Standing Cognition and Co-morbidities of POTS Evaluation (SCOPE)

March 19, 2021 updated by: Amanda Miller, Milton S. Hershey Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17111
        • Penn State College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Executive Function (Stroop Word-color Test)
Time Frame: 1 hour
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.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attention Score 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.
1 hour
Number of Participants With Hypermobile Ehlers-Danlos Syndrome (hEDS)
Time Frame: 1 hour
hEDS was evaluated using the Diagnostic Criteria for hEDS checklist. The number of participants who fulfill the diagnostic criteria on the checklist are reported.
1 hour
Heart Rate Standing Minus Heart Rate Supine
Time Frame: 1 hour
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.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Collaborators

Dysautonomia International

Investigators

  • Principal Investigator: Amanda J Miller, Ph.D., Penn State College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2018

Primary Completion (Actual)

December 17, 2019

Study Completion (Actual)

December 17, 2019

Study Registration Dates

First Submitted

July 9, 2018

First Submitted That Met QC Criteria

July 25, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

April 14, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Study00009606

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postural Tachycardia Syndrome

Clinical Trials on Standing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe