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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Depressive symptoms assessed by MADRS
研究概览
简要总结
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:
- Does the combination of VR Relaxation and tDCS at-home result in significantly greater symptom improvement in depression than tDCS alone?
- Are there differences in treatment effectiveness depending on demographic characteristics (e.g., age, gender)?
- 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)
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
tDCS only
Transcranial Direct Current Stimulation (tDCS) at home, 20 sessions, 2mA (5 days/week, for 4 weeks)
干预措施: tDCS (Device)
tDCS plus VR
Transcranial Direct Current Stimulation (tDCS) at home plus Virtual Reality (VR)-based relaxation 20 sessions, 2mA (5 days/week, for 4 weeks)
干预措施: tDCS (Device)
tDCS plus VR
Transcranial Direct Current Stimulation (tDCS) at home plus Virtual Reality (VR)-based relaxation 20 sessions, 2mA (5 days/week, for 4 weeks)
干预措施: VR-based relaxation therapy (Device)
结局指标
主要结局
Depressive symptoms assessed by MADRS
时间窗: 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)
次要结局
- 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).)
- Change in resting-state functional connectivity measured by resting-state fMRI (Fisher-z) between anterior cingulate cortex (ACC) and amygdala(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(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(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)(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)(Day 1 (baseline), Day 15 (after 2 weeks of treatment), Day 29 (after 4 weeks of treatment))
研究者
Ulrike Vogelmann
Dr. med.
Technical University of Munich