EEG Prediction and Clinical Efficacy of tDCS in Fibromyalgia. (FM-TDCS-PREDIC)
13 de julio de 2026 actualizado por: Ionclinics & Deionic SL
Clinical Efficacy of tDCS in Fibromyalgia: 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 fibromyalgia.
As complementary goals, we aim to assess the predictive value of baseline EEG for clinical response to high-dose home-based tDCS treatment; and to describe the effectiveness of a high-dose home-based protocol applied to the motor cortex (M1) versus the dorsolateral prefrontal cortex (DLFPC) in patients with fibromyalgia.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
250
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 Ionclincs
- Número de teléfono: +34674059324
- Correo electrónico: ensayos@ionclinics.com
Ubicaciones de estudio
-
-
-
Valencia, España
- Reclutamiento
- Hospital Clínico Universitario de Valencia
-
Contacto:
- Ionclinics
- Número de teléfono: +34674059324
- Correo electrónico: ensayos@ionclinics.com
-
-
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 who meet the diagnostic criteria described by the American College of Rheumatology (Wolfe et al., 2016):
- Widespread Pain Index (WPI) ≥7 and Symptom Severity Scale (SSS) score ≥5 or a WPI score of 4-6 and SSS ≥9
- Presence of widespread pain, defined as pain in at least 4 of 5 regions. Jaw, chest, and abdominal pain are not included in the definition of widespread pain.
- Symptoms have been generally present for at least 3 months.
- The diagnosis of fibromyalgia (FM) is valid regardless of other diagnoses. The diagnosis of FM does not exclude the presence of other clinically significant diseases.
- Patients with a stable prescription (or lack thereof) for antidepressant/pharmacological medication and who agree to continue it throughout the study.
- Demonstrate the ability to properly administer home-based tDCS independently or with the assistance of a caregiver.
- Have access to an electronic device with a camera (mobile phone or computer) to allow for monitoring of the intervention and communication with the participant.
- Have the capacity and willingness to commit to the study team for the completion of all phases of the study.
- Volunteer to participate and sign the specific informed consent form for this study.
Exclusion Criteria:
- Presenting with immune system disorders or comorbidities that explain the main symptoms of fibromyalgia: rheumatoid arthritis, lupus, autoimmune, neurological, and oncological disorders.
- Presenting with any uncompensated clinical condition such as ischemic heart disease, kidney disease, or liver disease.
- Presenting with dermatological conditions, such as allergic skin reactions at the electrode sites, psoriasis, etc.
- Any exclusion criteria established by clinical guidelines on non-invasive brain stimulation (Woods et al., 2016):
- Metallic implants or head injuries, any electronic device such as cochlear implants or cardiac pacemakers.
- Brain stimulation within the last 6 months.
- A clinical or family history of epilepsy.
- Having any structural lesion (for example, 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 could affect safety, participation in the study, or confound the interpretation of the study results, as determined by the investigator.
- History of drug or alcohol abuse during the study or in the 3 months prior (except for nicotine).
- Changes in drug treatment in the month prior to starting the trial.
- Awaiting trial or litigation during 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 |
|---|---|
|
Experimental: High-dose home-tDCS M1
tDCS administered at home using a high-dose protocol targeting the primary motor cortex.
|
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 C3 (primary motor cortex) and the cathode to Fp2 (contralateral anterior frontal 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). |
|
Comparador activo: Conventional home-tDCS
tDCS administered at home using a conventional stimulation protocol targeting the primary motor cortex.
|
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 C3 (primary motor cortex) and the cathode to Fp2 (contralateral anterior frontal region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation. Dose: 4 weeks, from Monday to Friday. 1 time per day (total of 20 sessions). |
|
Experimental: High-Dose home-tDCS DLPFC
tDCS administered at home using a high-dose stimulation protocol targeting the dorsolateral prefrontal cortex.
|
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 cortex) and the cathode to F8 (right ventrolateral prefrontal cortex). 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). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fibromyalgia Impact Questionnaire
Periodo de tiempo: Baseline and end of treatment (week 3 for experimental; week 4 for active comparator).
|
Changes from baseline to the end of the treatment in the revised version of Fibromyalgia Impact Questionnaire (FIQ-R).
|
Baseline and end of treatment (week 3 for experimental; week 4 for active comparator).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
WPI
Periodo de tiempo: Baseline; end of treatment (3 week experimental; 4 week active comparator)
|
Change from baseline to end of treatment in Widespread Pain Inventory (WPI).
|
Baseline; end of treatment (3 week experimental; 4 week active comparator)
|
|
SSS
Periodo de tiempo: Baseline; end of treatment (3 week experimental; 4 week active comparator)
|
Change from baseline to end of treatment in Symptom Severity Scale (SSS).
|
Baseline; end of treatment (3 week experimental; 4 week active comparator)
|
|
HADS
Periodo de tiempo: Baseline; end of treatment (3 week experimental; 4 week active comparator).
|
Change from baseline to end of treatment in Hospital Anxiety and Depression Scale (HADS).
|
Baseline; end of treatment (3 week experimental; 4 week active comparator).
|
|
PSQI
Periodo de tiempo: Baseline; end of treatment (3 week experimental; 4 week active comparator).
|
Change from baseline to end of treatment in Pittsburgh Sleep Quality Index (PSQI).
|
Baseline; end of treatment (3 week experimental; 4 week active comparator).
|
|
EQ-5D
Periodo de tiempo: Baseline; end of treatment (3 week experimental; 4 week active comparator).
|
Change from baseline to end of treatment in EuroQoL-5D (EQ-5D).
|
Baseline; end of treatment (3 week experimental; 4 week active comparator).
|
|
PGI-C
Periodo de tiempo: End of treatment (3 week experimental; 4 week active comparator).
|
Change at the end of treatment in Patient Global Impression of Change (PGI-C).
|
End of treatment (3 week experimental; 4 week active comparator).
|
|
BDI-II
Periodo de tiempo: Baseline and end of treatment (week 3 for experimental; week 4 for active comparator).
|
Changes from baseline to end of treatment in Beck Depression Inventory-II.
|
Baseline and end of treatment (week 3 for experimental; week 4 for active comparator).
|
|
Resting state EEG
Periodo de tiempo: Baseline
|
32-channel active-electrode EEG (impedances <5 kΩ) recordings in open and close eye conditions.
The spectral density and spectral power of delta, theta, alpha, beta, and gamma will be analyzed, as well as the topographic distribution.
|
Baseline
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Expectativas del Paciente
Periodo de tiempo: Línea base
|
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.
|
Línea base
|
|
Responders to tDCS
Periodo de tiempo: Through study completion, an average of 2 years.
|
A subject is considered a responder if: - Improvement of 50% or more in FIQ-R from baseline to immediate post-treatment. |
Through study completion, an average of 2 years.
|
|
Adverse Effect
Periodo de tiempo: End-of-day application (Experimental: 7 days per week through 3 weeks; Active Comparator: 5 days per week, through 4 weeks).
|
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: 5 days per week, through 4 weeks).
|
|
Success of blinding
Periodo de tiempo: 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
|
|
Incremental Cost Effectiveness Ratio
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
|
NRS
Periodo de tiempo: Each day during the treatment (21 days for experimental; 28 days for active comparator).
|
Daily report of the numeric rating scale for symptom intensity, ranging from 0 to 10 (with 0 meaning 'none' and 10 meaning 'the worst imaginable').
|
Each day during the treatment (21 days for experimental; 28 days for active comparator).
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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)
8 de julio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
30 de junio de 2028
Fechas de registro del estudio
Enviado por primera vez
30 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de mayo de 2026
Publicado por primera vez (Actual)
13 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 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
- ION002_EEG_TDCS_FM
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. .