Hospital Clínico Universitario de Valencia
Valencia, Spain
Location status: Recruiting
NCT Number: NCT07583056
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Valencia, Spain
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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).
Time frame: Baseline; end of treatment (3 week experimental; 4 week active comparator)
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)
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).
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).
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).
Change from baseline to end of treatment in EuroQoL-5D (EQ-5D).
Time frame: End of treatment (3 week experimental; 4 week active comparator).
Change at the end of treatment in Patient Global Impression of Change (PGI-C).
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 2 years.
A subject is considered a responder if:
Time frame: End-of-day application (Experimental: 7 days per week through 3 weeks; Active Comparator: 5 days per week, through 4 weeks).
A daily questionnaire about adverse effects will be completed at the end of the last intervention of the day.
Time frame: Through study completion, an average of 2 years
A method 3 x 3 will be used to evaluate the success of the study's evaluator and statistician.
Time frame: Baseline
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: Through study completion, an average of 2 years.
Incremental Cost Effectiveness Ratio (ICER) will be derived from clinical effectiveness, utility and costs.
Time frame: Through study completion, an average of 2 years.
Direct and indirect medical and non-medical costs will be collected for the cost-effectiveness analysis.
Time frame: Through study completion, an average of 2 years.
Quality-adjusted life years (QALYs) will be calculated using the EQ-5D questionnaire for the cost-effectiveness analysis.
Time frame: Each day during the treatment (21 days for experimental; 28 days for active comparator).
Daily report of the numeric rating scale for symptom intensity, ranging from 0 to 10 (with 0 meaning 'none' and 10 meaning 'the worst imaginable').
Contact information is provided by the study sponsor or research team.
Ane Miren Gutiérrez Muto, PhD
CONTACT
Ensayos Ionclincs
CONTACT
Ionclinics & Deionic SL
Industry
Clinical Efficacy of tDCS in Fibromyalgia: A Controlled Clinical Trial and Analysis of Electrophysiological Biomarker Predictors.
Acronym: FM-TDCS-PREDIC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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