Postural Tachycardia Syndrome Clinical Trial
— SCOPEOfficial title:
Standing Cognition and Co-morbidities of POTS Evaluation
Verified date | March 2021 |
Source | Milton S. Hershey Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Penn State College of Medicine | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center | Dysautonomia International |
United States,
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 |
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