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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
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Postural Tachycardia Syndrome focused on measuring postural tachycardia syndrome, cognition

Eligibility Criteria

13 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

First Posted
July 9, 2018
Last Updated
March 19, 2021
Sponsor
Milton S. Hershey Medical Center
Collaborators
Dysautonomia International
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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

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Standing Cognition and Co-morbidities of POTS Evaluation

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