Modafinil and Cognitive Function in POTS

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Treatments: Armodafinil; Modafinil; Propranolol

Criteria

Inclusion Criteria:

• Males and females of all races between the ages of 18 to 60 years

• Diagnosed with POTS by the Vanderbilt Autonomic Dysfunction Center based on the following consensus criteria:(a) an increase in heart rate ≥ 30 beats per minute within 10 minutes of changing from the supine to standing position; (b) absence of orthostatic hypotension (defined as a decrease in systolic blood pressure ≥ 20 mmHg or diastolic blood pressure ≥ 10 mmHg upon standing); and (c) chronic symptoms (≥ 6 months) consistent with POTS that are worse with standing and are relieved by lying down

• Able and willing to provide informed consent

Exclusion Criteria:

• Overt causes for POTS such as acute dehydration and bed rest deconditioning

• Patients taking serotonin-norepinephrine reuptake inhibitors (SNRIs) or norepinephrine transporter (NET) inhibitors

• Known allergies or contraindications to study medications

• Pregnancy or breast-feeding

• Inability to give or withdraw informed consent

• Other factors which in the investigator's opinion would prevent the subject from completing the study protocol such as poor compliance during previous studies

• Asthma (due to the contraindication of propranolol for asthma patients)