Virtual Reality-Augmented At-Home tDCS for Major Depression

The goal of this clinical trial is to investigate the efficacy of combining Virtual Reality (VR)-based relaxation and Transcranial Direct Current Stimulation (tDCS) for treating Major Depression. The main questions this study aims to answer are: 1. Does the combination of VR Relaxation and tDCS at-home result in significantly greater symptom improvement in depression than tDCS alone? 2. Are there differences in treatment effectiveness depending on demographic characteristics (e.g., age, gender)? 3. Feasibility: What is the level of acceptance and adherence to the combined VR and tDCS therapy compared to tDCS alone? In a randomized controlled trial, patients will be assigned to either a tDCS + VR group or a tDCS-only group. The study protocol is the following: * On the first day, patients complete baseline questionnaires and are then randomly assigned to either the tDCS-only group or the tDCS + VR group. * Both groups perform home-based treatment five times per week for four weeks, with each session lasting 30 minutes. * After two weeks, patients return for a follow-up visit to complete questionnaires and assess adherence, side effects, and clinical progress. * At the end of the four-week treatment period, a final assessment is conducted, including questionnaires and patient feedback. * After 12-16 weeks (i.e. 2 to 3 months after the last tDCS session) Follow Up Assessment (BDI, MADRS, HDRS, GCI, GAF)

NCT Number	NCT07146269
Lead Sponsor	Technical University of Munich
Conditions	Major Depression Moderate, Major Depression Severe
Enrollment	30 participants
Start Date	2025-07-15
Primary Completion	2026-07 (estimated)
Study Completion	2026-08 (estimated)
Updated on ClinicalTrials.gov	2025-08-28