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Looming task for Postural Orthostatic Tachycardia Syndrome

N/A
Recruiting
Led By Gisela Chelimsky, M.D.
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females 12-21 years old
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)
Must not have
Treatment with a drug or medical device within the previous 30 days that has not received regulatory approval
Inflammatory arthritis, connective tissue or auto-immune disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 minutes
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how people with POTS interpret visual info & how the brain communicates, to help doctors understand the condition better.

Who is the study for?
This trial is for females aged 12-21 with Postural Tachycardia Syndrome (POTS), who can communicate in English and give consent. Healthy girls without POTS or neurological disorders are also needed as controls. Participants should not be using certain hormones, have substance abuse issues, inflammatory/auto-immune diseases, unstable medical conditions like severe kidney/liver disease, uncontrolled psychiatric illnesses, or recent involvement in other drug/device trials.
What is being tested?
The study tests how young women with POTS process visual information ('Looming task') to understand brain communication patterns. It aims to shed light on the condition's natural history and associated problems by comparing their responses to those of healthy individuals.
What are the potential side effects?
Since this trial involves a non-invasive 'Looming task' which assesses perception rather than medication or invasive procedures, there are no direct side effects related to drugs or surgical interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a female between the ages of 12 and 21.
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I have been diagnosed with POTS, experiencing a significant heart rate increase when standing.
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I am healthy without POTS or neurological disorders.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't used unapproved drugs or devices in the last 30 days.
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I have an autoimmune, arthritis, or connective tissue condition.
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I haven't had major surgery in the last 60 days or minor procedures in the last 7 days.
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I do not have any unstable medical conditions like severe kidney, liver, heart problems, uncontrolled diabetes, or untreated mental health issues.
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I have a nerve or brain disorder such as MS, stroke, or cerebral palsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Periaqueductal gray region activation - looming task
Central gray substance of midbrain

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Adolescents without POTSExperimental Treatment1 Intervention
Group II: Adolescents with POTSExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
717 Previous Clinical Trials
22,895,662 Total Patients Enrolled
2 Trials studying Postural Orthostatic Tachycardia Syndrome
132 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Gisela Chelimsky, M.D.Principal InvestigatorVirginia Commonwealth University

Media Library

Adolescents with POTS Clinical Trial Eligibility Overview. Trial Name: NCT05618054 — N/A
Postural Orthostatic Tachycardia Syndrome Research Study Groups: Adolescents with POTS, Adolescents without POTS
Postural Orthostatic Tachycardia Syndrome Clinical Trial 2023: Adolescents with POTS Highlights & Side Effects. Trial Name: NCT05618054 — N/A
Adolescents with POTS 2023 Treatment Timeline for Medical Study. Trial Name: NCT05618054 — N/A
~13 spots leftby Dec 2025
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