Augmentation of EMDR With Transcranial Direct Current Stimulation (tDCS) in the Treatment of Fibromyalgia: a Double-blind Randomized Controlled Trial

What this Trial Is About

Fibromyalgia (FM) is a chronic condition causing widespread pain and affects 2-4% of the general population. It often comes with sleep problems, memory and attention issues, anxiety, and depression. Current drug and psychological treatments often have limited success. Because FM is linked to psychological trauma affecting stress responses, this research evaluates trauma-focused psychotherapy combined with brain stimulation as a new treatment option for women with FM. The trial compares three groups of female participants diagnosed with FM: one receiving Eye Movement Desensitization and Reprocessing (EMDR) therapy plus active transcranial Direct Current Stimulation (tDCS), another receiving EMDR plus sham (inactive) tDCS, and a third group receiving treatment as usual (TAU) without these interventions. EMDR involves 20 weekly one-hour sessions using a standardized protocol, while tDCS is delivered as 2mA brain stimulation for 20 minutes immediately before each EMDR session. The sham group receives inactive tDCS, and the TAU group continues regular care without these treatments. Participants will be evaluated at the start, after 6 months post-treatment, and at a 12-month follow-up. Assessments include measuring pain intensity, physical function, trauma symptoms, anxiety, depression, fatigue, and wellbeing using various clinical scales. The study also monitors cognitive function, emotion regulation, self-care, and sleep quality. Therapists, patients, and outcome raters will not know which tDCS treatment is given to ensure unbiased results. The total participation lasts up to one year with several in-person assessments.

Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia