Virtual Reality-Augmented At-Home tDCS for Major Depression

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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)

Eligibility

Primary outcome measure(s)

• Depressive symptoms assessed by MADRS — Measured at day 1 (baseline) and day 29 (after the full 4 weeks of treatment).
  Major Depression psychiatric symptoms assessed with the Montgomery Asberg Depression Rating Scale (MADRS). MADRS values are interpreted as follows: 0-6 = No depression, 07-19 = mild, 20-34 = moderate, 35-60 = severe. Primary outcome is the Difference in MADRS Score from baseline to post-treatment visit (day 29)

Trial sites (1)

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