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Virtual Reality-Augmented At-Home tDCS for Major Depression

NCT07146269 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-28

No results posted yet for this study

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)

Conditions

  • Major Depression Moderate
  • Major Depression Severe

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.

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2026-07-31
Completion
2026-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07146269 on ClinicalTrials.gov