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fMRI Study for POTS (POTS Trial)

N/A
Recruiting
Led By Amy C 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
Capable of giving informed consent
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes
Awards & highlights

POTS Trial 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.Check my eligibility
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.See study design
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.

POTS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand the study and can agree to participate.
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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 a person of any gender and race.
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I am between 18 and 60 years old.

POTS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cognitive Brain Region Activation
Secondary outcome measures
Blood Pressure
Brain Oxygen Perfusion
Heart Rate
+1 more

POTS 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
320 Previous Clinical Trials
401,675 Total Patients Enrolled
1 Trials studying Postural Orthostatic Tachycardia Syndrome
20 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Milton S. Hershey Medical CenterLead Sponsor
492 Previous Clinical Trials
2,798,767 Total Patients Enrolled
1 Trials studying Postural Orthostatic Tachycardia Syndrome
139 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Amy C Arnold, Ph.D.Principal InvestigatorMilton S. Hershey Medical Center
1 Previous Clinical Trials
24 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate size of the cohort participating in this experiment?

"Affirmative. Clinicaltrials.gov shows that this experiment, which was initially posted on February 18th 2022, is still seeking participants. The trial necessitates 55 volunteers from a single medical centre to complete the study."

Answered by AI

Who has been authorized to partake in this research endeavor?

"This clinical trial seeks to recruit 55 people who are between 18 and 60 years old, suffering with postural orthostatic tachycardia syndrome."

Answered by AI

Is there an age limit for enrollment in this research project?

"The requirements for this clinical trial are that the applicant must be over 18 and no older than 60 years old. By contrast, there are 387 medical studies available to younger patients (under 18), and 1073 trials open to seniors aged 65+ respectively."

Answered by AI

Is enrollment currently open for this scientific investigation?

"Indeed, the clinicaltrials.gov database reflects that this medical trial is presently accepting volunteers. Having been posted on February 18th 2022, and edited twelve months later on December 1st of the same year, it aims to recruit fifty-five participants from a single location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
fMRI in Postural Tachycardia Syndrome
Amy Arnold 2022. "fMRI in Postural Tachycardia Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04137757.
~12 spots leftby Dec 2024
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