Non-invasive brain stimulation and video game for depression relief
The DiSCoVeR Project: Examining the Synergistic Effects of a Cognitive Control Videogame and a Self-administered Non-invasive Brain Stimulation on Alleviating Depression
This study is testing a new treatment for depression that combines brain stimulation with a special video game to see if it helps people feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hebrew University of Jerusalem Academic / other |
| Locations | 3 sites (Munich and 2 other locations) |
| Trial ID | NCT04953208 on ClinicalTrials.gov |
What this trial studies
This trial investigates a novel treatment approach for Major Depressive Disorder (MDD) that combines transcranial direct current stimulation (tDCS) with a custom-designed video game aimed at enhancing cognitive control. Participants diagnosed with MDD will undergo a 6-week treatment regimen involving either active tDCS paired with the video game or sham tDCS with a sham game. The study is designed as a multi-site, double-blind, sham-controlled randomized controlled trial to assess both the feasibility and efficacy of this combined intervention. Follow-up assessments will occur 6 weeks post-treatment to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of Major Depressive Disorder experiencing a current episode lasting at least 4 weeks.
Not a fit: Patients with chronic depression lasting over 5 years or those who do not meet the diagnostic criteria for MDD may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, effective treatment option for patients with Major Depressive Disorder who do not respond adequately to traditional therapies.
How similar studies have performed: Previous studies have shown promise in using non-invasive brain stimulation techniques for treating depression, suggesting potential for this combined approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Men and woman 18-65 years of age. * Primary Diagnostic and Statistical Manual (DSM-5) diagnosis of Major Depressive Disorder (MDD), with a single or recurrent episode with the additional requirement of a current episode with a duration of ≥4 weeks. * Current depressive episode lasts less than 5 years (the current and previous depressive episodes are demarcated by a period of ≥2 months in which the patient did not meet full criteria for the DSM-5 definition of MDD). * Total Hamilton-21 score ≥ 13 at screening visit. * Capable and willing to provide informed consent. Patients without antidepressant medication or patients on an adequate (i.e., at least lowest effective) and stable (i.e., for ≥ 6 weeks) dosage of SSRI (Escitalopram, Citalopram, Sertralin, Paroxetin, Fluvoxamin, Fluoxetin), SSNRI (Duloxetin, Venlafaxin) or Others (Mirtazapin, Agomelatin, Vortioxetine) * Concomitant psychotherapy is allowed if ongoing for at least 3 months prior to baseline. Exclusion Criteria: * Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption). * Addiction to gaming as assessed by the Gaming Disorder Test (GDT). * Individuals diagnosed with the following psychiatric conditions (current unless otherwise stated): * Depression assessed as secondary to a general medical condition or substance-induced * Substance abuse or substance dependence (except nicotine, caffeine) in the last 6 months * Psychotic disorder (lifetime) * Bipolar disorder (I and II; lifetime) * Eating disorder if stated as primary diagnosis * Obsessive compulsive disorder if stated as primary diagnosis * Post-traumatic stress disorder if stated as primary diagnosis * Generalized anxiety disorder if stated as primary diagnosis * Panic disorder/ social anxiety if stated as primary diagnosis * Personality disorder if stated as primary diagnosis * Individuals diagnosed with a significant neurological disorder or insult including, but not limited to: * Increased intracranial pressure * Space occupying brain lesion * History of cerebrovascular accident * Transient ischemic attack within two years * Cerebral aneurysm, dementia * Parkinson's disease * Huntington's chorea * Multiple sclerosis * Epilepsy * Electroconvulsive therapy (ECT) treatment in current episode * History of tDCS, except for single tDCS sessions in experimental studies * Use of any investigational drug within 6 weeks from baseline * Suicidal risk based on MADRS item 10 score of 4-6 or attempted suicide in current episode * Acute, unstable cardiac disease * Intracranial implant or any other metal object within or near the head (excluding the mouth) that cannot be safely removed; implanted neuro-stimulators * Known or suspected pregnancy (according to pregnancy test), and women of childbearing potential not using effective contraception * History of seizures * Treatment with deep brain stimulation or vagus nerve stimulation and/or any other intracranial implants (clips, cochlear implants) * Any relevant unstable medical condition (e.g. acute, unstable cardiac disease)
Where this trial is running
Munich and 2 other locations
- Ludwig-Maximilian University — Munich, Germany (Not_yet_recruiting)
- Hadassah University Hospital — Jerusalem, Israel (Not_yet_recruiting)
- Riga Stradins University (RSU) — Riga, Latvia (Recruiting)
Study contacts
- Study coordinator: Mor Nahum, PhD
- Email: mor.nahum@mail.huji.ac.il
- Phone: 0547326655
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.