NCT03602482: SCOPE

Standing Cognition and Co-morbidities of POTS Evaluation

Completed NA Results posted Last updated 14 April 2021

What this trial tests

NA trial testing Standing in Postural Tachycardia Syndrome in 139 participants. Completed in 17 December 2019.

Timeline

23 June 2018

Primary endpoint
17 December 2019

17 December 2019

Quick facts

Lead sponsor	Milton S. Hershey Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	139
Start date	23 June 2018
Primary completion	17 December 2019
Estimated completion	17 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Standing
• Supine

Conditions studied

• Postural Tachycardia Syndrome — all drugs for Postural Tachycardia Syndrome →
• Ehlers-Danlos Syndrome — all drugs for Ehlers-Danlos Syndrome →

Sponsor

Milton S. Hershey Medical Center

Who can join

Adults 13 to 60, any sex, with Postural Tachycardia Syndrome or Ehlers-Danlos Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Executive Function (Stroop Word-color Test) Primary · 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.

Standing Stroop Scores

Group	Value	95% CI
POTS- Supine, Standing	48	± 13
POTS- Standing, Supine	49	± 10
Control- Supine, Standing	50	± 6
Control- Standing, Supine	58	± 9

Supine Stroop Scores

Group	Value	95% CI
POTS- Supine, Standing	45	± 10
POTS- Standing, Supine	54	± 12
Control- Supine, Standing	55	± 10
Control- Standing, Supine	56	± 10

Attention Score Using Cogstate Identification Task Secondary · 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.

ID test speed standing

Group	Value	95% CI
POTS- Supine, Standing	2.78	± 0.11
POTS- Standing, Supine	2.78	± 0.12
Control- Supine, Standing	2.70	± 0.05
Control- Standing, Supine	2.68	± 0.06

ID test speed supine

Group	Value	95% CI
POTS- Supine, Standing	2.74	± 0.09
POTS- Standing, Supine	2.64	± 0.40
Control- Supine, Standing	2.71	± 0.06
Control- Standing, Supine	2.70	± 0.06

Number of Participants With Hypermobile Ehlers-Danlos Syndrome (hEDS) Secondary · 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.

Group	Value	95% CI
POTS	28

Heart Rate Standing Minus Heart Rate Supine Secondary · 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.

Group	Value	95% CI
POTS	15	± 10
Control-	12	± 8

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.