Project Details
Projekt
Deep Brain Stimulation in Treatment Resistant Alcoholism
Applicant
Professor Dr. Bernhard Bogerts
Subject Area
Clinical Psychiatry, Psychotherapy, Child and Adolescent Psychiatry
Term
from 2011 to 2018
Project identifier
Deutsche Forschungsgemeinschaft (DFG) - Project number 174204487
Following current treatments, over 60% alcoholics do not achieve long-term abstinence and subsequently develop severe complications. On the basis of a previous off-label study performed by our group, 7 patients with treatment resistant alcohol addiction (TRAA) have received deep brain stimulation (DBS) with very promising results; 4 remain abstinent, 1 had one short relapse after 16 months of abstinence and 2 show a significant reduction of drinking days (follow-up up to 32 months). In clinical trial funded by the BMBF (PREDICT Study) we found a highly significant correlation between the f-MRI BOLD response in the ventral striatum (NAc) and treatment outcome (time to relapse). Based on these two studies, the current trial aims to assess the efficacy of bilateral DBS of the Nucleus accumbens (NAc) in TRAA in 30 patients. We expect a significant difference in time to first relapse between the two patient groups as well as a reduction in alcohol consumption and in craving for alcohol. . Following implantation, patients will be randomized to 2 groups into a double-blind sham stimulation period (One group in the ON condition, the other in the. OFF condition) for the first 6 months followed by 12 months in ON for all patients. Post study surveillance will include clinical follow-ups every 3 months during additional 4 years. Primary outcome measure will be time to relapse in the first 6 months. This study will provide a reliable measurement of the clinical efficacy of DBS as a potential new therapeutic tool for the large number of TRAA patients.
DFG Programme
Clinical Trials
