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Not Yet RecruitingNCT07510880

Home tDCS for the Treatment of Major Depression.

Home tDCS for the Treatment of Major Depression: A Randomised Clinical Trial

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
198 (estimated)
Sponsor
Ionclinics & Deionic SL · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The purpose of this multicentric randomized controlled trial is to compare the effectiveness and safety of home-based tDCS for the treatment of major depression versus tDCS treatment in a healthcare centre, and explore the effects of an accelerated home-tDCS protocol. The change in depression index at the end of treatment, measured with MADRS, will be the primary outcome.

Conditions

Interventions

TypeNameDescription
DEVICEAccelerated protocol of home Transcranial direct current stimulationTranscranial 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 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal 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 protocol of home Transcranial direct current stimulationTranscranial 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 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation. Dose: 9 weeks, from Monday to Friday. 1 time per day (total of 42 sessions).
DEVICEConventional protocol of in person Transcranial direct current stimulationTranscranial 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 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal region). The application of tDCS will be carried out at the medical facilities. Each session will consist of 20 minutes of stimulation. Dose: 9 weeks, from Monday to Friday. 1 time per day (total of 42 sessions).

Timeline

Start date
2026-03-23
Primary completion
2027-04-30
Completion
2027-12-31
First posted
2026-04-06
Last updated
2026-04-06

Locations

3 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT07510880. Inclusion in this directory is not an endorsement.