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NCT Number: NCT07583056

EEG Prediction and Clinical Efficacy of tDCS in Fibromyalgia.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universitario de Valencia

Valencia, Spain

Location status: Recruiting

Location contact

Ionclinics

CONTACT

[email protected]

+34674059324

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-dose home-tDCS M1

Device

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).

Conventional home-tDCS

Device

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).

High-dose home-tDCS DLPFC

Device

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).

Primary outcomes

  1. Fibromyalgia Impact Questionnaire

    Time frame: 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).

Secondary outcomes

  1. WPI

    Time frame: Baseline; end of treatment (3 week experimental; 4 week active comparator)

    Change from baseline to end of treatment in Widespread Pain Inventory (WPI).

  2. SSS

    Time frame: Baseline; end of treatment (3 week experimental; 4 week active comparator)

    Change from baseline to end of treatment in Symptom Severity Scale (SSS).

  3. HADS

    Time frame: 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).

  4. PSQI

    Time frame: Baseline; end of treatment (3 week experimental; 4 week active comparator).

    Change from baseline to end of treatment in Pittsburgh Sleep Quality Index (PSQI).

  5. EQ-5D

    Time frame: Baseline; end of treatment (3 week experimental; 4 week active comparator).

    Change from baseline to end of treatment in EuroQoL-5D (EQ-5D).

  6. PGI-C

    Time frame: End of treatment (3 week experimental; 4 week active comparator).

    Change at the end of treatment in Patient Global Impression of Change (PGI-C).

  7. BDI-II

    Time frame: 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.

  8. Resting state EEG

    Time frame: 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.

Other outcomes

  1. Responders to tDCS

    Time frame: 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.
  2. Adverse Effect

    Time frame: 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.

  3. Success of blinding

    Time frame: 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.

  4. Patient Expectations

    Time frame: Baseline

    Likert scale from 1 to 5 (where 1 is no expectation and 5 is the highest possible expectation) to study the influence of expectation on the effect of treatment.

  5. Incremental Cost Effectiveness Ratio

    Time frame: Through study completion, an average of 2 years.

    Incremental Cost Effectiveness Ratio (ICER) will be derived from clinical effectiveness, utility and costs.

  6. Costs

    Time frame: Through study completion, an average of 2 years.

    Direct and indirect medical and non-medical costs will be collected for the cost-effectiveness analysis.

  7. Utility

    Time frame: 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.

  8. NRS

    Time frame: 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').

Study contacts

Contact information is provided by the study sponsor or research team.

Ane Miren Gutiérrez Muto, PhD

CONTACT

[email protected]

+34960606200

Ensayos Ionclincs

CONTACT

[email protected]

+34674059324

Sponsors and collaborators

Lead sponsor

Ionclinics & Deionic SL

Industry

Collaborators

  • Hospital Clínico Universitario de Valencia

Registry information

Official study title

Clinical Efficacy of tDCS in Fibromyalgia: A Controlled Clinical Trial and Analysis of Electrophysiological Biomarker Predictors.

Acronym: FM-TDCS-PREDIC

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 13, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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