A Single Blind, Randomized, Sham Controlled Study of Cranial Electrical Stimulation in Bipolar II Disorder

I. ABSTRACT

Cranial electrical stimulation (CES) is a non-invasive brain stimulation technology that uses a small alternating current (1-2mA) applied to the scalp to affect brain function. The strength of the current is similar to that used by transcranial direct current stimulation (tDCS); the only difference is that in the case of CES the current is alternating. CES has been FDA sanctioned for the treatment of depression, anxiety and insomnia since 1978. CES was never subjected to the level of regulatory review now required for new technologies because it was "grandfather-ed" based on a device that predated the current FDA regulations. As a consequence, although hundreds of thousands of people have been treated with CES since its development in the 1950's, claims for its effectiveness have been largely anecdotal and the studies have been hampered by poor study design and inadequate blinding. It is important to study under well-controlled conditions whether this product, already in widespread use, is truly effective. This study will examine the efficacy of CES in treating the depressive phase of bipolar II disorder using a rigorous controlled design. It will be the first study of the use of CES in bipolar II disorder, and the first well controlled study of the antidepressant effects of CES. Because CES is already clinically available and large numbers of patients have received it (usually as an at-home, self treatment), it is important to conduct a randomized controlled trial rather than to merely replicate the anecdotal reports that already exist in the literature.

II. RESEARCH PLAN

1. Background and Rationale

Regulatory Status of CES