fMRI in Postural Tachycardia Syndrome
POTS
Neural Correlates of Cognitive Dysfunction in Postural Tachycardia Syndrome
2 other identifiers
interventional
21
1 country
1
Brief Summary
Postural tachycardia syndrome (POTS) is one of the most common forms of chronic orthostatic intolerance in the United States. This is a disabling disorder characterized by an excessive increase in heart rate upon standing that is accompanied by symptoms such as dizziness and fatigue. One of the most under appreciated and bothersome symptoms of POTS is impaired cognition or "brain fog," which occurs to a level that interferes with daily activities such as work and education. Despite this high impact, the reasons why POTS patients have problems with cognition are not well understood. This project will test the overall hypothesis that "brain fog" in POTS is related to increased activation of cognitive brain regions during mental tasks when compared with healthy subjects, and that this activation is exacerbated by in the presence of orthostatic stress.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2019
CompletedFirst Posted
Study publicly available on registry
October 24, 2019
CompletedStudy Start
First participant enrolled
February 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
September 19, 2025
September 1, 2025
4.8 years
October 22, 2019
September 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Cognitive Brain Region Activation
The change in activation of cognitive brain regions measured by blood oxygen dependent functional magnetic resonance imaging following cognitive tasks and orthostatic stress.
60 minutes
Secondary Outcomes (4)
Brain Oxygen Perfusion
60 minutes
Blood Pressure
60 minutes
Heart Rate
60 minutes
Stroop Word-Color Score
10 minutes
Study Arms (2)
Lower Body Negative Pressure (LBNP)
EXPERIMENTALParticipants complete mental tasks and imaging while undergoing lower body negative pressure (LBNP).
Sham Pressure
SHAM COMPARATORParticipants complete mental tasks and imaging with pressure noise but no pressure.
Interventions
Lower body negative pressure will be applied.
Eligibility Criteria
You may qualify if:
- Men and women of all races or ethnicity
- Age 18-60
- 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).
- Healthy participants must have cognitive testing scores within normal range (defined by Stroop word-color test score between 40-70) and be able to tolerate lower body negative pressure.
- POTS participants must have either mild cognitive dysfunction (defined by Stroop word-color t-score \<40 and \>30) or normal cognitive function (defined by Stroop word-color test score between 40-70), and able to tolerate lower body negative pressure.
- Capable of giving informed consent
- Fluent in written and spoken English
You may not qualify if:
- Age \<18 years or \>60 years
- Pregnant or breastfeeding women
- Left handedness
- Require glasses for vision correction (contact lenses are okay)
- Current smokers
- Alcohol or drug abuse
- Recreational drug use (e.g. cannabis, heroin, cocaine)
- Other potential causes for tachycardia (e.g. prolonged bed rest, dehydration)
- Taking selective norepinephrine reuptake inhibitors or stimulant medications within the past 3 months as these may alter cognition
- Unable to tolerate an MRI scanner (e.g. claustrophobia, implanted metal)
- Unable to give or withdraw informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Arnold, Ph.D.
Pennsylvania State University College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 22, 2019
First Posted
October 24, 2019
Study Start
February 18, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share