Home tDCS for the Treatment of Major Depression.
1 other identifier
interventional
198
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2026
CompletedFirst Posted
Study publicly available on registry
April 6, 2026
CompletedStudy Start
First participant enrolled
April 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
May 1, 2026
April 1, 2026
1 year
March 6, 2026
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (14)
MADRS
2nd week of treatment.
MADRS
3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.
HDRS-17
End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.
HDRS-17
2nd week of treatment.
HDRS-17
3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.
- +9 more secondary outcomes
Other Outcomes (3)
Patient Expectations
Baseline
Adverse Effect
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
Through study completion, an average of 2 years
Study Arms (3)
Accelerated home tDCS
EXPERIMENTALHome tDCS applied over 3 weeks (42 sessions)
Conventional home tDCS
ACTIVE COMPARATORHome tDCS applied over 9 weeks (42 sessions)
Conventional ambulatory tDCS
ACTIVE COMPARATORAmbulatory tDCS applied over 9 weeks (42 sessions)
Interventions
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).
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).
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ionclinics & Deionic SLlead
- Consorci Sanitari del Maresme. Hospital Universitari de Matarócollaborator
- Parc Taulí Hospital Universitaricollaborator
- Hospital Universitari de Bellvitgecollaborator
Study Sites (3)
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08304, Spain
Hospital Universitari de Mataró
Mataró, Barcelona, 08304, Spain
Parc Taulí Hospital Universitari
Sabadell, Barcelona, 08208, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Although it is impossible to blind participants due to the nature of the study, the evaluator and statistician will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2026
First Posted
April 6, 2026
Study Start
April 14, 2026
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.