Prefrontal Cortex Transcranial Direct Current Stimulation Treatment in Alcohol Dependence Syndrome (PreCoTTA): Study Protocol for a Double- blind Randomized Sham-controlled Trial

Abstract

Background: Alcohol dependence is a significant public health problem, contributing to the global health burden. Due to its immense socio-economic burden, various psychosocial, psychological, and pharmacological approaches have attempted to alter the behaviour of the patient misusing or abusing alcohol, but their efficacy is modest at best. Therefore, there is a search for newer treatment approaches, including non-invasive brain stimulation in the management of alcohol dependence. We plan to study the efficacy of Prefrontal Cortex Transcranial direct current stimulation Treatment in Alcohol dependence syndrome (PreCoTTA).

Methods: Two hundred twenty-five male patients with alcohol dependence syndrome will be randomized into the three study arms (2 active, left dorsolateral prefrontal cortex and left orbitofrontal cortex, and 1 sham) to receive a total of 14 tDCS sessions (10 continuous and 4 booster sessions). Data will be collected from these sessions at five different time points on clinical, neuropsychological and biochemical parameters. In addition, 225 healthy age and education matched controls will be administered the neuropsychological test battery at baseline for comparison with the patient group.

Discussion: The proposed study aims to explore the use of non-invasive brain stimulation; tDCS as a treatment alternative. We also aim to overcome the methodological gaps of limited sample sizes, fewer tDCS intervention sessions, lack of long-term follow-ups to measure the sustainability of gains, and lack of comprehensive measures to track changes in functioning and abstinence after tDCS intervention. The main outcomes include clinical (reduction in cue-induced craving, time to first drink, and QFI); neuropsychological (risk-taking, impulsivity, and other neuropsychological domains), and biochemical markers (BDNF, leptin and adiponectin). The findings of the study will have translational value as they may help to improve the clinician's ability to effectively manage craving in patients with alcohol dependence syndrome. Furthermore, we will have a better understanding of the neuropsychological and biochemical effects of non-invasive brain stimulation techniques which are of interest in the comprehensive treatment of addiction disorders.

Trial registration: The study has been registered with the Clinical Trials Registry-India (CTRI/ 2020/09/027582) on September 03rd 2020.

Keywords: RCT; Transcranial direct current stimulation (tDCS); alcohol dependence; biochemical markers.; craving; india; neuropsychology; non-invasive brain stimulation.