Standing Cognition and Co-morbidities of POTS Evaluation

NCT03602482 | Completed Results

• 1 other identifier: Study00009606
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Postural Tachycardia Syndrome; Ehlers-Danlos Syndrome

Keywords

postural tachycardia syndrome; cognition

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour

Secondary Outcomes (3)

• Attention Score Using Cogstate Identification Task

  1 hour

• Number of Participants With Hypermobile Ehlers-Danlos Syndrome (hEDS)

  1 hour

• Heart Rate Standing Minus Heart Rate Supine

  1 hour

Study Arms (2)

Standing

EXPERIMENTAL

Participants will complete cognitive testing while standing.

Behavioral: Standing

Supine

ACTIVE COMPARATOR

Participants will complete cognitive testing while supine.

Behavioral: Supine

Interventions

Standing BEHAVIORAL

Participants will stand and complete cognitive tests.

Standing

Supine BEHAVIORAL

Participants will complete cognitive tests while supine.

Supine

Eligibility Criteria

• Age: 13 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Dysautonomia International: collaborator

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17111, United States

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Ehlers-Danlos Syndrome

Interventions

Standing Position; Supine Position

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Amanda J. Miller
• Organization: Pennsylvania State University College of Medicine

aross1@pennstatehealth.psu.edu

7175317676

Study Officials

• Amanda J Miller, Ph.D.

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 26, 2018
• Study Start: June 23, 2018
• Primary Completion: December 17, 2019
• Study Completion: December 17, 2019
• Last Updated: April 14, 2021
• Results First Posted: April 14, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)