Standing Cognition and Co-morbidities of POTS Evaluation (SCOPE)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03602482|
Recruitment Status : Active, not recruiting
First Posted : July 26, 2018
Last Update Posted : January 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Postural Tachycardia Syndrome Ehlers-Danlos Syndrome||Behavioral: Standing Behavioral: Supine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Standing Cognition and Co-morbidities of POTS Evaluation|
|Actual Study Start Date :||June 23, 2018|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Participants will complete cognitive testing while standing.
Participants will stand and complete cognitive tests.
Active Comparator: Supine
Participants will complete cognitive testing while supine.
Participants will complete cognitive tests while supine.
- Change in executive function from supine using the Stroop word-color test [ Time Frame: 1 hour ]Scores will be normalized using T-scores for predicted values based on age and education. Scores range from 0 to 100. Higher numbers indicate better cognition. Testing will be performed while participants are supine and standing.
- Change in attention from supine using Cogstate Identification Task [ Time Frame: 1 hour ]Scores are measured as speed to complete task with lower numbers indicating faster reaction time. Testing will be performed while participants are supine and standing.
- Hypermobile Ehlers-Danlos Syndrome (hEDS) evaluation [ Time Frame: 1 hour ]hEDS will be evaluated using the Diagnostic Criteria for hEDS checklist developed by the Ehlers Danlos Society.
- Change in Blood pressure [ Time Frame: 1 hour ]we will measure blood pressure using a brachial cuff while participants are supine and standing
- Change in heart rate [ Time Frame: 1 hour ]we will measure heart rate using a brachial cuff while participants are supine and standing
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): NCT03602482
|United States, Pennsylvania|
|Penn State College of Medicine|
|Hershey, Pennsylvania, United States, 17111|
|Principal Investigator:||Amanda J Miller, Ph.D.||Penn State College of Medicine|