Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT01988883 |
Other study ID # |
131371 |
Secondary ID |
5UL1TR000445-07 |
Status |
Active, not recruiting |
Phase |
Early Phase 1
|
First received |
|
Last updated |
|
Start date |
October 2014 |
Est. completion date |
December 2024 |
Study information
Verified date |
January 2024 |
Source |
Vanderbilt University Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
A common complaint among patients with Postural Tachycardia Syndrome (POTS) is "brain fog" or
difficulty concentrating. This problem is poorly understood.
The purpose of this study is to better understand the cognitive dysfunction associated POTS,
and to determine optimal treatment strategies for this condition. In this study, the
investigators will test the hypothesis that acute administration of the psychostimulant drug
modafinil can improve seated measures of cognitive function in patients with POTS.
Description:
Postural Tachycardia Syndrome (POTS) is one of the most frequent forms of chronic orthostatic
intolerance and affects an estimated 500,000 people in the United States alone. This disorder
is a common source of disability in young adults, with a strong predilection for
premenopausal women. POTS is characterized by an excessive increase in heart rate (>30 bpm)
on assuming the upright position that is associated with orthostatic symptoms that are
relieved by lying down. These symptoms include palpitations, chest pain, lightheadedness or
dizziness, blurred vision, nausea and fatigue. In addition, POTS patients commonly report
mental clouding or "brain fog" even while lying down or seated, which can pose significant
limitations to daily life.
Although mental clouding is an almost universal complaint among POTS patients, this
phenomenon is poorly understood. As a result, the optimal treatment strategies to manage
cognitive dysfunction in this condition remain unknown. The purpose of this study is to
better define the mental clouding associated with POTS and to determine whether the
psychostimulant modafinil is a viable therapeutic option to improve cognitive function in
these patients. The investigators hypothesize that acute modafinil administration will
improve seated measures of cognitive function in POTS patients. The specific aims are:
1. To assess whether acute modafinil improves seated measures of cognitive function,
particularly measures of attention and executive function, in POTS patients compared to
placebo.
2. To assess whether propranolol, either alone as an active control or in combination with
modafinil to mitigate potential heart rate increases, can improve cognitive function in
POTS.
Patients will be studied on 4 separate days with oral administration of: placebo, modafinil
(200 mg), propranolol (20 mg) and the combination of modafinil (200 mg) and propranolol (20
mg). The order of administration will be randomized in a double-blind manner. Patients will
be seated during the study and cognitive testing will begin approximately 2.5 hours after
medication administration. Cognitive testing will consist of the CogState computerized brief
battery. Patients will also be asked to stand for 10 minutes (or as long as tolerated) at 1,
3 and 4 hours post medication, with some of the cognitive tests repeated while standing at
the 4 hour time point.