Examining the synergistic effects of a cognitive control video game and a home-based, self-administered non-invasive brain stimulation on alleviating depression: the DiSCoVeR trial protocol

Esther Dechantsreiter, Frank Padberg*, Alon Morash, Ulrike Kumpf, Arthur Nguyen, Zeno Menestrina, Fabienne Windel, Gerrit Burkhardt, Stephan Goerigk, Takuya Morishita, Aldo Soldini, Shira Ahissar, Tamar Cohen, Angela Pasqualotto, Linda Rubene, Liene Konosonoka, Daniel Keeser, Peter Zill, Razan Assi, Rémy GardierRoser Viñals, Jean Philippe Thiran, Ronen Segman, Yuval Benjamini, Omer Bonne, Friedhelm Christoph Hummel, Daphne Bavelier, Elmars Rancans, Mor Nahum

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

Enhanced behavioral interventions are gaining increasing interest as innovative treatment strategies for major depressive disorder (MDD). In this study protocol, we propose to examine the synergistic effects of a self-administered home-treatment, encompassing transcranial direct current stimulation (tDCS) along with a video game based training of attentional control. The study is designed as a two-arm, double-blind, randomized and placebo-controlled multi-center trial (ClinicalTrials.gov: NCT04953208). At three study sites (Israel, Latvia, and Germany), 114 patients with a primary diagnosis of MDD undergo 6 weeks of intervention (30 × 30 min sessions). Patients assigned to the intervention group receive active tDCS (anode F3 and cathode F4; 2 mA intensity) and an action-like video game, while those assigned to the control group receive sham tDCS along with a control video game. An electrode-positioning algorithm is used to standardize tDCS electrode positioning. Participants perform their designated treatment at the clinical center (sessions 1–5) and continue treatment at home under remote supervision (sessions 6–30). The endpoints are feasibility (primary) and safety, treatment efficacy (secondary, i.e., change of Montgomery-Åsberg Depression Rating Scale (MADRS) scores at week six from baseline, clinical response and remission, measures of social, occupational, and psychological functioning, quality of life, and cognitive control (tertiary). Demonstrating the feasibility, safety, and efficacy of this novel combined intervention could expand the range of available treatments for MDD to neuromodulation enhanced interventions providing cost-effective, easily accessible, and low-risk treatment options. ClinicalTrials.gov: NCT04953208.

Original languageAmerican English
Pages (from-to)85-98
Number of pages14
JournalEuropean Archives of Psychiatry and Clinical Neuroscience
Volume273
Issue number1
DOIs
StatePublished - Feb 2023

Bibliographical note

Publisher Copyright:
© 2022, The Author(s).

Keywords

  • Cognitive control
  • Feasibility
  • Home-treatment
  • Major depressive disorder
  • Transcranial direct current stimulation (tDCS)
  • Video game

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