Study design and methodology for a multicentre, randomised controlled trial of transcranial direct current stimulation as a treatment for unipolar and bipolar depression

Angelo Alonzo; Scott Aaronson; Marom Bikson; Mustafa Husain; Sarah Lisanby; Donel Martin; Shawn M McClintock; William M McDonald; John O'Reardon; Zeinab Esmailpoor; Colleen Loo

doi:10.1016/j.cct.2016.10.002

Study design and methodology for a multicentre, randomised controlled trial of transcranial direct current stimulation as a treatment for unipolar and bipolar depression

Contemp Clin Trials. 2016 Nov:51:65-71. doi: 10.1016/j.cct.2016.10.002. Epub 2016 Oct 15.

Authors

Affiliations

¹ School of Psychiatry, University of New South Wales/Black Dog Institute, Sydney, NSW, Australia. Electronic address: a.alonzo@unsw.edu.au.
² Sheppard Pratt Health System, Clinical Research Programs, Baltimore, MD, USA.
³ Department of Biomedical Engineering, City College of New York, New York, NY, USA.
⁴ Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX, USA; Department of Psychiatry and Behavioural Sciences, Duke University School of Medicine, Durham, NC, USA.
⁵ Department of Psychiatry and Behavioural Sciences, Duke University School of Medicine, Durham, NC, USA; Division of Translational Research, and Noninvasive Neuromodulation Unit, Experimental Therapeutics and Pathophysiology Branch, NIMH, NIH, Bethesda, MD, USA.
⁶ School of Psychiatry, University of New South Wales/Black Dog Institute, Sydney, NSW, Australia.
⁷ Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.
⁸ Rowan University School of Osteopathic Medicine, Cherry Hill, NJ, USA.

PMID: 27756567
DOI: 10.1016/j.cct.2016.10.002

Abstract

Transcranial Direct Current Stimulation (tDCS) is a new, non-invasive neuromodulation approach for treating depression that has shown promising efficacy. The aim of this trial was to conduct the first international, multicentre randomised controlled trial of tDCS as a treatment for unipolar and bipolar depression. The study recruited 120 participants across 6 sites in the USA and Australia. Participants received active or sham tDCS (2.5mA, 20 sessions of 30min duration over 4weeks), followed by a 4-week open label active treatment phase and a 4-week taper phase. Mood and neuropsychological outcomes were assessed with the primary antidepressant outcome measure being the Montgomery-Asberg Depression Rating Scale (MADRS). A neuropsychological battery was administered to assess safety and examine cognitive effects. The study also investigated the possible influence of genetic polymorphisms on outcomes. The trial was triple-blinded. Participants, tDCS treaters and study raters were blinded to each participant's tDCS group allocation in the sham-controlled phase. Specific aspects of tDCS administration, device operation and group allocation were designed to optimise the integrity of blinding. Outcome measures will be tested using a mixed effects repeated measures analysis with the primary factors being Time as a repeated measure, tDCS condition (sham or active) and Diagnosis (unipolar or bipolar). A restricted number of random and fixed factors will be included as required to account for extraneous differences. As a promising treatment, tDCS has excellent potential for translation into widespread clinical use, being cost effective, portable, easy to operate and well tolerated.

Keywords: Bipolar; Depression; Neurostimulation; Transcranial direct current stimulation.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Bipolar Disorder / psychology
Bipolar Disorder / therapy*
Depression / psychology
Depression / therapy*
Depressive Disorder, Major / psychology
Depressive Disorder, Major / therapy*
Double-Blind Method
Humans
Transcranial Direct Current Stimulation / methods*
Treatment Outcome