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Completed

NCT Number: NCT03602482

Standing Cognition and Co-morbidities of POTS Evaluation

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.

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Key information

Conditions

Postural Tachycardia Syndrome Autonomic Nervous System Diseases Cardiovascular Diseases Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Ehlers-Danlos Syndrome Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Nervous System Diseases Orthostatic Intolerance Postural Orthostatic Tachycardia Syndrome Primary Dysautonomias Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Vascular Diseases

Age range

13 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State College of Medicine

Hershey, Pennsylvania, 17111, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standing

Behavioral

Participants will stand and complete cognitive tests.

Supine

Behavioral

Participants will complete cognitive tests while supine.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Dysautonomia International

Registry information

Acronym: SCOPE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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