RecruitingNot ApplicableNCT07611773

EEG Prediction and Clinical Efficacy of tDCS in Major Depression

Clinical Efficacy of tDCS in Major Depression: A Controlled Clinical Trial and Analysis of Electrophysiological Biomarker Predictors

Sponsor

Ionclinics & Deionic SL

Enrollment

270 participants

Start Date

Jun 14, 2026

Study Type

INTERVENTIONAL

Conditions

Depression - Major Depressive Disorder

Summary

The purpose of this randomized controlled trial is to investigate the non-inferiority, and possible superiority, of a high-dose home-based tDCS protocol compared with a conventional home-based protocol, and to assess its cost-effectiveness, in patients with major depression. As a secondary aim, we aim to assess the predictive value of baseline EEG for clinical response to high-dose home-based tDCS treatment in patients with major depression.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Conventional home-tDCS and a medical device called High-dose home-tDCS for people with depression - major depressive disorder. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHigh-dose home-tDCS

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (left dorsolateral prefrontal region) and the cathode to F8 (right supraorbital region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation. Dose: 3 weeks, daily. (1) 1st week - 3 times per day; (2) 2nd Week - 2 times per day; (3) 3rd week - 1 time per day (total of 42 sessions).

DEVICEConventional home-tDCS

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (left dorsolateral prefrontal region) and the cathode to F4 (left dorsolateral prefrontal region), described by Woodham et al., 2024. The application of tDCS will be carried out at home in this group. Each session will consist of 30 minutes of stimulation. Dose: (1) Week 1 to 3: 1ss/day for 5 days; (2) Week 4 to 10: 1ss/day for 3 days (total 36 sessions).