Clinical trial NCT05618054: 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
Overall status: RECRUITING
Phase: NA
Conditions: Postural Tachycardia Syndrome
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 36
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* Females 12-21 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 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

Primary outcomes:
measure: Periaqueductal gray region activation - looming task
timeFrame: 90 minutes
measure: Periaqueductal gray region activation - resting
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Gisela Chelimsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References: