Accelerated Treatment of Depressive Patients With tDCS (Twice Per Day) - a Placebo Controlled Home-based Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Compliance
研究概览
简要总结
A randomized, controlled three-arm study is planned to investigate the effectiveness and feasibility of an accelerated home-based tDCS application (3 weeks of transcranial direct current stimulation at home, twice daily). A total of 30 patients with depression (10 per group), who are currently not taking and have no history of taking antidepressant medication, will be randomly assigned to either an active tDCS condition, a sham (placebo) tDCS condition, or a waitlist control group. The latter two groups will receive active tDCS treatment after completion of the control phase.
This study represents a continuation of the pilot study GSUND DAHOAM (Ethics approval: 20-2091-101; Dragon et al., 2024).
详细描述
The aim of this study is to evaluate the feasibility of home-based tDCS for the accelerated treatment (twice daily) of depressive disorders (GSUND DAHOAM 2.0 = continuation of the study "GleichStrom UND Depression: Anwendung zu Hause Ohne Anreise zur Medbo"; Dragon et al., 2024).
Specifically, the study will assess feasibility (device usability, patient compliance, and usability of the video consultation), effectiveness (clinical ratings), and tolerability of this intervention in 30 patients with depression. Participants will be randomly assigned to one of three groups: active tDCS treatment, sham (placebo) tDCS treatment, or a waitlist control group (waiting period: 3 weeks). The latter two groups will subsequently receive active tDCS treatment.
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
- Single (Participant)
盲法说明
Random allocation to the three groups will be performed by chance.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sex: female, male, non-binary
- •Age: 18-70 years
- •Diagnosis of depression: no current or past psychiatric medication (current episode and history)
- •Provision of informed consent to participate
- •Sufficient proficiency in the German language
排除标准
- •Presence of contraindications for tDCS (e.g., electrical implants or metallic objects in the body such as a cardiac pacemaker or insulin pump, dermatological conditions affecting the scalp)
- •Neurological disorders (e.g., cerebrovascular events, neurodegenerative diseases, epilepsy, brain malformations, or a history of severe head injury)
- •Participation in another clinical trial on depression within the 3 months prior to treatment initiation
- •Pregnancy or breastfeeding
研究组 & 干预措施
Verum accelerated home-based tDCS
10 patients will receive active tDCS during a three-week intervention (accelerated: twice daily).
干预措施: Transcranial direct current stimulation (Device)
Sham accelerated home-based tDCS
10 patients will receive sham tDCS during a three-week intervention (accelerated: twice daily) with the opportunity to get active tDCS after study completion.
干预措施: Transcranial direct current stimulation (Device)
Waiting list
10 patients will have to wait for three weeks before the beginning ot the active tDCS intervention.
结局指标
主要结局
Compliance
时间窗: 3 weeks
Number of treatments administered (0-30 sessions, the more the better)
Course of the scores of the Major Depression Inventory
时间窗: 3 weeks
Depression rating scale (0-50, the lower the better)
Course of the scores of the Hamilton Depression rating scale (21 Items)
时间窗: 3 weeks
Depression rating scale (0-65, the lower the better)
次要结局
未报告次要终点
研究者
Berthold Langguth, MD, Ph.D.
Clinical Professor, MD, Ph.D.
University of Regensburg