EEG Prediction and Clinical Efficacy of tDCS in Major Depression

NCT07611773 | Not Yet Recruiting

• 1 other identifier: ION001_EEG_TDCS_TDM
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

tDCS; Major depression; EEG; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• HDRS-17

  Changes from baseline to the end of the treatment in the 17-items Hamilton Depression Rating Scale (HDRS-17).

  Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).

Secondary Outcomes (13)

• MDRS

  Baseline; end of treatment (3 week experimental; 10 week active comparator).

• C-SSRS

  Baseline; end of treatment (3 week experimental; 10 week active comparator)

• HAM-A

  Baseline; end of treatment (3 week experimental; 10 week active comparator)

• YMRS

  Baseline; end of treatment (3 week experimental; 10 week active comparator)

• RAVLT

  Baseline; end of treatment (3 week experimental; 10 week active comparator)

Other Outcomes (8)

• MINI

  Baseline

• Responders to tDCS

  Through study completion, an average of 2 years.

• Incremental Cost Effectiveness Ratio

  Through study completion, an average of 2 years.

Study Arms (2)

High-dose home-tDCS

EXPERIMENTAL

Device: High-dose home-tDCS

Conventional home-tDCS

ACTIVE COMPARATOR

Device: Conventional home-tDCS

Interventions

High-dose home-tDCS DEVICE

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).

High-dose home-tDCS

Conventional home-tDCS DEVICE

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).

Conventional home-tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or over.
• Patients diagnosed with Major Depressive Disorder with a current depressive episode, based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (American Psychiatric Association, 2013).
• Score on the Hamilton Depression Rating Scale (HDRS-17) ≥16 (Hamilton et al., 1960).
• Patients on a stable prescription of antidepressants/pharmacological medication and who agree to continue this throughout the study; and/or, if undergoing psychotherapy, who have maintained this treatment consistently for at least 6 weeks.
• Demonstrate the ability to apply home-based tDCS appropriately, either independently or with the help of a carer.
• Have access to an electronic device with a camera to enable monitoring of the intervention, as well as to contact the participant.
• Have the ability and willingness to commit to the study team to complete all phases of the study.
• Volunteer to participate and sign the specific informed consent form for this study.

You may not qualify if:

• Patients with a current manic episode as determined by the Young Mania Rating Scale (YMRS), or a psychotic episode as defined by the MINI scale.
• Patients who answer 'yes' to questions 4, 5 or 6 of the Columbia Suicide Severity Rating Scale (C-SSRS), a risk assessment and identification tool.
• Patients with treatment-resistant depression, defined as an inadequate clinical response to two or more courses of antidepressant treatment at appropriate doses and duration.
• Any previous hospitalisation for suicidal behaviour.
• Presenting with current chronic or severe insomnia (\< 4 hours' sleep per night) or sleep apnoea.
• Presence of any structural lesion (e.g., any structural neurological condition or more subcortical lesions than would be expected for their age, or having suffered a stroke affecting the stimulated area or connected areas) or any other clinically significant abnormality that may affect safety, participation in the study, or confound the interpretation of study results, as determined by the investigator.
• History or presence of any other condition or comorbidity associated with TDM: cardiac or neurological conditions, cognitive impairment.
• History of or current diagnosis of any other mental disorder: obsessive-compulsive disorder, bipolar disorder (type 1 or 2), anxiety disorder, agoraphobia, eating disorders, personality disorders.
• Metal implants or head injuries, any electronic devices such as cochlear implants or cardiac pacemakers
• Brain stimulation within the last 6 months.
• Clinical or family history of epilepsy or seizure episodes.
• Presence of dermatological problems (allergic skin reaction at the electrode site, psoriasis, etc.)
• History of drug or alcohol abuse during the study or in the 3 months prior (with the exception of nicotine).
• Pending trial or litigation during the course of the trial.
• Pregnancy.

Sponsors & Collaborators

• Ionclinics & Deionic SL: lead
• Hospital Universitario Doctor Peset: collaborator
• Universidad Europea de Valencia: collaborator

Study Sites (1)

Hospital Universiatrio Doctor Peset

Valencia, Spain

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ane Miren Gutiérrez Muto, PhD

  Ionclinics & Deionics S.L.

  STUDY DIRECTOR

• Mar Hernández Secorún, PhD

  Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.

  STUDY CHAIR

• Gustavo Sarriá Córdoba, MSc

  Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.

  STUDY CHAIR

Central Study Contacts

Ane Miren Gutiérrez Muto, PhD

CONTACT

+34960606200; investigacion@ionclinics.com

Ensayos Ionclinics

CONTACT

+34674059324; ensayos@ionclinics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: EEG analyst will be blinded from group treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)