EEG Prediction and Clinical Efficacy of tDCS in Fibromyalgia.

Official title

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

Overview

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.

Interventions

• Device High-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;
• Device Conventional 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).
• Device High-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

Primary outcome measures

• Fibromyalgia Impact Questionnaire [Time frame: Baseline and end of treatment (week 3 for experimental; week 4 for active comparator).]

Secondary outcome measures (8)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Hospital Clínico Universitario de Valencia — Valencia

Identifiers

NCT: NCT07583056 · ION002_EEG_TDCS_FM

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗