NCT07444242

Accelerated Treatment of Depressive Patients With tDCS

Accelerated Treatment of Depressive Patients With tDCS (Twice Per Day) - a Placebo Controlled Home-based Treatment

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Regensburg · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Transcranial direct current stimulation	Non-invasive brain stimulation techniques, such as transcranial direct current stimulation (tDCS), have gained increasing attention in recent years in both research and the treatment of various psychiatric disorders (Alonzo et al., 2019; Lefaucher et al., 2017). Compared to other neuromodulation methods, such as transcranial magnetic stimulation (TMS), tDCS offers the advantage of mobile or outpatient use, including home-based application. tDCS devices are small, portable, and cost-effective, and they are associated with a favorable side-effect profile (Alonzo et al., 2019).

Timeline

• Start date: 2026-03-16
• Primary completion: 2026-11-30
• Completion: 2026-12-31
• First posted: 2026-03-02
• Last updated: 2026-03-02