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

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Centre Forum (Parc de Salut Mar)
RECRUITING
Barcelona
Contact Information
Primary
Alicia Valiente Gómez, M.D.
avaliente@researchmar.net
(0034)933268500
Backup
Benedikt L. Amann, M.D.
62517@parcdesalutmar.cat
(0034)933268500
Time Frame
Start Date: 2025-01-21
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 96
Treatments
Active_comparator: EMDR plus tDCS
tDCS stimulation will consist of 2mA tDCS for 20 minutes applied immediately before EMDR sessions.
Placebo_comparator: EMDR plus sham-tDCS
Sham stimulation will consist of inactive tDCS for 20 minutes applied immediately before EMDR sessions
No_intervention: Treatment as Usual
Patients in this condition will not receive EMDR nor tDCS sessions, and will continue to attend their regular visits with rheumatology and psychiatry.
Sponsors
Collaborators: Universitat Oberta de Catalunya
Leads: Parc de Salut Mar

This content was sourced from clinicaltrials.gov

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