Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age12-21
SponsorVirginia Commonwealth University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Looming task

    Behavioral

    Participants will be asked to look at some pictures during an fMRI scan. Participants will press a button as soon as they see the image appear.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Adolescents with POTSOther 1 intervention
Group B: Adolescents without POTSOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
90 minutes
2

Periaqueductal gray region activation - resting

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

Time frame
90 minutes

Secondary outcomes

Other outcomes

Sponsors and contacts

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