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NOT YET RECRUITING
NCT07583056
NA

EEG Prediction and Clinical Efficacy of tDCS in Fibromyalgia.

Sponsor: Ionclinics & Deionic SL

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2026-05-15

Completion Date

2028-06-30

Last Updated

2026-05-13

Healthy Volunteers

No

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; (3) 3rd week - 1 time per day (total of 42 sessions).

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 times per day; (3) 3rd week - 1 time per day (total of 42 sessions).

Locations (1)

Hospital Clínico Universitario de Valencia

Valencia, Spain