Home tDCS for the Treatment of Major Depression.

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

• Major Depression Disorder

Interventions

DEVICE

Accelerated protocol of home Transcranial direct current stimulation

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 (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).

DEVICE

Conventional protocol of home Transcranial direct current stimulation

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 (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).

DEVICE

Conventional protocol of in person Transcranial direct current stimulation

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 (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).

Sponsors & Collaborators

• Hospital Universitari de Bellvitge

  collaborator OTHER

• Consorci Sanitari del Maresme. Hospital Universitari de Mataró

  collaborator OTHER

• Parc Taulí Hospital Universitari

  collaborator OTHER

• Ionclinics & Deionic SL

  lead INDUSTRY

Principal Investigators

• Ane Miren Gutiérrez Muto · Ionclinics & Deionics S.L.

• Mar Hernández Secorún · Ionclinics & Deionics S.L.

• Gustavo Sarriá Córdoba · Ionclinics & Deionics S.L.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-14

Primary Completion

2027-04-30

Completion

2027-12-31

Countries

• Spain

Study Locations