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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
Sponsor:
Collaborator:
Dysautonomia International
Information provided by (Responsible Party):
Amanda Miller, Milton S. Hershey Medical Center

Brief Summary:
The purpose of this study is to evaluate cognition in patients with postural tachycardia syndrome (POTS) while lying down and standing and to assess the prevalence of hypermobile Ehlers-Danlos Syndrome in POTS.

Condition or disease Intervention/treatment Phase
Postural Tachycardia Syndrome Ehlers-Danlos Syndrome Behavioral: Standing Behavioral: Supine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standing
Participants will complete cognitive testing while standing.
Behavioral: Standing
Participants will stand and complete cognitive tests.

Active Comparator: Supine
Participants will complete cognitive testing while supine.
Behavioral: Supine
Participants will complete cognitive tests while supine.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Change in Blood pressure [ Time Frame: 1 hour ]
    we will measure blood pressure using a brachial cuff while participants are supine and standing

  4. Change in heart rate [ Time Frame: 1 hour ]
    we will measure heart rate using a brachial cuff while participants are supine and standing



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Previously diagnosed with POTS, or healthy control
  • Age between 13-60 years
  • Participants may be any race, ethnicity, sex, or gender
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Inability to give, or withdrawal of, informed consent
  • Age ≤ 13 or ≥ 61 years
  • Prisoners
  • Unable to stand

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): NCT03602482


Locations
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United States, Pennsylvania
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17111
Sponsors and Collaborators
Milton S. Hershey Medical Center
Dysautonomia International
Investigators
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Principal Investigator: Amanda J Miller, Ph.D. Penn State College of Medicine
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Responsible Party: Amanda Miller, Postdoctoral Fellow, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03602482    
Other Study ID Numbers: Study00009606
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amanda Miller, Milton S. Hershey Medical Center:
postural tachycardia syndrome
cognition
Additional relevant MeSH terms:
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Postural Orthostatic Tachycardia Syndrome
Tachycardia
Ehlers-Danlos Syndrome
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
Hemostatic Disorders
Vascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases