ClinicalTrials.gg
RecruitingNCT07583056FM-TDCS-PREDICUpdated Jul 15, 2026

EEG Prediction and Clinical Efficacy of tDCS in Fibromyalgia.

An interventional study of High-dose home-tDCS M1 and Conventional home-tDCS in Fibromyalgia (FM), sponsored by Ionclinics & Deionic SL. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by Ionclinics & Deionic SL · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 151 studies in Fibromyalgia with a site in Spain — 16 open to participants now, 21 under way, none of them phase 3. Fibromyalgia · Spain.

Planned enrollment
15th of 135
250 · median 66
Started
2026
with 5 others
No phase
113 of 151
14 open now
Primary completion
2027-12
later than 20 of 20 live
Registered
147th of 151
by date

Among the 151 studies in Fibromyalgia with a site in Spain, this one is the 15th largest by planned enrollment of the 135 interventional ones that give a count, is one of 6 that started in 2026, is one of 113 with no phase, reaches primary completion later than 20 of the 20 other live ones, and was the 147th registered.

Fibromyalgia

1,244 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.

Browse Fibromyalgia studies →

Open to participants now

16 of the 151 studies in Fibromyalgia with a site in Spain are open now. Recruiting first, the newest first:

10 more — sign in →

All 16 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 161 Fibromyalgia studies recruiting now, 50 (31%) set no upper age limit and 97 (60%) stop at 75 or younger; 15 take children under 18; 35 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 151 studies in Fibromyalgia with a site in Spain, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Fibromyalgia (FM)

Browse trials for

Keywords

  • tDCS
  • Fibromyalgia
  • EEG
  • Cost-effectiveness
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 form for this study.

Exclusion criteria

Exclusion Criteria:

  • Presenting with immune system disorders or comorbidities that explain the main symptoms of fibromyalgia: rheumatoid arthritis, lupus, , 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 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    High-dose home-tDCS M1

    tDCS administered at home using a high-dose protocol targeting the primary motor cortex.

    Device: High-dose home-tDCS M1

  • Active comparator
    Conventional home-tDCS

    tDCS administered at home using a conventional stimulation protocol targeting the primary motor cortex.

    Device: Conventional home-tDCS

  • Experimental
    High-Dose home-tDCS DLPFC

    tDCS administered at home using a high-dose stimulation protocol targeting the dorsolateral prefrontal cortex.

    Device: High-dose home-tDCS DLPFC

Interventions

  • DeviceHigh-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).

  • DeviceConventional 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).

  • DeviceHigh-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).

06

What researchers measure

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).

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

Secondary outcomes

  1. WPI

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

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

  2. SSS

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

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

  3. HADS

    Change from baseline to end of treatment in Hospital Anxiety and Depression Scale (HADS).

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

  4. PSQI

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

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

  5. EQ-5D

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

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

  6. PGI-C

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

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

  7. BDI-II

    Changes from baseline to end of treatment in Beck Depression Inventory-II.

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

  8. Resting state EEG

    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.

    Time frame: Baseline

Other outcomes

  1. Responders to tDCS

    A subject is considered a responder if: \- Improvement of 50% or more in FIQ-R from baseline to immediate post-treatment.

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

  2. Adverse Effect

    A daily questionnaire about adverse effects will be completed at the end of the last intervention of the day.

    Time frame: End-of-day application (Experimental: 7 days per week through 3 weeks; Active Comparator: 5 days per week, through 4 weeks).

  3. Success of blinding

    A method 3 x 3 will be used to evaluate the success of the study's evaluator and statistician.

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

  4. Patient Expectations

    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.

    Time frame: Baseline

  5. Incremental Cost Effectiveness Ratio

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

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

  6. Costs

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

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

  7. Utility

    Quality-adjusted life years (QALYs) will be calculated using the EQ-5D questionnaire for the cost-effectiveness analysis.

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

  8. NRS

    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').

    Time frame: Each day during the treatment (21 days for experimental; 28 days for active comparator).

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Dec 2027, 17 months after the start.

Of 451 interventional studies with no phase under Fibromyalgia, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 30. This study's planned 17 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2026
First posted
May 13, 2026
StartActual
Jul 8, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Jun 30, 2028
Last update
Jul 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07583056
Lead sponsor
Ionclinics & Deionic SL
Collaborators
Hospital Clínico Universitario de Valencia
Responsible party
Sponsor
First posted
May 13, 2026
Start date
Jul 8, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Jul 15, 2026

Study contacts

Ane Miren Gutiérrez Muto, PhD
Contact
investigacion@ionclinics.com
+34960606200
Ensayos Ionclincs
Contact
ensayos@ionclinics.com
+34674059324
Ane Miren Gutiérrez Muto, PhD
study director · Ionclinics & Deionics S.L.
Mar Hernández Secorún, PhD
study chair · Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
Gustavo Sarriá Córdoba, MSc
study chair · Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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