Depression - Major Depressive DisorderDM-TDCS-PREDICNCT07611773
EEG Prediction and Clinical Efficacy of tDCS in Major Depression
A study testing High-dose home-tDCS and Conventional home-tDCS in people with Depression - Major Depressive Disorder, run by Ionclinics & Deionic SL at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- High-dose home-tDCS and Conventional home-tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jun 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Any exclusion criteria other than those 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 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universiatrio Doctor Peset
Valencia
Ionclinics, +34674059324, ensayos@ionclinics.com
About this study
Official title: Clinical Efficacy of tDCS in Major Depression: A Controlled Clinical Trial and Analysis of Electrophysiological Biomarker Predictors
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
- Being tested
- High-dose home-tDCS, Conventional home-tDCS
- Keywords
- tDCS, Major depression, EEG, Cost-effectiveness
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose home-tDCSDevice
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).
Conventional home-tDCSDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| High-dose home-tDCS | Experimental | Not described Receives: Device: High-dose home-tDCS |
| Conventional home-tDCS | Active comparator | Not described Receives: Device: Conventional home-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDRS-17
Changes from baseline to the end of the treatment in the 17-items Hamilton Depression Rating Scale (HDRS-17).
Measured: Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).
Secondary outcomes (13)
MDRS
Changes from baseline to the end of treatment in the Montgomery-Åsberg Depression Rating Scale (MDRS).
Measured: Baseline; end of treatment (3 week experimental; 10 week active comparator).
C-SSRS
Changes from baseline to the end of treatment in the Columbia Suicide Severity Rating Scale (C-SSRS).
Measured: Baseline; end of treatment (3 week experimental; 10 week active comparator)
HAM-A
Changes from baseline to the end of treatment in the Hamilton Anxiety Rating Scale (HAM-A).
Measured: Baseline; end of treatment (3 week experimental; 10 week active comparator)
YMRS
Changes from baseline to the end of treatment in the Young Mania Rating Scale (YMRS).
Measured: Baseline; end of treatment (3 week experimental; 10 week active comparator)
RAVLT
Changes from baseline to the end of treatment in the Rey-Auditory Verbal Learning Test (RAVLT).
Measured: Baseline; end of treatment (3 week experimental; 10 week active comparator)
SDMT
Changes from baseline to the end of treatment in the Symbol Digit Modalities Test (SDMT).
Measured: Baseline; end of treatment (3 week experimental; 10 week active comparator).
Bristol stool scale
Changes from baseline to the end of treatment in the Bristol Stool Scale.
Measured: Baseline; end of treatment (3 week experimental; 10 week active comparator).
Mediterranean Diet Questionnaire
Diet habits of the patients assessed with the Mediterranean diet questionnaire.
Measured: Baseline
Meal frequency
Meal frequency intake of patients prior to the starting of the project.
Measured: Baseline
EQ-5D
Changes from baseline to the end of treatment in the EuroQoL-5D questionnaire (EQ-5D).
Measured: Baseline; end of treatment (3 week experimental; 10 week active comparator).
PGI-C
Changes of impression at the end of treatment assess with the Patient Global Impression of Change (PGI-C).
Measured: End of treatment (3 week experimental; 10 week active comparator)
Resting state EEG
32-channel active-electrode EEG (impedances <5 kΩ) recordings in open and close eye conditions.
Measured: Baseline
Stool samples
Changes in stool sample biomarkers from baseline to end of treatment.
Measured: Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start14 Jun 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ionclinics & Deionic SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Doctor Peset, Universidad Europea de Valencia
- Responsible party
- Sponsor
- Investigators
- Ane Miren Gutiérrez Muto, PhD, Study director, Ionclinics & Deionics S.L.Mar Hernández Secorún, PhD, Study chair, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.Gustavo Sarriá Córdoba, MSc, Study chair, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611773
- Sponsor's protocol ID
- ION001_EEG_TDCS_TDM
- Acronym
- DM-TDCS-PREDIC
- Status last verified
- Jul 2026
- First submitted
- 7 May 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of tDCS in Major Depression: A Controlled Clinical Trial and Analysis of Electrophysiological Biomarker Predictors
- ClinicalTrials.gov ID
- NCT07611773
- Acronym / sponsor ID
- DM-TDCS-PREDIC / ION001_EEG_TDCS_TDM
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- tDCS, Major depression, EEG, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Ionclinics & Deionic SLIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Doctor Peset, Universidad Europea de Valencia
- Study start
- 14 Jun 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dose home-tDCS | Experimental | Device: High-dose home-tDCS |
| Conventional home-tDCS | Active comparator | Device: Conventional home-tDCS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose home-tDCSTranscranial 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). | Device | High-dose home-tDCS |
| Conventional home-tDCSTranscranial 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). | Device | Conventional home-tDCS |
Primary outcome
HDRS-17
Time frame: Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).
Changes from baseline to the end of the treatment in the 17-items Hamilton Depression Rating Scale (HDRS-17).
13 secondary outcomes
MDRS
Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator).
C-SSRS
Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator)
HAM-A
Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator)
YMRS
Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator)
RAVLT
Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator)
SDMT
Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator).
Bristol stool scale
Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator).
Mediterranean Diet Questionnaire
Time frame: Baseline
Meal frequency
Time frame: Baseline
EQ-5D
Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator).
PGI-C
Time frame: End of treatment (3 week experimental; 10 week active comparator)
Resting state EEG
Time frame: Baseline
Stool samples
Time frame: Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ane Miren Gutiérrez Muto, PhD study director
Ionclinics & Deionics S.L.
Mar Hernández Secorún, PhD study chair
Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
Gustavo Sarriá Córdoba, MSc study chair
Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-dose home-tDCS and Conventional home-tDCS in people with Depression - Major Depressive Disorder, run by Ionclinics & Deionic SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ane Miren Gutiérrez Muto, PhD (+34960606200, investigacion@ionclinics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HDRS-17 (time frame: Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.