Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
FEMALE
NCT04084795

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

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Centre Forum (Parc de Salut Mar)

Barcelona, Catalonia, Spain, 08019

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here