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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
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).
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).
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).
Hospital Clínico Universitario de Valencia
Valencia, Spain
RECRUITINGFibromyalgia 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).
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).
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).
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).
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).
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
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