Standing Cognition and Co-morbidities of POTS Evaluation

Postural Tachycardia Syndrome Clinical Trial

— SCOPE  

Official title:

Standing Cognition and Co-morbidities of POTS Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03602482
• Other study ID #: Study00009606
• Status: Completed
• Phase: N/A
• Start date: June 23, 2018
• Est. completion date: December 17, 2019

Study information

• Verified date: March 2021
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: December 17, 2019
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Ehlers-Danlos Syndrome
• Postural Orthostatic Tachycardia Syndrome
• Postural Tachycardia Syndrome
• Syndrome
• Tachycardia

Intervention

Behavioral:
• Standing
Participants will stand and complete cognitive tests.
• Supine
Participants will complete cognitive tests while supine.

Locations

Country	Name	City	State
United States	Penn State College of Medicine	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Dysautonomia International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 hour
Secondary	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.	1 hour
Secondary	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.	1 hour