Actively Recruiting
Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia
Led by Parc de Salut Mar · Updated on 2025-08-03
96
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
Sponsors
P
Parc de Salut Mar
Lead Sponsor
U
Universitat Oberta de Catalunya
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old
- Mean pain score of at least 4 on the visual analog scale (VAS) in the two weeks before the trial
- Experienced one or more traumatic events causing current trauma-related symptoms
- Current clinical symptoms of depression and/or anxiety
- Stable medication for at least 2 weeks before the trial
You will not qualify if you...
- Having autoimmune or chronic inflammatory diseases
- Having neurological or serious medical diseases
- Diagnosis of bipolar disorder, schizoaffective disorder, or schizophrenia
- Suicidal thoughts
- Previous EMDR therapy within the past two years
- Substance abuse or dependency within 1 month before participation (except nicotine)
- Pending fibromyalgia-related litigation or disability claims
- Metal implants in the head
- Positive pregnancy test
- Skin sensitivity diseases such as psoriasis, eczema, or dermatitis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centre Forum (Parc de Salut Mar)
Barcelona, Catalonia, Spain, 08019
Actively Recruiting
Research Team
A
Alicia Valiente Gómez, M.D.
CONTACT
B
Benedikt L. Amann, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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