Clinical Research Directory
Browse clinical research sites, groups, and studies.
Virtual Reality-Augmented At-Home tDCS for Major Depression
Sponsor: Technical University of Munich
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
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.
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