Home transcranial direct current stimulation for major depression
Home tDCS for the Treatment of Major Depression: A Randomised Clinical Trial
This study tests whether doing transcranial direct current stimulation (tDCS) at home—using either an accelerated or a conventional schedule—works as well and is as safe as receiving tDCS in a clinic for adults (18–65) with major depression who speak Spanish or Catalan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 198 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ionclinics & Deionic SL Industry-sponsored |
| Locations | 3 sites (L'Hospitalet de Llobregat, Barcelona and 2 other locations) |
| Trial ID | NCT07510880 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial compares home‑based tDCS (with both an accelerated home protocol and a conventional home protocol) to conventional in‑person tDCS delivered at a healthcare center. Adults with a current major depressive episode (including unipolar major depressive disorder or bipolar disorder type 1 or 2) and a MADRS score of 15 or higher are eligible, whether or not they are taking antidepressant medication. Participants must learn to self‑apply the device and agree to supervised sessions and close safety monitoring. The primary outcome is change in MADRS score at the end of treatment, with safety and tolerability recorded throughout.
Who should consider this trial
Good fit: Adults aged 18–65 who speak Spanish or Catalan, have a current major depressive episode with MADRS ≥15, can learn to self‑administer tDCS, and are willing to attend supervised monitoring visits are ideal candidates.
Not a fit: People who do not meet the language or age criteria, have MADRS scores below 15, cannot reliably self‑apply the device or comply with supervision, or have contraindications to tDCS are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could allow safe, effective tDCS to be delivered at home, making treatment more accessible and convenient for people with depression.
How similar studies have performed: Previous randomized trials of tDCS for depression have shown modest but variable symptom reduction, and early home‑based tDCS studies are promising though not yet definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
L'Hospitalet de Llobregat, Barcelona and 2 other locations
- Hospital Universitario de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
- Hospital Universitari de Mataró — Mataró, Barcelona, Spain (Recruiting)
- Parc Taulí Hospital Universitari — Sabadell, Barcelona, Spain (Not_yet_recruiting)
Study contacts
- Study coordinator: Ane Miren Gutiérrez Muto, PhD
- Email: investigacion@ionclinics.com
- Phone: +34960606200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.