EEG Prediction and Clinical Efficacy of tDCS in Major Depression (DM-TDCS-PREDIC)
3 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
270
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ane Miren Gutiérrez Muto, PhD
- Número de teléfono: +34960606200
- Correo electrónico: investigacion@ionclinics.com
Copia de seguridad de contactos de estudio
- Nombre: Ensayos Ionclinics
- Número de teléfono: +34674059324
- Correo electrónico: ensayos@ionclinics.com
Ubicaciones de estudio
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Valencia, España
- Reclutamiento
- Hospital Universiatrio Doctor Peset
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Contacto:
- Ionclinics
- Número de teléfono: +34674059324
- Correo electrónico: ensayos@ionclinics.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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HDRS-17
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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MDRS
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Expectativas del Paciente
Periodo de tiempo: Línea base
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Escala Likert del 1 al 5 (donde 1 es ninguna expectativa y 5 es la máxima expectativa posible) para estudiar la influencia de la expectativa en el efecto del tratamiento.
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Línea base
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Incremental Cost Effectiveness Ratio
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Ane Miren Gutiérrez Muto, PhD, Ionclinics & Deionics S.L.
- Silla de estudio: Mar Hernández Secorún, PhD, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
- Silla de estudio: Gustavo Sarriá Córdoba, MSc, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
14 de junio de 2026
Finalización primaria (Estimado)
30 de junio de 2028
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
7 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de mayo de 2026
Publicado por primera vez (Actual)
28 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ION001_EEG_TDCS_TDM
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .