An interventional study of tDCS and VR-based relaxation therapy in Major Depression Moderate and Major Depression Severe, sponsored by Technical University of Munich. Enrolling by invitation at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Technical University of Munich · Not applicable, Interventional, and Treatment
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:
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:
Participant Recruitment:
Patients with unipolar or bipolar depression will be recruited from inpatient wards at Klinikum rechts der Isar and outpatient services. After screening for eligibility and obtaining informed consent, participants will be randomized into two groups (1:1), stratified by depression severity (MADRS > or \< 30):
Active Group: 4-week home-based combination therapy of tDCS and VR-based relaxation
Control Group: 4-week home-based tDCS without VR relaxation
Treatment Protocol:
at-home tDCS: 2 mA for 30 minutes, electrodes at F3/F4 (bifrontal, over DLPFC), daily Monday to Friday, total 20 sessions. Optional MRI before/after treatment.
VR Relaxation: Nature exposure via VR headset, 30 minutes daily parallel to tDCS, Monday to Friday, 20 sessions.
Assessment Schedule:
Baseline Visit (Visit 1): Informed Consent, demographics, medical history, vital signs, and baseline scales (BDI, MADRS, HDRS, GCI, GAF, CTQ, EHI, FTND). First session in-clinic with training for home use. Up to 5 additional sessions may be conducted in-clinic.
Mid-Treatment (Visit 2): After 2 weeks: vital signs, questionnaires (BDI, MADRS, HDRS, GCI, GAF), therapy adherence (according to number of conducted sessions), side effects, treatment adjustments if needed.
Final Assessment (Visit 3): After 4 weeks: final vitals, questionnaires (BDI, MADRS, HDRS, GCI, GAF), patient satisfaction survey, therapy experience interview.
Follow Up Assessment (Visit 4): After 12-16 weeks: questionnaires (BDI, MADRS, HDRS, GCI, GAF)
Technical data on tDCS use (automatic logging) including time, adherence, etc., will also be recorded.
2,740 studies on the registry are indexed under Depressive Disorder, Major; 558 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 2,282 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Transcranial Direct Current Stimulation (tDCS) at home, 20 sessions, 2mA (5 days/week, for 4 weeks)
Device: tDCS
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
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.
Nature exposure via a Virtual Reality (VR) headset, for 30 minutes daily concurrently to tDCS, Monday to Friday, for a total of 20 sessions.
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)
Time frame: Measured at day 1 (baseline) and day 29 (after the full 4 weeks of treatment).
Clinical Global Impression assessed by CGI-S
Clinical Global Impression - Severity scale (CGI-S). Outcome values are interpreted as follows: 1. \- Normal, not at all ill 2. \- Borderline mentally ill 3. \- Mildly ill 4. \- Moderately ill 5. \- Markedly ill 6. \- Severely ill 7. \- Among the most extremely ill patients
Time frame: 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
Global psychosocial functioning will be assessed using the Global Assessment of Functioning (GAF) scale. Outcome values are interpreted as follows: 91-100 Excellent No symptoms; superior functioning 81-90 Good Minimal symptoms, generally doing well 71-80 Mild Some mild symptoms or difficulties 61-70 Moderate Mild symptoms but generally functioning 51-60 Moderate to serious Moderate symptoms or difficulty in functioning 41-50 Serious Serious symptoms or impairments 31-40 Major impairment Impairment in several areas (e.g., work, school) 21-30 Severe Behavior influenced by delusions, serious communication issues 11-20 Very severe Danger to self/others, gross communication issues 1-10 Extreme Persistent danger of severely hurting self/others 0 Not assessable Insufficient information
Time frame: 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
Major Depression psychiatric symptoms assessed with the Beck Depression Inventory (BDI-II). Outcome values are interpreted as follows: 0-13 = Minimal depression, 14-19 = Mild depression, 20-28 = Moderate depression, 29-63 = Severe depression
Time frame: 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
Major Depression psychiatric symptoms assessed with the Hamilton Depression Rating Scale (HADRS). Outcome values are interpreted as follows: 0-7 = No Depression, 08-16 = mild, 17-23 = moderate, ≥ 24 = severe
Time frame: 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
Resting-state fMRI-based Pearson correlation between average BOLD time series of DLPFC and ACC, computed per scanned participant and Fisher-z-transformed. Only participants who underwent fMRI are included. Measurement tool: Resting-state fMRI on 3T MRI scanner; ROI time-series extraction and correlation analysis Unit of measure: Fisher-z (dimensionless) How aggregated: Mean Fisher-z per participant; Change score = Day 29 - Day 1.
Time frame: Measured at day 1 (baseline) and day 29 (after the full 4 weeks of treatment).
Change in resting-state functional connectivity measured by resting-state fMRI (Fisher-z) between anterior cingulate cortex (ACC) and amygdala
Resting-state fMRI-based Pearson correlation between average BOLD time series of anterior cingulate cortex (ACC) and amygdala, Fisher-z-transformed. Measurement tool: Resting-state fMRI on 3T MRI scanner; ROI time-series extraction and correlation analysis. Unit of measure: Fisher-z (dimensionless) How aggregated: Mean Fisher-z per participant; Change score = Day 29 - Day 1.
Time frame: Measured at day 1 (baseline) and day 29 (after the full 4 weeks of treatment).
Change in resting-state functional connectivity measured by resting-state fMRI (Fisher-z) between hippocampus and amygdala
Resting-state fMRI-based Pearson correlation between average BOLD time series of hippocampus and amygdala, Fisher-z-transformed. Measurement tool: Resting-state fMRI on 3T MRI scanner; ROI time-series extraction and correlation analysis. Unit of measure: Fisher-z (dimensionless) How aggregated: Mean Fisher-z per participant; Change score = Day 29 - Day 1.
Time frame: Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), and day 29 (after the full 4 weeks of treatment).
Change in resting-state functional connectivity measured by resting-state fMRI (Fisher-z) between dorsolateral prefrontal cortex (DLPFC) and hippocampus
Resting-state fMRI-based Pearson correlation between average BOLD time series of dorsolateral prefrontal cortex (DLPFC) and hippocampus, Fisher-z-transformed. Measurement tool: Resting-state fMRI on 3T MRI scanner; ROI time-series extraction and correlation analysis. Unit of measure: Fisher-z (dimensionless) How aggregated: Mean Fisher-z per participant; Change score = Day 29 - Day 1.
Time frame: Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), and day 29 (after the full 4 weeks of treatment).
Change in blood pressure (part of general physical health assessment)
Systolic blood pressure measured in mmHg. Values interpreted according to standard clinical reference ranges. Measurement tool: Standard sphygmomanometer or automated BP monitor Unit of measure: mmHg How aggregated: Mean systolic BP per participant; Change score = current day - baseline
Time frame: Measured at day 1 (baseline), day 15 (after 2 weeks of treatment), and day 29 (after the full 4 weeks of treatment).
Change in heart rate (part of general physical health assessment)
Description: Heart rate measured in beats per minute (bpm). Values interpreted according to standard clinical reference ranges. Measurement tool: Pulse oximeter, ECG, or manual measurement Unit of measure: beats per minute (bpm) How aggregated: Mean heart rate per participant; Change score = current day - baseline.
Time frame: Day 1 (baseline), Day 15 (after 2 weeks of treatment), Day 29 (after 4 weeks of treatment)
Plan to share: Yes — All anonymised study outcomes will be shared, including questionnaire, physiological, and device data.
Supporting information: Study protocol, Icf, Analytic code
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