RecruitingNot ApplicableNCT04084795

Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia

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


Sponsor

Parc de Salut Mar

Enrollment

96 participants

Start Date

Jan 21, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a mild form of brain stimulation (called tDCS — which uses a small electrical current applied to the scalp) can improve the results of EMDR therapy for people with fibromyalgia. EMDR is a type of therapy originally developed for trauma that may also help with chronic pain. **You may be eligible if...** - You are between 18 and 70 years old - You have fibromyalgia with a pain score of at least 4 out of 10 - You have experienced one or more traumatic events that are still affecting you - You have current symptoms of depression or anxiety - Your medications have been stable for at least 2 weeks **You may NOT be eligible if...** - You have an autoimmune or chronic inflammatory condition - You have a serious neurological illness - You have bipolar disorder, schizoaffective disorder, or schizophrenia - You have thoughts of suicide - You have received EMDR therapy in the past 2 years - You have metal implants in your head - You are pregnant - You have skin conditions like psoriasis or eczema Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALEye Movement Desensitization and Reprocessing therapy

EMDR is a psychotherapeutic approach using a standardized 8-phase protocol to alleviate the distress associated with traumatic memories, facilitating the access to and processing of traumatic memories. Patients will receive 20 individual EMDR sessions of 60 minutes each using the standard protocol, as well as a specific pain protocol and the fibromyalgia protocol. EMDR is an integrative psychotherapy that uses standardized protocols and elements of cognitive-behavioral, interpersonal, and body-centered therapies, as well as dual stimulation (e.g., side-to-side eye movements). The current standard protocol includes eight phases: Patient history. Patient preparation. Patient assessment. Memory desensitization. Installing the positive cognition. Body scan. Closure. Reevaluation.

OTHERtranscranial Direct Current Stimulation

tDCS represents a promising intervention option, given its capacity to modulate cerebral excitability in a simple, safe manner. F3 anodal; Fp1, F7, Fc5, AF3, Fc1, Fz, return montage will be used with the anode over the left DLPFC. Half of the patients will receive active stimulation and the other half sham stimulation. Active stimulation will consist of 2mA tDCS for 20 minutes applied immediately before EMDR sessions. The same protocol and montage will be used for sham stimulation.


Locations(1)

Centre Forum (Parc de Salut Mar)

Barcelona, Catalonia, Spain

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NCT04084795


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