Actively Recruiting
Home tDCS for the Treatment of Major Depression: A Randomised Clinical Trial
Led by Ionclinics & Deionic SL · Updated on 2026-05-01
198
Participants Needed
3
Research Sites
35 weeks
Total Duration
On this page
Sponsors
I
Ionclinics & Deionic SL
Lead Sponsor
H
Hospital Universitari de Bellvitge
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of home-based transcranial direct current stimulation (tDCS) for treating major depression. This randomized controlled trial compares home tDCS with tDCS delivered in a healthcare center and explores the impact of an accelerated home tDCS schedule. The main measure of success is the change in depression severity at the end of treatment, assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS). The study has three treatment groups: an accelerated home tDCS protocol applied over 3 weeks with 42 sessions, a conventional home tDCS protocol over 9 weeks with 42 sessions, and conventional ambulatory tDCS in a medical facility over 9 weeks with 42 sessions. Each session uses a weak direct current of 2 mA applied to specific brain areas for 20 minutes. The accelerated home group receives multiple daily sessions initially, reducing frequency over three weeks, while the other groups have daily sessions Monday to Friday for nine weeks. Participants will be monitored closely during the study through regular assessments including depression rating scales at several time points, such as after 2 weeks, at the end of treatment, and during follow-up months later. Safety and treatment adherence will be supervised, and secondary measures include anxiety and global impression scores. The total participation period varies by group but includes treatment and follow-up visits extending up to 21 weeks. This study is sponsored by Ionclinics & Deionic SL.
CONDITIONS
Brief Title
Home tDCS for the Treatment of Major Depression.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Spanish or Catalan speakers aged 18 to 65 of any sex
- Diagnosed with major depression or bipolar disorder type 1 or 2 according to DSM-5
- Moderate or higher depression score (at least 15 points on MADRS)
- May or may not be receiving medication for depression
- Able and willing to commit to study supervision and safety monitoring
- Able to properly apply home tDCS independently or with help
You will not qualify if you...
- Diagnosis of psychotic, schizoaffective, or personality disorders
- History of neurological disease, intellectual disability, or cognitive impairment
- Metal implants, head injuries, electronic devices like pacemakers, or brain stimulation in last 6 months
- Clinical or family history of epilepsy
- Dermatological problems at electrode site
- High suicide risk as assessed by psychiatrist and suicide risk scale
- Drug or alcohol abuse during the study or in previous 3 months (except nicotine)
- Changes in pharmacological or non-pharmacological treatment in last 3 months or during study
- Pregnancy
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 to 9 weeks depending on the assigned protocol
Participants receive transcranial direct current stimulation (tDCS) sessions either at home or in medical facilities. Sessions involve 20 minutes of stimulation applying a weak direct current to the scalp using electrodes.
Daily sessions at home or in person: Accelerated home tDCS for 3 weeks with 42 total sessions; Conventional home or ambulatory tDCS for 9 weeks with 42 total sessions
Duration - Up to 3 months after treatment completion
Participants are monitored for safety and effectiveness of treatment after the end of the stimulation sessions.
Follow-up visits scheduled at 3 months post-treatment
Trial Site Locations
Total: 3 locations
1
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08304
Actively Recruiting
2
Hospital Universitari de Mataró
Mataró, Barcelona, Spain, 08304
Actively Recruiting
3
Parc Taulí Hospital Universitari
Sabadell, Barcelona, Spain, 08208
Not Yet Recruiting
Research Team
A
Ane Miren Gutiérrez Muto, PhD
E
Ensayos Ionclincs
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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