EEG Prediction and Clinical Efficacy of tDCS in Fibromyalgia. (FM-TDCS-PREDIC)
13 de julho de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
250
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Ane Miren Gutiérrez Muto, PhD
- Número de telefone: +34960606200
- E-mail: investigacion@ionclinics.com
Estude backup de contato
- Nome: Ensayos Ionclincs
- Número de telefone: +34674059324
- E-mail: ensayos@ionclinics.com
Locais de estudo
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-
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Valencia, Espanha
- Recrutamento
- Hospital Clínico Universitario de Valencia
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Contato:
- Ionclinics
- Número de telefone: +34674059324
- E-mail: ensayos@ionclinics.com
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Ativo: 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). |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fibromyalgia Impact Questionnaire
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
WPI
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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).
|
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EQ-5D
Prazo: 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).
|
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PGI-C
Prazo: 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
Prazo: 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).
|
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Resting state EEG
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Expectativas do Paciente
Prazo: Linha de Base
|
Escala de Likert de 1 a 5 (onde 1 significa nenhuma expectativa e 5 significa a maior expectativa possível) para estudar a influência da expectativa no efeito do tratamento.
|
Linha de Base
|
|
Responders to tDCS
Prazo: 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.
|
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Adverse Effect
Prazo: 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).
|
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Success of blinding
Prazo: 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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Incremental Cost Effectiveness Ratio
Prazo: 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
Prazo: 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.
|
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Utility
Prazo: 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.
|
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NRS
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Ane Miren Gutiérrez Muto, PhD, Ionclinics & Deionics S.L.
- Cadeira de estudo: Mar Hernández Secorún, PhD, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
- Cadeira de estudo: Gustavo Sarriá Córdoba, MSc, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
8 de julho de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
30 de junho de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
30 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de maio de 2026
Primeira postagem (Real)
13 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
15 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ION002_EEG_TDCS_FM
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .