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fMRI in Postural Tachycardia Syndrome (POTS)

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ClinicalTrials.gov Identifier: NCT04137757
Recruitment Status : Not yet recruiting
First Posted : October 24, 2019
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
National Center for Advancing Translational Science (NCATS)
Information provided by (Responsible Party):
Amy Arnold, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
Postural Tachycardia Syndrome Other: Lower Body Negative Pressure Other: Sham Pressure Not Applicable

Detailed Description:
A randomized, double blind, crossover study will be conducted to determine if there are differences in resting brain structure and blood oxygen perfusion in postural tachycardia syndrome (POTS) compared with healthy subjects, and to identify the pattern of brain activation produced by cognitive testing under resting conditions and in the presence of a physical challenge mimicking orthostatic stress (lower body negative pressure, LBNP). This is an outpatient study that requires a screening visit in the Clinical Research Center within the Penn State Hershey Medical Center, and if eligible, two study visits in the Penn State Center for Nuclear Magnetic Resonance Imaging involving blood oxygen level dependent functional magnetic resonance imaging (BOLD-fMRI) and cognitive tests while lying in a magnetic resonance imaging (MRI) scanner with the lower body placed in the LBNP chamber. The LBNP chamber applies suction to the lower body to pool blood in the legs and physiologically mimic what happens when standing up. Blood pressure, heart rate, and oxygen saturation will be measured throughout the study. A scan will be performed while at rest to look at the structure and blood oxygen perfusion in the brain. The LBNP or sham pressure will then be initiated, with the order determined randomly and the other stress applied at the second study visit. Once the appropriate level of pressure is achieved, brain oxygen perfusion will be measured and subjects will be asked to complete two tests of cognitive function. At the end of the cognitive tests, brain oxygen levels will be measured and the testing will end. The time inside the MRI scanner at each study visit will be approximately 45 minutes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Neural Correlates of Cognitive Dysfunction in Postural Tachycardia Syndrome
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Arm Intervention/treatment
Experimental: Lower Body Negative Pressure (LBNP)
Participants complete mental tasks and imaging while undergoing lower body negative pressure (LBNP).
Other: Lower Body Negative Pressure
Lower body negative pressure will be applied.

Sham Comparator: Sham Pressure
Participants complete mental tasks and imaging with pressure noise but no pressure.
Other: Sham Pressure
Noise will be turned on but no pressure will be applied.




Primary Outcome Measures :
  1. Cognitive Brain Region Activation [ Time Frame: 60 minutes ]
    The change in activation of cognitive brain regions measured by blood oxygen dependent functional magnetic resonance imaging following cognitive tasks and orthostatic stress.


Secondary Outcome Measures :
  1. Brain Oxygen Perfusion [ Time Frame: 60 minutes ]
    The change in brain oxygen perfusion measured by arterial spin labeling magnetic resonance imaging following cognitive tasks and orthostatic stress.

  2. Blood Pressure [ Time Frame: 60 minutes ]
    The change in blood pressure following cognitive tasks and orthostatic stress.

  3. Heart Rate [ Time Frame: 60 minutes ]
    The change in heart rate following cognitive tasks and orthostatic stress.

  4. Stroop Word-Color Score [ Time Frame: 10 minutes ]
    The change in the Stroop word-color test score following orthostatic stress and sham stress. This test measure executive function. The scores are T-scores normalized to population averages based on age and education level from 0 to 100. A higher score indicates better executive function.

  5. N-Back Score [ Time Frame: 10 minutes ]
    The change in the n-back test score of working memory following orthostatic stress and sham stress. This test has multiple scores including percent correct (0-100%) and reaction time (in milliseconds). A higher percent correct and a faster reaction time indicate better working memory.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women of all races
  • 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).
  • Capable of giving informed consent
  • Fluent in written and spoken English

Exclusion Criteria:

  • Age <18 years or >60 years
  • Pregnant or breastfeeding women
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04137757


Contacts
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Contact: Amanda J Miller, Ph.D. 7175317676 aross1@pennstatehealth.psu.edu
Contact: Amy C Arnold, Ph.D. 7175313674 aca17@psu.edu

Sponsors and Collaborators
Milton S. Hershey Medical Center
National Center for Advancing Translational Science (NCATS)
Investigators
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Principal Investigator: Amy C Arnold, Ph.D. Milton S. Hershey Medical Center
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Responsible Party: Amy Arnold, Assistant Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT04137757    
Other Study ID Numbers: Study00012860
UL1TR002014 ( U.S. NIH Grant/Contract )
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postural Orthostatic Tachycardia Syndrome
Tachycardia
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases