EEG Prediction and Clinical Efficacy of tDCS in Fibromyalgia.

ConditionFibromyalgia (FM)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorIonclinics & Deionic SL

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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).

Treatment groups

250 Participants

are divided into 3 treatment groups

Group A: High-dose home-tDCS M1Experimental treatment 1 intervention

Group B: Conventional home-tDCSActive comparator 1 intervention

Group C: High-Dose home-tDCS DLPFCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

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)

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)

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).

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).

Other outcomes

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.

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).

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ionclinics & Deionic SL

Lead sponsor

Hospital Clínico Universitario de Valencia

Collaborator

Source ClinicalTrials.gov

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