fMRI in Postural Tachycardia Syndrome (POTS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04137757|
Recruitment Status : Not yet recruiting
First Posted : October 24, 2019
Last Update Posted : June 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Postural Tachycardia Syndrome||Other: Lower Body Negative Pressure Other: Sham Pressure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|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|
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.
- 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.
- 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.
- Blood Pressure [ Time Frame: 60 minutes ]The change in blood pressure following cognitive tasks and orthostatic stress.
- Heart Rate [ Time Frame: 60 minutes ]The change in heart rate following cognitive tasks and orthostatic stress.
- 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.
- 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.
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
|Contact: Amanda J Miller, Ph.D.||firstname.lastname@example.org|
|Contact: Amy C Arnold, Ph.D.||email@example.com|
|Principal Investigator:||Amy C Arnold, Ph.D.||Milton S. Hershey Medical Center|