Tiefe Hirnstimulation bei therapierefraktärem Alkoholismus (DeBraSTRA-Studie)

Primäres Ziel dieser Studie ist der Nachweis der Wirksamkeit der bilateralen Tiefen Hirnstimulation (THS) des Nucleus accumbens (NAc) bei schwerer therapierefraktärer Alkoholsucht, sekundäres Ziel ist die Dokumentation möglicher Effekte dieser Therapie auf kognitive Hirnleistungen der Patienten. Unseres Wissens nach ist dies die erste klinische Studie zur NAc-THS bei schwerer Alkoholabhängigkeit.

DeBraSTRA: Deep Brain Stimulation in Treatment Resistant Alcoholism.

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.