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N/A

fMRI Study for POTS (POTS Trial)

N/A
Recruiting
Led By Amy Arnold, Ph.D.
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy volunteers or previously diagnosed with POTS by current consensus criteria (rise in heart rate of at least 30 beats/minute within 10 minutes of standing; absence of orthostatic hypotension defined as a drop in blood pressure greater than 20/10 mmHg within 3 minutes of standing; and presence of daily orthostatic symptoms for at least 6 months such as lightheadedness, dizziness, nausea, and palpitations)
Age 18-60
Must not have
Unable to give or withdraw informed consent
Age <18 years or >60 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes

Summary

This trial will test whether people with POTS have more difficulty with cognition than healthy subjects, and whether this difficulty is worsened by standing.

Who is the study for?
This trial is for adults aged 18-60 who either have POTS or are healthy volunteers. Participants must not be pregnant, left-handed, need glasses (contacts okay), smoke, abuse substances, or have other tachycardia causes. They should be fluent in English and able to consent.
What is being tested?
The study examines if 'brain fog' in POTS patients is due to increased brain activity during mental tasks under stress. It uses fMRI scans with two interventions: Lower Body Negative Pressure and a fake (sham) pressure as a control.
What are the potential side effects?
There may be discomfort from lying down in the MRI scanner for long periods and potential feelings of claustrophobia. The lower body negative pressure might cause temporary dizziness or lightheadedness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am healthy or have been diagnosed with POTS based on heart rate changes and symptoms.
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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand or decide about participating in this study.
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I am younger than 18 or older than 60.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 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
Cognitive Brain Region Activation
Secondary study objectives
Blood Pressure
Brain Oxygen Perfusion
Heart Rate
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lower Body Negative Pressure (LBNP)Experimental Treatment1 Intervention
Participants complete mental tasks and imaging while undergoing lower body negative pressure (LBNP).
Group II: Sham PressurePlacebo Group1 Intervention
Participants complete mental tasks and imaging with pressure noise but no pressure.

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
359 Previous Clinical Trials
411,203 Total Patients Enrolled
1 Trials studying Postural Orthostatic Tachycardia Syndrome
20 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Milton S. Hershey Medical CenterLead Sponsor
508 Previous Clinical Trials
2,796,309 Total Patients Enrolled
1 Trials studying Postural Orthostatic Tachycardia Syndrome
139 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Amy Arnold, Ph.D.Principal InvestigatorPennsylvania State University College of Medicine

Media Library

fMRI (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT04137757 — N/A
Postural Orthostatic Tachycardia Syndrome Research Study Groups: Sham Pressure, Lower Body Negative Pressure (LBNP)
Postural Orthostatic Tachycardia Syndrome Clinical Trial 2023: fMRI Highlights & Side Effects. Trial Name: NCT04137757 — N/A
fMRI (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04137757 — N/A
~15 spots leftby Dec 2025
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