Remotely Non-invasive Brain Stimulation and Videogame to Alleviate Depression

Summary

Major depressive disorder (MDD) is a common, recurrent, and frequent chronic disorder. Treatment is often challenging; up to 40% of patients do not benefit sufficiently from existing antidepressant interventions including trials of medication and psychotherapy. Up to 25% of patients manifest a chronic course of illness, resulting in a need for additional treatment options.

The DiSCoVeR trial is a multi-site, double-blind, sham-controlled, proof-of concept randomized controlled trial (RCT). The study aims to investigate the feasibility and efficacy of an innovative, combined treatment approach, incorporating transcranial direct current stimulation (tDCS) along with a custom-made video game designed to enhance cognitive control in patients with major depressive disorder (MDD).

Patients diagnosis of MDD receive a 6-weeks treatment with prefrontal tDCS along with an active videogame or sham tDCS + sham game for 6 weeks. Follow-up per patient is 6 weeks following treatment. Before, during and after the treatment period different assessment scales will be conducted to record neuropsychological features and the course of symptom changes.

Conditions

• Major Depressive Disorder

Interventions

DEVICE

active tDCS

Treatment will be applied daily 5 days/week for a period of 6 weeks, which equals a tDCS stimulation for a total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.

DEVICE

sham tDCS

sham stimulation for a total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.

BEHAVIORAL

cognitive and emotional control video game

a video game targeting cognitive and emotional control. total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.

BEHAVIORAL

sham video game

a video game which does not target cognitive control, played for total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.

Sponsors & Collaborators

• Hadassah Medical Organization

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Riga Stradins University

  collaborator OTHER

• Mor Nahum

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-06-22

Primary Completion

2024-06-30

Completion

2024-12-31

Countries

• Germany
• Israel
• Latvia

Study Locations