Fibromyalgia (FM)FM-TDCS-PREDICNCT07583056
EEG Prediction and Clinical Efficacy of tDCS in Fibromyalgia.
A study testing High-dose home-tDCS M1, Conventional home-tDCS and High-dose home-tDCS DLPFC in people with Fibromyalgia (FM), run by Ionclinics & Deionic SL at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia (FM)
- What is being tested?
- High-dose home-tDCS M1, Conventional home-tDCS and High-dose home-tDCS DLPFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jul 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia
Ionclinics, +34674059324, ensayos@ionclinics.com
About this study
Official title: 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.
- Conditions
- Fibromyalgia (FM)
- Being tested
- High-dose home-tDCS M1, Conventional home-tDCS, High-dose home-tDCS DLPFC
- Keywords
- tDCS, Fibromyalgia, EEG, Cost-effectiveness
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose home-tDCS M1Device
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-tDCSDevice
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 DLPFCDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| High-dose home-tDCS M1 | Experimental | tDCS administered at home using a high-dose protocol targeting the primary motor cortex. Receives: Device: High-dose home-tDCS M1 |
| Conventional home-tDCS | Active comparator | tDCS administered at home using a conventional stimulation protocol targeting the primary motor cortex. Receives: Device: Conventional home-tDCS |
| High-Dose home-tDCS DLPFC | Experimental | tDCS administered at home using a high-dose stimulation protocol targeting the dorsolateral prefrontal cortex. Receives: Device: High-dose home-tDCS DLPFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire
Changes from baseline to the end of the treatment in the revised version of Fibromyalgia Impact Questionnaire (FIQ-R).
Measured: Baseline and end of treatment (week 3 for experimental; week 4 for active comparator).
Secondary outcomes (8)
WPI
Change from baseline to end of treatment in Widespread Pain Inventory (WPI).
Measured: Baseline; end of treatment (3 week experimental; 4 week active comparator)
SSS
Change from baseline to end of treatment in Symptom Severity Scale (SSS).
Measured: Baseline; end of treatment (3 week experimental; 4 week active comparator)
HADS
Change from baseline to end of treatment in Hospital Anxiety and Depression Scale (HADS).
Measured: Baseline; end of treatment (3 week experimental; 4 week active comparator).
PSQI
Change from baseline to end of treatment in Pittsburgh Sleep Quality Index (PSQI).
Measured: Baseline; end of treatment (3 week experimental; 4 week active comparator).
EQ-5D
Change from baseline to end of treatment in EuroQoL-5D (EQ-5D).
Measured: Baseline; end of treatment (3 week experimental; 4 week active comparator).
PGI-C
Change at the end of treatment in Patient Global Impression of Change (PGI-C).
Measured: End of treatment (3 week experimental; 4 week active comparator).
BDI-II
Changes from baseline to end of treatment in Beck Depression Inventory-II.
Measured: Baseline and end of treatment (week 3 for experimental; week 4 for active comparator).
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start8 Jul 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, parallel-group, controlled clinical trial with blinded evaluators, which prospectively and systematically includes a cost-effectiveness analysis and an assessment of the predictive value of electroencephalographic biomarkers. Randomization will be performed after baseline measurement, with a 3:1 allocation ratio (High-dose home-tDCS M1 : conventional home-tDCS) using randomized blocks (between 4 and 8). The randomization will account for the inclusion of a third independent group (High-dose home-tDCS DLPFC), with the sample size for this third treatment arm adjusted accordingly.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ionclinics & Deionic SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Clínico Universitario de Valencia
- Responsible party
- Sponsor
- Investigators
- 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583056
- Sponsor's protocol ID
- ION002_EEG_TDCS_FM
- Acronym
- FM-TDCS-PREDIC
- Status last verified
- Jul 2026
- First submitted
- 30 Apr 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of tDCS in Fibromyalgia: A Controlled Clinical Trial and Analysis of Electrophysiological Biomarker Predictors.
- ClinicalTrials.gov ID
- NCT07583056
- Acronym / sponsor ID
- FM-TDCS-PREDIC / ION002_EEG_TDCS_FM
- Conditions
- Fibromyalgia (FM)
- Keywords
- tDCS, Fibromyalgia, EEG, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ionclinics & Deionic SLIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Clínico Universitario de Valencia
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized, parallel-group, controlled clinical trial with blinded evaluators, which prospectively and systematically includes a cost-effectiveness analysis and an assessment of the predictive value of electroencephalographic biomarkers. Randomization will be performed after baseline measurement, with a 3:1 allocation ratio (High-dose home-tDCS M1 : conventional home-tDCS) using randomized blocks (between 4 and 8). The randomization will account for the inclusion of a third independent group (High-dose home-tDCS DLPFC), with the sample size for this third treatment arm adjusted accordingly.
| Arm | Type | Receives |
|---|---|---|
| High-dose home-tDCS M1 | Experimental | Device: High-dose home-tDCS M1tDCS administered at home using a high-dose protocol targeting the primary motor cortex. |
| Conventional home-tDCS | Active comparator | Device: Conventional home-tDCStDCS administered at home using a conventional stimulation protocol targeting the primary motor cortex. |
| High-Dose home-tDCS DLPFC | Experimental | Device: High-dose home-tDCS DLPFCtDCS administered at home using a high-dose stimulation protocol targeting the dorsolateral prefrontal cortex. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose home-tDCS M1Transcranial 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). | Device | High-dose home-tDCS M1 |
| Conventional home-tDCSTranscranial 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). | Device | Conventional home-tDCS |
| High-dose home-tDCS DLPFCTranscranial 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). | Device | High-Dose home-tDCS DLPFC |
Primary outcome
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).
8 secondary outcomes
WPI
Time frame: Baseline; end of treatment (3 week experimental; 4 week active comparator)
SSS
Time frame: Baseline; end of treatment (3 week experimental; 4 week active comparator)
HADS
Time frame: Baseline; end of treatment (3 week experimental; 4 week active comparator).
PSQI
Time frame: Baseline; end of treatment (3 week experimental; 4 week active comparator).
EQ-5D
Time frame: Baseline; end of treatment (3 week experimental; 4 week active comparator).
PGI-C
Time frame: End of treatment (3 week experimental; 4 week active comparator).
BDI-II
Time frame: Baseline and end of treatment (week 3 for experimental; week 4 for active comparator).
Resting state EEG
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: 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.
Related trials for Fibromyalgia (FM)
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Recruiting
Feasibility and Effects of Noninvasive Brain Stimulation on Pain Perception in People With Fibromyalgia
Fibromyalgia (FM)
Not yet recruiting
Feasibility and Preliminary Effects of an Asynchronous Microlearning Intervention on Fibromyalgia Knowledge Among Primary Health Care Workers
Fibromyalgia, Fibromyalgia (FM)
Not yet recruiting
Multisite Transcutaneous Electrical Nerve Stimulation in Fibromyalgia: A Randomized, Double-Blind, Sham-Controlled Crossover Trial Comparing Two Stimulation Modalities
Fibromyalgia, Fibromyalgia (FM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-dose home-tDCS M1, Conventional home-tDCS and High-dose home-tDCS DLPFC in people with Fibromyalgia (FM), run by Ionclinics & Deionic SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ane Miren Gutiérrez Muto, PhD (+34960606200, investigacion@ionclinics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire (time frame: Baseline and end of treatment (week 3 for experimental; week 4 for active comparator).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.