Brainsway Deep TMS Therapy - for Brain Disorder Treatment

Cocaine Addiction - Double-Blind Placebo Control Safety and Feasibility Study

Columbia University, New York, NY, USA

2 January, 2011

A clinical trial of Brainsway®'s Deep TMS device for the treatment of cocaine withdrawal has begun at Columbia University, New York. The trial will be performed by the Research Foundation for Mental Hygiene, Inc., a research center which operates in collaboration with Columbia University. The effects of Deep TMS will be assessed using PET scanning to monitor metabolic processes in the body. The trial will follow a double-blind design with a control group.

Previous PET imaging studies have consistently shown that dopamine release, which plays a critical role in reward and motivation, is blunted in the striatum of cocaine abusers, suggesting that that there is too little dopamine signaling in this part of the brain.  Based on these findings, the next step in this line of research is to explore methods to increase striatal dopamine release using PET, and to investigate whether these methods reduce cocaine taking behavior.

Our overall plan in this study is to build on these previous studies and examine the effect of rTMS in cocaine dependence on two parameters: 1) the choice to self-administer cocaine; and 2) the effect on striatal dopamine release using PET.  A sham control group will be included.  This study will be performed on non-treatment seeking cocaine abusing subjects who perform cocaine self-administration sessions in the laboratory.  The H coil for rTMS will be used in this study because it penetrates deeper into the brain and will allow us to target the anterior cingulate and medial prefrontal cortex, which are more directly implicated in drug addiction. The rTMS will be performed in collaboration with Dr Abraham Zangen, who developed the H-coil and has published extensively on its use.  

In addition to investigating the effect of rTMS on PET imaging of the dopamine system and cocaine self-administration, we plan to investigate the potential positive effect of rTMS on cocaine use outside the laboratory using contingency management, a method used to reduce cocaine use.

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