EEG Prediction and Clinical Efficacy of tDCS in Major Depression (DM-TDCS-PREDIC)
3 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
270
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Ane Miren Gutiérrez Muto, PhD
- Numéro de téléphone: +34960606200
- E-mail: investigacion@ionclinics.com
Sauvegarde des contacts de l'étude
- Nom: Ensayos Ionclinics
- Numéro de téléphone: +34674059324
- E-mail: ensayos@ionclinics.com
Lieux d'étude
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-
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Valencia, Espagne
- Recrutement
- Hospital Universiatrio Doctor Peset
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Contact:
- Ionclinics
- Numéro de téléphone: +34674059324
- E-mail: ensayos@ionclinics.com
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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).
|
|
Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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HDRS-17
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
MDRS
Délai: 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).
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Baseline; end of treatment (3 week experimental; 10 week active comparator).
|
|
C-SSRS
Délai: 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)
|
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HAM-A
Délai: 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
Délai: 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).
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Baseline; end of treatment (3 week experimental; 10 week active comparator)
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RAVLT
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Attentes des patients
Délai: Valeur de base
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Échelle de Likert de 1 à 5 (où 1 correspond à aucune attente et 5 à l'attente la plus élevée possible) pour étudier l'influence de l'attente sur l'effet du traitement.
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Valeur de base
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Incremental Cost Effectiveness Ratio
Délai: 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
Délai: 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
Délai: 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.
|
Through study completion, an average of 2 years.
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MINI
Délai: 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
Délai: 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
Délai: 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
Délai: 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
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Ane Miren Gutiérrez Muto, PhD, Ionclinics & Deionics S.L.
- Chaise d'étude: Mar Hernández Secorún, PhD, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
- Chaise d'étude: Gustavo Sarriá Córdoba, MSc, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
14 juin 2026
Achèvement primaire (Estimé)
30 juin 2028
Achèvement de l'étude (Estimé)
31 décembre 2028
Dates d'inscription aux études
Première soumission
7 mai 2026
Première soumission répondant aux critères de contrôle qualité
20 mai 2026
Première publication (Réel)
28 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ION001_EEG_TDCS_TDM
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .