Virtual Reality-Augmented At-Home tDCS for Major Depression

NCT07146269 | Enrolling By Invitation

• 1 other identifier: RWNM_tDCS_VR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

Non-invasive Brain Stimulation (NIBS); Major Depression; Virtual Reality (VR); Transcranial Direct Current Stimulation (tDCS); tDCS at-home

Outcome Measures

Primary Outcomes (1)

• Depressive symptoms assessed by MADRS

  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)

  Measured at day 1 (baseline) and day 29 (after the full 4 weeks of treatment).

Secondary Outcomes (10)

• Clinical Global Impression assessed by CGI-S

  Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), day 29 (after the full 4 weeks of treatment) and followup in 2-3 Months (after 12-16 weeks of treatment).

• Psychosocial functioning assessed by GAF score

  Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), day 29 (after the full 4 weeks of treatment) and followup in 2-3 Months (after 12-16 weeks of treatment).

• Depressive symptoms assessed by BDI-II

  Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), day 29 (after the full 4 weeks of treatment) and followup in 2-3 Months (after 12-16 weeks of treatment).

• Depressive symptoms assessed by HDRS

  Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), day 29 (after the full 4 weeks of treatment) and followup in 2-3 Months (after 12-16 weeks of treatment).

• Change in resting-state functional connectivity measured by resting-state fMRI (Fisher-z) between dorsolateral prefrontal cortex (DLPFC) and anterior cingulate cortex (ACC) in a subset of participants

  Measured at day 1 (baseline) and day 29 (after the full 4 weeks of treatment).

Study Arms (2)

tDCS only

ACTIVE COMPARATOR

Transcranial Direct Current Stimulation (tDCS) at home, 20 sessions, 2mA (5 days/week, for 4 weeks)

Device: tDCS

tDCS plus VR

EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS) at home plus Virtual Reality (VR)-based relaxation 20 sessions, 2mA (5 days/week, for 4 weeks)

Device: tDCS; Device: VR-based relaxation therapy

Interventions

tDCS DEVICE

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.

tDCS only; tDCS plus VR

VR-based relaxation therapy DEVICE

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

tDCS plus VR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least a moderate depressive episode (MADRS baseline score ≥ 20).
• Patients aged between 18 and 65 years.
• Sufficient cognitive abilities to understand study requirements and instructions (MMSE ≥ 27).
• Stable antidepressant/psychiatric medication for at least two weeks prior to study entry.

You may not qualify if:

• Currently clinically relevant Axis II disorders.
• Other relevant Axis I disorders (except anxiety disorders).
• Substance use disorders within the last 3 months prior to study entry (excluding nicotine and caffeine dependence).
• Skin lesions at the site of tDCS electrode placement.

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

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

Munich, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 28, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: IPD and supporting information will be made available immediately after the publication of study results, for an unrestricted duration.
• Access Criteria: The de-identified individual patient data, i.e., all IPD that underlie results in a publication, will be made accessible after its publication for non-commercial academic projects that have a legitimate research topic and a clearly stated hypothesis. In the event that the application is accepted, researchers will be asked to get the study approved by their institution's ethics board. The study principal investigator will subsequently provide the de-identified data sets via a safe data transfer system.

Locations

DE (1)