Mann KF. DFG - Deutsche Forschungsgemeinschaft BO799/8-1: DeBraSTRA: Deep Brain Stimulation in Treatment Resistant Alcoholism. 01/2012-09/2015.
The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the Nucleus accumbens (NAc) as a novel treatment in severe TRAA. To our knowledge, this will be the first clinical trial to assess DBS in TRAA worldwide. Prior to this study, our group treated 7 patients with severe TRAA with DBS on the basis of an off-label single patient use (5 patients in Magdeburg and 2 patients in Cologne). 4 out of the 7 patients remained completely abstinent (Follow-up up to 32 month), one patient had a short relapse after 16 months of abstinence and two patients showed a significant reduction of drinking days. Our hypothesis is based on these preliminary data and on the well-documented role of the NAc in alcoholism derived from animal models and neuroimaging studies in humans. We hypothesize that bilateral DBS of the NAc will result in a significant prolongation of time to first relapse and consequently in a substantial reduction of alcohol consumption. A total number of 30 patients with TRAA (10 each center) will be enrolled.