TY - JOUR
T1 - Examining the synergistic effects of a cognitive control video game and a home-based, self-administered non-invasive brain stimulation on alleviating depression
T2 - the DiSCoVeR trial protocol
AU - Dechantsreiter, Esther
AU - Padberg, Frank
AU - Morash, Alon
AU - Kumpf, Ulrike
AU - Nguyen, Arthur
AU - Menestrina, Zeno
AU - Windel, Fabienne
AU - Burkhardt, Gerrit
AU - Goerigk, Stephan
AU - Morishita, Takuya
AU - Soldini, Aldo
AU - Ahissar, Shira
AU - Cohen, Tamar
AU - Pasqualotto, Angela
AU - Rubene, Linda
AU - Konosonoka, Liene
AU - Keeser, Daniel
AU - Zill, Peter
AU - Assi, Razan
AU - Gardier, Rémy
AU - Viñals, Roser
AU - Thiran, Jean-Philippe
AU - Segman, Ronen
AU - Benjamini, Yuval
AU - Bonne, Omer
AU - Hummel, Friedhelm Christoph
AU - Bavelier, Daphne
AU - Rancans, Elmars
AU - Nahum, Mor
N1 - Funding Information:
Open Access funding enabled and organized by Projekt DEAL. The DisCoVeR project is funded by ERA NET NEURON. The NEURON ‘Network of European Funding for Neuroscience Research is established under the organization of the ERA-NET ‘European Research Area Networks’ of the European Commission. National funding agencies are the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF]) for LMU Munich, the Ministry of Health (MOH) for HUJI and Hadassah, the Swiss National Science Foundation (SNSF) for UNIGE and EPFL and the State Education and Development Agency (VIAA) of Latvia for RSU.
Funding Information:
This project was funded by the European Research Area Network (ERA-NET) NEURON 2018 Mental Disorders program.
Publisher Copyright:
© 2022, The Author(s).
PY - 2023/2
Y1 - 2023/2
N2 - 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.
AB - 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.
KW - s Major depressive disorder
KW - Cognitive control
KW - Video game
KW - Transcranial direct current stimulation (tDCS)
KW - Home-treatment
KW - Feasibility
UR - http://www.scopus.com/inward/record.url?scp=85140446051&partnerID=8YFLogxK
U2 - 10.1007/s00406-022-01464-y
DO - 10.1007/s00406-022-01464-y
M3 - Article
C2 - 36271928
SN - 0940-1334
VL - 273
SP - 85
EP - 98
JO - European Archives of Psychiatry and Clinical Neuroscience
JF - European Archives of Psychiatry and Clinical Neuroscience
IS - 1
ER -