At a glance
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A Single Blind, Randomized, Sham Controlled Study of Cranial Electrical Stimulation in Bipolar II Disorder
In Brief
A clinical study evaluating Active CES and Sham CES for Bi-polar II Disorder. Completed, enrolled 16 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the antidepressant effects of Cranial Electrotherapy Stimulation (CES) in the depressed phase of bipolar II disorder.; to examine the safety of daily CES in bipolar II patients; and to examine the effects of 20 minutes of daily CES on EEG reading. The investigators hypothesize: 1. The CES will reduce symptom severity more than sham (placebo) CES. 2. That CES administered for 20 minutes daily for four weeks is safe and well tolerated when treating bipolar II patients. 3. That CES will shift the alpha and beta power fractions of EEG downward, and that this shift correlates with a decrease in level of anxiety and depression
Study Details
Timeline
Interventions
The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.
The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks.