EEG Prediction and Clinical Efficacy of tDCS in Major Depression

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.

Conditions

• Depression - Major Depressive Disorder

Interventions

DEVICE

High-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).

DEVICE

Conventional 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).

Sponsors & Collaborators

• Hospital Universitario Doctor Peset

  collaborator OTHER

• Universidad Europea de Valencia

  collaborator OTHER

• Ionclinics & Deionic SL

  lead INDUSTRY

Principal Investigators

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

• Mar Hernández Secorún, PhD · Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.

• Gustavo Sarriá Córdoba, MSc · Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2028-06-30

Completion

2028-12-31

Countries

• Spain

Study Locations