Clinical Trial: Modafinil and Cognitive Function in POTS

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Modafinil and Cognitive Function in Postural Tachycardia Syndrome

Brief 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.


Detailed Summary:

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.

Sponsor: Vanderbilt University

Current Primary Outcome: Visual Attention Performance Speed [ Time Frame: 2.5 hours post study medication ]

This outcome will be assessed using the CogState Identification Task which provides a continuous variable for visual attention performance speed.


Original Primary Outcome: Same as current

Current Secondary Outcome: Executive Function [ Time Frame: 2.5 hours post study medication ]

This outcome will be assessed by the CogState Groton Maze Learning and Set-Shifting Tasks which provides continuous variables for speed and accuracy measures of executive function.


Original Secondary Outcome: Stroop Test of Executive Function [ Time Frame: 2.5 hours post study medication ]

This outcome will be assessed with the Stroop Word Color test which provides a continuous variable t-score for executive function.


Information By: Vanderbilt University

Dates:
Date Received: November 13, 2013
Date Started: October 2013
Date Completion: October 2017
Last Updated: July 26, 2016
Last Verified: July 2016