Standing Cognition and Co-morbidities of POTS Evaluation (SCOPE)
Primary Purpose
Postural Tachycardia Syndrome, Ehlers-Danlos Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standing
Supine
Sponsored by
About this trial
This is an interventional basic science trial for Postural Tachycardia Syndrome focused on measuring postural tachycardia syndrome, cognition
Eligibility 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
Sites / Locations
- Penn State College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Standing
Supine
Arm Description
Participants will complete cognitive testing while standing.
Participants will complete cognitive testing while supine.
Outcomes
Primary Outcome Measures
Executive Function (Stroop Word-color Test)
Testing scores are normalized using T-scores for predicted values based on age and education for each participant. Scores range from 0 to 100. Higher numbers indicate better cognition. Testing will be performed while participants are supine and standing.
Secondary Outcome Measures
Attention Score Using Cogstate Identification Task
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.
Number of Participants With Hypermobile Ehlers-Danlos Syndrome (hEDS)
hEDS was evaluated using the Diagnostic Criteria for hEDS checklist. The number of participants who fulfill the diagnostic criteria on the checklist are reported.
Heart Rate Standing Minus Heart Rate Supine
Heart rate (HR) will be measured using an arm blood pressure cuff while participants are in supine and standing postures. The difference in heart rate (HR standing - HR supine) was calculated for each participant.
Full Information
NCT ID
NCT03602482
First Posted
July 9, 2018
Last Updated
March 19, 2021
Sponsor
Milton S. Hershey Medical Center
Collaborators
Dysautonomia International
1. Study Identification
Unique Protocol Identification Number
NCT03602482
Brief Title
Standing Cognition and Co-morbidities of POTS Evaluation
Acronym
SCOPE
Official Title
Standing Cognition and Co-morbidities of POTS Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 23, 2018 (Actual)
Primary Completion Date
December 17, 2019 (Actual)
Study Completion Date
December 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
Dysautonomia International
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Tachycardia Syndrome, Ehlers-Danlos Syndrome
Keywords
postural tachycardia syndrome, cognition
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standing
Arm Type
Experimental
Arm Description
Participants will complete cognitive testing while standing.
Arm Title
Supine
Arm Type
Active Comparator
Arm Description
Participants will complete cognitive testing while supine.
Intervention Type
Behavioral
Intervention Name(s)
Standing
Intervention Description
Participants will stand and complete cognitive tests.
Intervention Type
Behavioral
Intervention Name(s)
Supine
Intervention Description
Participants will complete cognitive tests while supine.
Primary Outcome Measure Information:
Title
Executive Function (Stroop Word-color Test)
Description
Testing scores are normalized using T-scores for predicted values based on age and education for each participant. Scores range from 0 to 100. Higher numbers indicate better cognition. Testing will be performed while participants are supine and standing.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Attention Score Using Cogstate Identification Task
Description
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.
Time Frame
1 hour
Title
Number of Participants With Hypermobile Ehlers-Danlos Syndrome (hEDS)
Description
hEDS was evaluated using the Diagnostic Criteria for hEDS checklist. The number of participants who fulfill the diagnostic criteria on the checklist are reported.
Time Frame
1 hour
Title
Heart Rate Standing Minus Heart Rate Supine
Description
Heart rate (HR) will be measured using an arm blood pressure cuff while participants are in supine and standing postures. The difference in heart rate (HR standing - HR supine) was calculated for each participant.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda J Miller, Ph.D.
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17111
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Standing Cognition and Co-morbidities of POTS Evaluation
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