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ENROLLING BY INVITATION
NCT07146269
NA

Virtual Reality-Augmented At-Home tDCS for Major Depression

Sponsor: Technical University of Munich

View on ClinicalTrials.gov

Summary

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)

Official title: Effectiveness of Virtual Reality-Based Relaxation as an Adjunctive Therapy to Optimize At-Home Transcranial Direct Current Stimulation (tDCS) for Depression: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-07-15

Completion Date

2026-08

Last Updated

2025-08-28

Healthy Volunteers

No

Interventions

DEVICE

tDCS

Transcranial Direct Current Stimulation delivered at an intensity of 2 mA over electrodes at F3/F4 (bifrontal, over DLPFC), for 30 minutes a day, Monday to Friday, for a total 20 sessions.

DEVICE

VR-based relaxation therapy

Nature exposure via a Virtual Reality (VR) headset, for 30 minutes daily concurrently to tDCS, Monday to Friday, for a total of 20 sessions.

Locations (1)

Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy

Munich, Germany