Combining tDCS with a cognitive control video game training in depression: a multicenter randomized controlled trial (DiSCoVeR)

The DiSCcoVeR trial was conducted as a two-arm, double-blind, randomized controlled trial (ClinicalTrials.gov: NCT04953208) to investigate the feasibility and efficacy of a synergistic, home-based treatment for major depressive disorder (MDD). We combined transcranial prefrontal direct current stimulation (tDCS) with cognitive control-enhancing video game training using a sequence of minigames. In total, 110 patients with MDD were enrolled across three study sites (Jerusalem, Israel, Riga, Latvia, and Munich, Germany). Participants were randomized to two treatment conditions and underwent six weeks of intervention (daily sessions on weekdays, totaling 30 sessions) followed by four weeks of follow-up: 1) One group received active tDCS (anode F3, cathode F4, 2 mA intensity for 30 minutes) combined with cognitive control and emotion regulation training using a video game paradigm; 2) the control group received sham tDCS along with a control video game. Participants performed their designated treatment at the clinical center (sessions 1-5) and continue treatment at home under remote supervision (sessions 6-30). An electrode-positioning algorithm was used to standardize tDCS electrode positioning. The primary outcome was the feasibility of the combined approach, based on the percentage of patients who completed the treatment in the intention-to treat (ITT) sample. The secondary outcome was efficacy, measured by changes in Montgomery-Åsberg Depression Rating Scale (MADRS) scores from baseline to week six post-treatment. Tertiary outcomes included measures of clinical response, depression status, global functioning, quality of life, and cognitive control.
By the time of the abstract submission, patient recruitment was completed with data lock and subsequent data analysis in progress. Preliminary results from the final analysis will be presented and discussed at the conference.