Study of High-Dose Versus Conventional Home-Based tDCS Treatment for Fibromyalgia Evaluating Effectiveness and EEG Biomarkers to Predict Response

What this Trial Is About

Researchers are investigating the use of transcranial direct current stimulation tDCS, a non-invasive brain stimulation method, in patients with fibromyalgia. This trial aims to compare a high-dose home-based tDCS protocol with a conventional home-based protocol to see if the high-dose option is not worse and possibly better. Additionally, the study will explore whether baseline EEG can predict how well patients respond to the high-dose treatment and compare stimulation targeting two brain areas the primary motor cortex and the dorsolateral prefrontal cortex. Participants will receive tDCS at home using one of three protocols a high-dose targeting the primary motor cortex, a conventional dose targeting the same area, or a high-dose targeting the dorsolateral prefrontal cortex. Each session lasts 20 minutes. The high-dose protocols last 3 weeks with varying daily frequencies 3 timesday in week 1, 2 timesday in week 2, and onceday in week 3, totaling 42 sessions. The conventional protocol lasts 4 weeks with one daily session Monday to Friday, totaling 20 sessions. During the study, participants will be assessed at baseline and at the end of their treatment period week 3 for high-dose groups, week 4 for conventional. Assessments include questionnaires on fibromyalgia impact, pain, symptom severity, anxiety, sleep quality, quality of life, depression, and patient global impression of change. Baseline resting state EEG is also collected. The study will monitor adherence via electronic devices with cameras and require participants to continue stable medication regimens. The total participation time corresponds to the treatment duration plus assessments.

EEG Prediction and Clinical Efficacy of tDCS in Fibromyalgia.