NCT07146269Enrolling by invitation
Virtual Reality-Augmented At-Home tDCS for Major Depression
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
Source: ClinicalTrials.gov · Last updated 28 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 14 Aug 2025
- Start date
- 15 Jul 2025
- Primary completion date
- Jul 2026
- Lead sponsor
- Technical University of Munich
- Diseases
- Depression
- NCT number
- NCT07146269
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 15 Jul 2025 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Substance use disorders within the last 3 months prior to study entry (excluding nicotine and caffeine dependence).
Other illness
- Currently clinically relevant Axis II disorders.
- Other relevant Axis I disorders (except anxiety disorders).
Other
- Skin lesions at the site of tDCS electrode placement.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.