EEG Prediction and Clinical Efficacy of tDCS in Fibromyalgia.
FM-TDCS-PREDIC
Clinical Efficacy of tDCS in Fibromyalgia: A Controlled Clinical Trial and Analysis of Electrophysiological Biomarker Predictors.
1 other identifier
interventional
250
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2026
CompletedFirst Posted
Study publicly available on registry
May 13, 2026
CompletedStudy Start
First participant enrolled
May 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
May 13, 2026
May 1, 2026
1.6 years
April 30, 2026
May 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fibromyalgia Impact Questionnaire
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).
Secondary Outcomes (8)
WPI
Baseline; end of treatment (3 week experimental; 4 week active comparator)
SSS
Baseline; end of treatment (3 week experimental; 4 week active comparator)
HADS
Baseline; end of treatment (3 week experimental; 4 week active comparator).
PSQI
Baseline; end of treatment (3 week experimental; 4 week active comparator).
EQ-5D
Baseline; end of treatment (3 week experimental; 4 week active comparator).
- +3 more secondary outcomes
Other Outcomes (7)
Responders to tDCS
Through study completion, an average of 2 years.
Adverse Effect
End-of-day application (Experimental: 7 days per week through 3 weeks; Active Comparator: 5 days per week, through 4 weeks).
Success of blinding
Through study completion, an average of 2 years
- +4 more other outcomes
Study Arms (3)
High-dose home-tDCS M1
EXPERIMENTALtDCS administered at home using a high-dose protocol targeting the primary motor cortex.
Conventional home-tDCS
ACTIVE COMPARATORtDCS administered at home using a conventional stimulation protocol targeting the primary motor cortex.
High-Dose home-tDCS DLPFC
EXPERIMENTALtDCS administered at home using a high-dose stimulation protocol targeting the dorsolateral prefrontal cortex.
Interventions
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).
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).
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clínico Universitario de Valencia
Valencia, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ane Miren Gutiérrez Muto, PhD
Ionclinics & Deionics S.L.
- STUDY CHAIR
Mar Hernández Secorún, PhD
Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
- STUDY CHAIR
Gustavo Sarriá Córdoba, MSc
Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2026
First Posted
May 13, 2026
Study Start
May 15, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
May 13, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
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.