48
Participants
Start Date
February 28, 2014
Primary Completion Date
February 28, 2017
Study Completion Date
February 28, 2017
Active CES Device Alpha-Stim®
The Alpha-Stim® device is a Class II FDA-approved device for the delivery of cranial electrotherapy using microcurrents that are delivered via two electrodes worn on the earlobes. Active CES devices will be pre-programmed by the manufacturer to deliver a bipolar, asymmetric rectangular waveform at a current of 100 µa, a level that is generally undetectable by the wearer of the device. At these settings, the manufacturer recommends a treatment duration of 60 minutes. Participants will not be able to alter the settings in any way.
Sham Device
The inactive (sham) devices look identical to the active device but are inactivated by the manufacturer so as not to deliver any electrical current.
Tripler Army Medical Center, Honolulu
University of Virginia
OTHER
Tripler Army Medical Center
FED