Home tDCS for the Treatment of Major Depression.

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

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.

Study Overview

• Status: Recruiting
• Conditions: Major Depression Disorder
• Intervention / Treatment: Device: Accelerated protocol of home Transcranial direct current stimulation; Device: Conventional protocol of in person Transcranial direct current stimulation; Device: Conventional protocol of home Transcranial direct current stimulation

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ane Miren Gutiérrez Muto, PhD; Phone Number: +34960606200; Email: investigacion@ionclinics.com
• Study Contact Backup: Name: Ensayos Ionclincs; Phone Number: +34674059324; Email: ensayos@ionclinics.com

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08304
      • Recruiting
      • Hospital Universitario de Bellvitge
      • Contact: Ionclinics; Phone Number: +34674059324; Email: ensayos@ionclinics.com
    • Mataró, Barcelona, Spain, 08304
      • Recruiting
      • Hospital Universitari de Mataró
      • Contact: Ionclinics; Phone Number: +34674059324; Email: ensayos@ionclinics.com
    • Sabadell, Barcelona, Spain, 08208
      • Not yet recruiting
      • Parc Tauli Hospital Universitari
      • Contact: Ionclinics; Phone Number: +34674059324; Email: ensayos@ionclinics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Spanish or Catalan speakers of both sexes between the ages of 18 and 65.
• Patients diagnosed with major depression, based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Specifically, patients will be included who meet the criteria for a major depressive episode with a longitudinal diagnosis of major depressive disorder, single or recurrent episode; or bipolar disorder type 1 or 2. Patients must obtain a moderate or higher score, therefore we establish a lower limit of 15 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Alonzo et al., 2019).
• Patients receiving or not receiving pharmacological treatment for depression will be included, and this will be recorded as an additional variable.
• Have the ability and willingness to commit to the study team for supervision of the intervention sessions and close monitoring of safety.
• Demonstrate the acquisition of the ability to properly apply home tDCS independently or with the help of a companion.

Exclusion Criteria:

• Patients with psychotic, schizoaffective, or personality disorders (both cluster A and B).
• Patients with a history of neurological disease, intellectual disability, or cognitive impairment (inability to understand instructions or operate equipment).
• Any exclusion criteria established by clinical guidelines on non-invasive brain stimulation (Woods et al., 2016): metal implants or head injuries, any electronic devices such as cochlear implants or cardiac pacemakers. Brain stimulation in the last 6 months. Clinical or family history of epilepsy.
• Patients with dermatological problems, such as an allergic skin reaction at the electrode site.
• High risk of suicide. Assessed through an interview with a psychiatrist and the use of the Spanish-validated Columbia Suicide Risk Scale (C-SSRS) (Al-Halabí et al., 2016).
• Drug or alcohol abuse during the study or in the previous 3 months (except for nicotine).
• Changes in pharmacological or non-pharmacological treatment (such as structured psychotherapy) during the study or in the 3 months prior to starting the trial.
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Accelerated home tDCS; Home tDCS applied over 3 weeks (42 sessions)	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).
Active Comparator: Conventional home tDCS; Home tDCS applied over 9 weeks (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).
Active Comparator: Conventional ambulatory tDCS; Ambulatory tDCS applied over 9 weeks (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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MADRS	Mean score change based on Montgomery-Asberg Depression Rating Scale (MADRS) of the three arms at the end of the treatment compared to baseline.	End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MADRS	Mean score change based on Montgomery-Asberg Depression Rating Scale (MADRS) of the three arms at the end of the second week of treatment compared to baseline.	2nd week of treatment.
MADRS	Mean score change based on Montgomery-Asberg Depression Rating Scale (MADRS) of the three arms at 3 months post-treatment compared to baseline.	3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.
HDRS-17	Mean score change based on Hamilton Depression Rating Scale (HDRS) of the three arms at the end of the treatment compared to baseline.	End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.
HDRS-17	Mean score change based on Hamilton Depression Rating Scale (HDRS-17) of the three arms at the end of the second week of treatment compared to baseline.	2nd week of treatment.
HDRS-17	Mean score change based on Hamilton Depression Rating Scale (HDRS-17) scores of the three arms at 3 months compared to baseline compared to baseline.	3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.
HARS	Mean score change based on Hamilton Anxiety Rating Scale (HARS) of the three arms at the end of the treatment compared to baseline.	End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.
HARS	Mean score change based on Hamilton Anxiety Rating Scale (HARS) of the three arms at the end of the second week of treatment compared to baseline.	2nd week of treatment.
HARS	Mean score change based on Hamilton Anxiety Rating Scale (HARS) scores of the three arms at 3 months compared to baseline compared to baseline.	3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.
PHQ9	Mean score change based on Patient Health Questionnaire-9 (PHQ9) of the three arms at the end of the treatment compared to baseline.	End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.
PHQ9	Mean score change based on Patient Health Questionnaire-9 (PHQ9) of the three arms at the end of the second week of treatment compared to baseline.	2nd week of treatment.
PHQ9	Mean score change based on Patient Health Questionnaire-9 (PHQ9) scores of the three arms at 3 months compared to baseline compared to baseline.	3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.
Clinical Global Impression	Score based on Clinical Global Impression of the three arms at the end of the treatment.	End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.
Clinical Global Impression	Score based on Clinical Global Impression of the three arms at the end of the second week of treatment.	2nd week of treatment.
Clinical Global Impression	Score based on Clinical Global Impression of the three arms at 3 months compared to baseline.	3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Expectations	Likert scale from 1 to 5 (where 1 is no expectation and 5 is the highest possible expectation) to study the influence of expectation on the effect of treatment.	Baseline
Adverse Effect	A daily questionnaire about adverse effects will be completed at the end of the last intervention of the day.	End-of-day application (Experimental: from Monday to Sunday through 3 weeks; Active Comparator: From Monday to Friday, through 9 weeks).
Success of the blinding	A method 2 x 3 will be used to evaluate the success of the study's evaluator and statistician.	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Ionclinics & Deionic SL
• Collaborators: Hospital Universitari de Bellvitge; Parc Taulí Hospital Universitari; Consorci Sanitari del Maresme. Hospital Universitari de Mataró
• Investigators: Study Director: Ane Miren Gutiérrez Muto, Ionclinics & Deionics S.L.; Study Chair: Mar Hernández Secorún, Ionclinics & Deionics S.L.; Study Chair: Gustavo Sarriá Córdoba, Ionclinics & Deionics S.L.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Transcranial Direct Current Stimulation; Electric Stimulation Therapy; Major Depression
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: PI_2025_05_14_V4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In accordance with the recommendations of the International Committee of Medical Journal Editors, the de-identified individual participant data (IPD) that underlie the results reported in this study will be shared. The data will become accessible one year after the publication of the primary results and will remain available for five years. Access will be provided to researchers who inquire and agree to a data-use agreement through Ionclinics (investigacion@ionclinics.com/ensayos@ionclinics.com). The data will be de-identified and shared in accordance with applicable regulations and the informed consent provided by the participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No