Fibromyalgia (FM)
Conditions
Keywords
tDCS, Fibromyalgia, EEG, Cost-effectiveness
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.
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).
Sponsors
Ionclinics & Deionic SL
Hospital Clínico Universitario de Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fibromyalgia Impact Questionnaire | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WPI | Baseline; end of treatment (3 week experimental; 4 week active comparator) | Change from baseline to end of treatment in Widespread Pain Inventory (WPI). |
| SSS | Baseline; end of treatment (3 week experimental; 4 week active comparator) | Change from baseline to end of treatment in Symptom Severity Scale (SSS). |
| HADS | Baseline; end of treatment (3 week experimental; 4 week active comparator). | Change from baseline to end of treatment in Hospital Anxiety and Depression Scale (HADS). |
| PSQI | Baseline; end of treatment (3 week experimental; 4 week active comparator). | Change from baseline to end of treatment in Pittsburgh Sleep Quality Index (PSQI). |
| EQ-5D | Baseline; end of treatment (3 week experimental; 4 week active comparator). | Change from baseline to end of treatment in EuroQoL-5D (EQ-5D). |
| PGI-C | End of treatment (3 week experimental; 4 week active comparator). | Change at the end of treatment in Patient Global Impression of Change (PGI-C). |
| BDI-II | Baseline and end of treatment (week 3 for experimental; week 4 for active comparator). | Changes from baseline to end of treatment in Beck Depression Inventory-II. |
| Resting state EEG | Baseline | 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. |
Countries
Spain
Contacts
CONTACTAne Miren Gutiérrez Muto, PhD
CONTACTEnsayos Ionclincs
STUDY_DIRECTORAne Miren Gutiérrez Muto, PhD
Ionclinics & Deionics S.L.
STUDY_CHAIRMar Hernández Secorún, PhD
Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
STUDY_CHAIRGustavo Sarriá Córdoba, MSc
Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
Outcome results
None listed