Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT07146269
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-28
First Post:
2025-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Reality-Augmented At-Home tDCS for Major Depression
Sponsor:
Technical University of Munich
Organization:
Study Overview
Official Title:
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VR-TMD
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:
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)
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)
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: