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

13. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

250

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: High-dose home-tDCS M1
tDCS administered at home using a high-dose protocol targeting the primary motor cortex.
Gerät: 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).
Aktiver Komparator: Conventional home-tDCS
tDCS administered at home using a conventional stimulation protocol targeting the primary motor cortex.
Gerät: 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).
Experimental: High-Dose home-tDCS DLPFC
tDCS administered at home using a high-dose stimulation protocol targeting the dorsolateral prefrontal cortex.
Gerät: 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).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Fibromyalgia Impact Questionnaire
Zeitfenster: 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).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
WPI
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Patientenerwartungen
Zeitfenster: Ausgangswert
Likert-Skala von 1 bis 5 (wobei 1 keine Erwartung und 5 die höchstmögliche Erwartung ist), um den Einfluss der Erwartung auf die Wirkung der Behandlung zu untersuchen.
Ausgangswert
Responders to tDCS
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ionclinics & Deionic SL

Mitarbeiter

Hospital Clínico Universitario de Valencia

Ermittler

  • Studienleiter: Ane Miren Gutiérrez Muto, PhD, Ionclinics & Deionics S.L.
  • Studienstuhl: Mar Hernández Secorún, PhD, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
  • Studienstuhl: Gustavo Sarriá Córdoba, MSc, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

8. Juli 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2027

Studienabschluss (Geschätzt)

30. Juni 2028

Studienanmeldedaten

Zuerst eingereicht

30. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Mai 2026

Zuerst gepostet (Tatsächlich)

13. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ION002_EEG_TDCS_FM

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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