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EEG Prediction and Clinical Efficacy of tDCS in Fibromyalgia. (FM-TDCS-PREDIC)

13. juli 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

250

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Spanien
      • Valencia, Spanien
        • Rekruttering
        • Hospital Clínico Universitario de Valencia
        • Kontakt:

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 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

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
Eksperimentel: High-dose home-tDCS M1
tDCS administered at home using a high-dose protocol targeting the primary motor cortex.
Enhed: High-dose home-tDCS M1

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).
Aktiv komparator: Conventional home-tDCS
tDCS administered at home using a conventional stimulation protocol targeting the primary motor cortex.
Enhed: Conventional home-tDCS

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).
Eksperimentel: High-Dose home-tDCS DLPFC
tDCS administered at home using a high-dose stimulation protocol targeting the dorsolateral prefrontal cortex.
Enhed: High-dose home-tDCS DLPFC

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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fibromyalgia Impact Questionnaire
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
WPI
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patientforventninger
Tidsramme: Baseline
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.
Baseline
Responders to tDCS
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ionclinics & Deionic SL

Samarbejdspartnere

Hospital Clínico Universitario de Valencia

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)

8. juli 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

30. juni 2028

Datoer for studieregistrering

Først indsendt

30. april 2026

Først indsendt, der opfyldte QC-kriterier

7. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ION002_EEG_TDCS_FM

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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