Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Fibromyalgia, Psychological Trauma, Depressive Symptoms, Anxiety

In brief

Fibromyalgia (FM) is a generalized, widespread chronic pain disorder and has an estimated prevalence of 2%-4% in the general population. Current pharmacological and psychological interventions frequently produce limited benefits in FM patients. Due to FM's strong association with psychological trauma causing neurobiological alterations in stress response, a trauma-focused psychotherapy is an innovative alternative treatment option. Eye Movement Desensitization and Reprocessing (EMDR) has been recognized by the World Health Organization as a first-line therapeutic tool for post-traumatic stress disorder and first evidence suggests that it is also beneficial for patients with FM. Given the complex etiology of FM, a combination of psychotherapy with other treatment options can maximize a potential therapeutic success. A possible candidate herby is transcranial Direct Current Stimulation (tDCS), a non-invasive stimulation technique, which can modify neural activities related to pain and which has shown short-term positive effects on chronic pain and quality of life in FM patients. The patient sample will consist of 96 female patients meeting 2016 American College of Rheumatology criteria for FM based on a clinical interview. They will be randomized to 20 sessions of EMDR plus tDCS or EMDR plus sham-tDCS, or Treatment as Usual (TAU). Therapists, raters, and patients will be kept blind to tDCS treatment conditions. Evaluations will be at baseline, post treatment at 6 months, and follow-up at 12 months. Hypotheses are that EMDR improves pain intensity and clinical symptoms at short and long-term, and that tDCS enhances this effect, which will be superior to tDCS-sham.

Key facts

Study ID

NCT04084795

Run by

Parc de Salut Mar

People needed

96

Starts

2025-01-21

Expected to finish

2026-12-31

Last updated by the study team

2025-08-03

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age between 18 and 70 years old
• Mean pain score of at least 4 on the visual analog scale (VAS) in the two weeks preceding the clinical trial
• Presence of one or more traumatic events causing current trauma-related symptoms
• Current clinical symptoms of depression and/or anxiety
• 2 weeks of stable medication

You may not qualify if…

• Comorbid autoimmune or chronic inflammatory disease
• Neurological or serious medical diseases
• Bipolar disorder, schizoaffective disorder and schizophrenia
• Suicidal ideation
• Previous EMDR therapy in the past two years
• Substance abuse/dependency within 1 month prior to participation (except for nicotine abuse/dependency),
• Pending FM-related litigation or disability
• Metallic implants in the head
• Positive test for pregnancy
• Skin sensitivity diseases (psoriasis, eczema, dermatitis, etc.)

Where it is running

• Centre Forum (Parc de Salut Mar) — Barcelona, Catalonia, Spain (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.