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EEG Prediction and Clinical Efficacy of tDCS in Major Depression (DM-TDCS-PREDIC)

3 juli 2026 bijgewerkt door: Ionclinics & Deionic SL

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

270

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Spanje
      • Valencia, Spanje
        • Werving
        • Hospital Universiatrio Doctor Peset
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: High-dose home-tDCS
Apparaat: High-dose home-tDCS
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).
Actieve vergelijker: Conventional home-tDCS
Apparaat: Conventional home-tDCS
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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
HDRS-17
Tijdsspanne: 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).
Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
MDRS
Tijdsspanne: Baseline; end of treatment (3 week experimental; 10 week active comparator).
Changes from baseline to the end of treatment in the Montgomery-Åsberg Depression Rating Scale (MDRS).
Baseline; end of treatment (3 week experimental; 10 week active comparator).
C-SSRS
Tijdsspanne: Baseline; end of treatment (3 week experimental; 10 week active comparator)
Changes from baseline to the end of treatment in the Columbia Suicide Severity Rating Scale (C-SSRS).
Baseline; end of treatment (3 week experimental; 10 week active comparator)
HAM-A
Tijdsspanne: Baseline; end of treatment (3 week experimental; 10 week active comparator)
Changes from baseline to the end of treatment in the Hamilton Anxiety Rating Scale (HAM-A).
Baseline; end of treatment (3 week experimental; 10 week active comparator)
YMRS
Tijdsspanne: Baseline; end of treatment (3 week experimental; 10 week active comparator)
Changes from baseline to the end of treatment in the Young Mania Rating Scale (YMRS).
Baseline; end of treatment (3 week experimental; 10 week active comparator)
RAVLT
Tijdsspanne: Baseline; end of treatment (3 week experimental; 10 week active comparator)
Changes from baseline to the end of treatment in the Rey-Auditory Verbal Learning Test (RAVLT).
Baseline; end of treatment (3 week experimental; 10 week active comparator)
SDMT
Tijdsspanne: Baseline; end of treatment (3 week experimental; 10 week active comparator).
Changes from baseline to the end of treatment in the Symbol Digit Modalities Test (SDMT).
Baseline; end of treatment (3 week experimental; 10 week active comparator).
Bristol stool scale
Tijdsspanne: Baseline; end of treatment (3 week experimental; 10 week active comparator).
Changes from baseline to the end of treatment in the Bristol Stool Scale.
Baseline; end of treatment (3 week experimental; 10 week active comparator).
Mediterranean Diet Questionnaire
Tijdsspanne: Baseline
Diet habits of the patients assessed with the Mediterranean diet questionnaire.
Baseline
Meal frequency
Tijdsspanne: Baseline
Meal frequency intake of patients prior to the starting of the project.
Baseline
EQ-5D
Tijdsspanne: Baseline; end of treatment (3 week experimental; 10 week active comparator).
Changes from baseline to the end of treatment in the EuroQoL-5D questionnaire (EQ-5D).
Baseline; end of treatment (3 week experimental; 10 week active comparator).
PGI-C
Tijdsspanne: End of treatment (3 week experimental; 10 week active comparator)
Changes of impression at the end of treatment assess with the Patient Global Impression of Change (PGI-C).
End of treatment (3 week experimental; 10 week active comparator)
Resting state EEG
Tijdsspanne: Baseline
32-channel active-electrode EEG (impedances <5 kΩ) recordings in open and close eye conditions.
Baseline
Stool samples
Tijdsspanne: Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).
Changes in stool sample biomarkers from baseline to end of treatment.
Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Verwachtingen van de patiënt
Tijdsspanne: Baseline
Likertschaal van 1 tot 5 (waarbij 1 geen verwachting is en 5 de hoogst mogelijke verwachting) om de invloed van verwachting op het effect van behandeling te bestuderen.
Baseline
Incremental Cost Effectiveness Ratio
Tijdsspanne: Through study completion, an average of 2 years.
Incremental Cost Effectiveness Ratio (ICER) will be derived from clinical effectiveness, utility and costs.
Through study completion, an average of 2 years.
Costs
Tijdsspanne: Through study completion, an average of 2 years.
Direct and indirect medical and non-medical costs will be collected for the cost-effectiveness analysis.
Through study completion, an average of 2 years.
Utility
Tijdsspanne: Through study completion, an average of 2 years.
Quality-adjusted life years (QALYs) will be calculated using the EQ-5D questionnaire for the cost-effectiveness analysis.
Through study completion, an average of 2 years.
MINI
Tijdsspanne: Baseline
Score of items "Psychotic Disorder" in the MINI International. Neuropsychiatric Interview for selection criteria.
Baseline
Responders to tDCS
Tijdsspanne: Through study completion, an average of 2 years.
A subject is considered a responder if: - Improvement of 50% or more in HDRS-17 or MADRS from baseline to immediate post-treatment.
Through study completion, an average of 2 years.
Adverse Effect
Tijdsspanne: End-of-day application (Experimental: 7 days per week through 3 weeks; Active Comparator: From week 1 to 3, 5 days per week; From week 4 to 10, 3 days per week).
A daily questionnaire about adverse effects will be completed at the end of the last intervention of the day.
End-of-day application (Experimental: 7 days per week through 3 weeks; Active Comparator: From week 1 to 3, 5 days per week; From week 4 to 10, 3 days per week).
Successful blinding
Tijdsspanne: Through study completion, an average of 2 years
A method 3 x 3 will be used to evaluate the success of the study's evaluator and statistician.
Through study completion, an average of 2 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ionclinics & Deionic SL

Medewerkers

Hospital Universitario Doctor Peset
Universidad Europea de Valencia

Onderzoekers

  • Studie directeur: Ane Miren Gutiérrez Muto, PhD, Ionclinics & Deionics S.L.
  • Studie stoel: Mar Hernández Secorún, PhD, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
  • Studie stoel: Gustavo Sarriá Córdoba, MSc, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 juni 2026

Primaire voltooiing (Geschat)

30 juni 2028

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

7 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

20 mei 2026

Eerst geplaatst (Werkelijk)

28 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

3 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ION001_EEG_TDCS_TDM

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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