Title
Periaqueductal gray region activation - looming task
Description
Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region during the looming task
Time Frame
90 minutes
Title
Periaqueductal gray region activation - resting
Description
Functional magnetic resonance imaging (fMRI) will be performed to measure activation of the periaqueductal gray region while at rest
Time Frame
90 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Females 12-18 years old Able to communicate and provide consent/assent English speaking Diagnosed with POTS (POTS will be defined standardly as a symptomatic = 40 bpm rise in heart rate on tilt table study without a drop in blood pressure and with symptoms of orthostatic intolerance clinically) Age-matched healthy control subjects: no POTS or other neurological disorders 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 - 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gisela Chelimsky, M.D.
Phone
(804) 628-0145
Email
gisela.chelimsky@vcuhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Madison Maxwell, B.S.
Email
madison.maxwell@vcuhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisela Chelimsky, M.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pediatric POTS: Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?

We'll reach out to this number within 24 hrs