EEG Prediction and Clinical Efficacy of tDCS in Major Depression (DM-TDCS-PREDIC)
3. juli 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
270
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ane Miren Gutiérrez Muto, PhD
- Telefonnummer: +34960606200
- E-mail: investigacion@ionclinics.com
Undersøgelse Kontakt Backup
- Navn: Ensayos Ionclinics
- Telefonnummer: +34674059324
- E-mail: ensayos@ionclinics.com
Studiesteder
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-
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Valencia, Spanien
- Rekruttering
- Hospital Universiatrio Doctor Peset
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Kontakt:
- Ionclinics
- Telefonnummer: +34674059324
- E-mail: ensayos@ionclinics.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: High-dose home-tDCS
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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).
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Aktiv komparator: Conventional home-tDCS
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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).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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HDRS-17
Tidsramme: Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).
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Changes from baseline to the end of the treatment in the 17-items Hamilton Depression Rating Scale (HDRS-17).
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Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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MDRS
Tidsramme: Baseline; end of treatment (3 week experimental; 10 week active comparator).
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Changes from baseline to the end of treatment in the Montgomery-Åsberg Depression Rating Scale (MDRS).
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Baseline; end of treatment (3 week experimental; 10 week active comparator).
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C-SSRS
Tidsramme: Baseline; end of treatment (3 week experimental; 10 week active comparator)
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Changes from baseline to the end of treatment in the Columbia Suicide Severity Rating Scale (C-SSRS).
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Baseline; end of treatment (3 week experimental; 10 week active comparator)
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HAM-A
Tidsramme: Baseline; end of treatment (3 week experimental; 10 week active comparator)
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Changes from baseline to the end of treatment in the Hamilton Anxiety Rating Scale (HAM-A).
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Baseline; end of treatment (3 week experimental; 10 week active comparator)
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YMRS
Tidsramme: Baseline; end of treatment (3 week experimental; 10 week active comparator)
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Changes from baseline to the end of treatment in the Young Mania Rating Scale (YMRS).
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Baseline; end of treatment (3 week experimental; 10 week active comparator)
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RAVLT
Tidsramme: Baseline; end of treatment (3 week experimental; 10 week active comparator)
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Changes from baseline to the end of treatment in the Rey-Auditory Verbal Learning Test (RAVLT).
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Baseline; end of treatment (3 week experimental; 10 week active comparator)
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SDMT
Tidsramme: Baseline; end of treatment (3 week experimental; 10 week active comparator).
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Changes from baseline to the end of treatment in the Symbol Digit Modalities Test (SDMT).
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Baseline; end of treatment (3 week experimental; 10 week active comparator).
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Bristol stool scale
Tidsramme: Baseline; end of treatment (3 week experimental; 10 week active comparator).
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Changes from baseline to the end of treatment in the Bristol Stool Scale.
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Baseline; end of treatment (3 week experimental; 10 week active comparator).
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Mediterranean Diet Questionnaire
Tidsramme: Baseline
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Diet habits of the patients assessed with the Mediterranean diet questionnaire.
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Baseline
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Meal frequency
Tidsramme: Baseline
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Meal frequency intake of patients prior to the starting of the project.
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Baseline
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EQ-5D
Tidsramme: Baseline; end of treatment (3 week experimental; 10 week active comparator).
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Changes from baseline to the end of treatment in the EuroQoL-5D questionnaire (EQ-5D).
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Baseline; end of treatment (3 week experimental; 10 week active comparator).
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PGI-C
Tidsramme: End of treatment (3 week experimental; 10 week active comparator)
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Changes of impression at the end of treatment assess with the Patient Global Impression of Change (PGI-C).
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End of treatment (3 week experimental; 10 week active comparator)
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Resting state EEG
Tidsramme: Baseline
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32-channel active-electrode EEG (impedances <5 kΩ) recordings in open and close eye conditions.
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Baseline
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Stool samples
Tidsramme: Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).
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Changes in stool sample biomarkers from baseline to end of treatment.
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Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Patientforventninger
Tidsramme: Baseline
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Likert-skala fra 1 til 5 (hvor 1 er ingen forventning og 5 er den højst mulige forventning) til at undersøge indflydelsen af forventning på behandlingens effekt.
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Baseline
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Incremental Cost Effectiveness Ratio
Tidsramme: Through study completion, an average of 2 years.
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Incremental Cost Effectiveness Ratio (ICER) will be derived from clinical effectiveness, utility and costs.
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Through study completion, an average of 2 years.
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Costs
Tidsramme: Through study completion, an average of 2 years.
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Direct and indirect medical and non-medical costs will be collected for the cost-effectiveness analysis.
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Through study completion, an average of 2 years.
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Utility
Tidsramme: Through study completion, an average of 2 years.
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Quality-adjusted life years (QALYs) will be calculated using the EQ-5D questionnaire for the cost-effectiveness analysis.
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Through study completion, an average of 2 years.
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MINI
Tidsramme: Baseline
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Score of items "Psychotic Disorder" in the MINI International.
Neuropsychiatric Interview for selection criteria.
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Baseline
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Responders to tDCS
Tidsramme: Through study completion, an average of 2 years.
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A subject is considered a responder if: - Improvement of 50% or more in HDRS-17 or MADRS from baseline to immediate post-treatment.
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Through study completion, an average of 2 years.
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Adverse Effect
Tidsramme: 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).
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A daily questionnaire about adverse effects will be completed at the end of the last intervention of the day.
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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).
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Successful blinding
Tidsramme: Through study completion, an average of 2 years
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A method 3 x 3 will be used to evaluate the success of the study's evaluator and statistician.
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Through study completion, an average of 2 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Ane Miren Gutiérrez Muto, PhD, Ionclinics & Deionics S.L.
- Studiestol: Mar Hernández Secorún, PhD, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
- Studiestol: Gustavo Sarriá Córdoba, MSc, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. juni 2026
Primær færdiggørelse (Anslået)
30. juni 2028
Studieafslutning (Anslået)
31. december 2028
Datoer for studieregistrering
Først indsendt
7. maj 2026
Først indsendt, der opfyldte QC-kriterier
20. maj 2026
Først opslået (Faktiske)
28. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ION001_EEG_TDCS_TDM
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
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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