# PROTOCOL STUDY OF A RANDOMISED CONTROLLED TRIAL TO EVALUATE THE INCREASED EFFICACY OF EMDR WITH TRANSCRANIAL DIRECT CURRENT STIMULATION (MTDCS) IN THE TREATMENT OF FIBROMYALGIA

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- Page title: PROTOCOL STUDY OF A RANDOMISED CONTROLLED TRIAL TO EVALUATE THE INCREASED EFFICACY OF EMDR WITH TRANSCRANIAL DIRECT CURRENT STIMULATION (MTDCS) IN THE TREATMENT OF FIBROMYALGIA | Assoc. Prof. Dr. Alişan Burak Yaşar

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# PROTOCOL STUDY OF A RANDOMISED CONTROLLED TRIAL TO EVALUATE THE INCREASED EFFICACY OF EMDR WITH TRANSCRANIAL DIRECT CURRENT STIMULATION (MTDCS) IN THE TREATMENT OF FIBROMYALGIA

July 30, 2024EMDR Europe Symposium 2024 Posters

PROTOCOL STUDY OF A RANDOMISED CONTROLLED TRIAL TO EVALUATE THE INCREASED EFFICACY OF EMDR WITH TRANSCRANIAL DIRECT CURRENT STIMULATION (MTDCS) IN THE TREATMENT OF FIBROMYALGIA. (PROTOCOL STUDY OF A RANDOMISED CONTROLLED TRIAL TO EVALUATE THE INCREASED EFFICACY OF EMDR WITH TRANSCRANIAL DIRECT CURRENT STIMULATION (MTDCS) IN THE TREATMENT OF FIBROMYALGIA.)

MARTA FONTANA-MCNALLY, ANA MORENO-ALCÁZAR, BRIDGET HOGG, WALTER LUPO, BENEDIKT L. AMANN AND ALICIA VALIENTE-GÓMEZ.

Translated by: Specialist Psychologist Gizem Pozam

Background and Aims

Fibromyalgia (FM) is a widespread chronic pain disorder affecting 2.4% of the Spanish population. It is currently conceptualized as a disorder involving sensitization of the central nervous system (CNS) and impairments in endogenous pain inhibitory mechanisms, with genetic, hormonal, and immunological factors playing a role. In recent years, various studies have observed a strong association with psychological trauma, with PTSD being a frequent comorbidity in patients with FM.

Given the complex etiology of FM, combining psychotherapy with other treatment options may increase effectiveness and maximize therapeutic success. Therefore, combining a trauma-focused psychotherapy, such as eye movement desensitization and reprocessing (EMDR), with a non-invasive brain stimulation technique, such as multifocal transcranial direct current stimulation (MtDCS), may be an innovative adjunctive treatment option that maximizes therapeutic potential.

Methods

This project proposes a double-blind randomized controlled clinical trial involving 96 female patients with FM who have a history of traumatic events. Patients will be randomly assigned to the following groups: treatment as usual (TAU) versus TAU + EMDR + MtDCS-active versus TAU + EMDR + MtDCS-sham (inactive). All patients will be assessed at baseline, after treatment, and at a follow-up 6 months after the post-treatment assessment. Assessments will include the following clinical and functional variables: sociodemographic data, pain assessment, fatigue, psychological trauma, sleep disturbance, anxiety, affective symptoms, and well-being.

Results and Conclusions

This poster presents the first protocol for a double-blind RCT investigating whether EMDR is effective in treating FM and its comorbid symptoms, and whether its potential is enhanced by the addition of MCS. As this is a protocol, no results from this study are available yet; however, we believe this study will provide evidence as to whether EMDR therapy is effective in reducing pain symptoms in patients with FM and whether the effect of EMDR can be enhanced by MtDCS.

PROTOCOL STUDY OF A RANDOMISED CONTROLLED TRIAL TO EVALUATE THE INCREASED EFFICACY OF EMDR WITH TRANSCRANIAL DIRECT CURRENT STIMULATION (MTDCS) IN THE TREATMENT OF FIBROMYALGIA.

MARTA FONTANA-MCNALLY, ANA MORENO-ALCÁZAR, BRIDGET HOGG, WALTER LUPO, BENEDIKT L. AMANN AND ALICIA VALIENTE-GÓMEZ.

Background and Aims

Fibromyalgia (FM) is a generalized, widespread chronic pain disorder affecting 2.4% of the Spanish population. It is currently conceptualized as a disorder involving the sensitization of the central nervous system (CNS) and impairments in endogenous pain inhibitory mechanisms, with genetics, hormonal, and immunological factors playing a role. In the last years, different studies have observed a strong association with psychological trauma and PTSD is a frequent comorbidity in patients suffering from FM.

Given the complex etiology of FM, combining psychotherapy with other treatment options might increase the effectiveness and maximize therapeutic success. Therefore, a trauma-focused psychotherapy. such as eye movement desensitization and reprocessing (EMDR), combined with a non-invasive brain stimulation technique, such as, Multifocal transcranial Direct Current Stimulation (MtDCS) could be an innovative adjunctive treatment option, maximizing therapeutic potential.

Methods

This project proposes a double-blinded randomized control trail clinical trial including 96 female patients with FM with a history of traumatic events. The patients will be randomly allocated to: treatment as usual (TAU) versus TAU + EMDR + MtDCS-active versus TAU + EMDR + MtDCS-sham (inactive). All patients will be evaluated at baseline, post-treatment and a follow-up at 6 months after post-treatment evaluation. Evaluations will include the following clinical and functional variables: sociodemographic data, evaluation of pain, fatigue, psychological trauma, sleep disturbance, anxiety, affective symptoms, and wellbeing.

RESULTS & CONCLUSIONS

This poster presents the first protocol of a double blind RCT to investigate whether EMDR is effective in the treatment of FM and its comorbid symptoms, and if its potential is boosted with the addition of MCS. As it is a protocol, there are no results from this study yet; however, we think this study will provide evidence of whether EMDR therapy is effective in reducing pain symptoms in FM patients, and whether the effect of EMDR can be enhanced by MtDCS.

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