NCT04084795

Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia

Recruiting now NA Last updated 3 August 2025

What this trial tests

NA trial testing Eye Movement Desensitization and Reprocessing therapy in Fibromyalgia in 96 participants. Currently enrolling.

Timeline

21 January 2025

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Parc de Salut Mar
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	96
Start date	21 January 2025
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across Spain

Drugs / interventions tested

• Eye Movement Desensitization and Reprocessing therapy
• transcranial Direct Current Stimulation

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →
• Psychological Trauma — all drugs for Psychological Trauma →
• Depressive Symptoms — all drugs for Depressive Symptoms →
• Anxiety — all drugs for Anxiety →

Sponsor

Parc de Salut Mar — full company profile →

Who can join

Adults 18 to 70, female only, with Fibromyalgia or Psychological Trauma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Augmentation of EMDR with multifocal transcranial current stimulation (MtCS) in the treatment of fibromyalgia: study protocol of a double-blind randomized controlled exploratory and pragmatic trial.
   Gardoki-Souto I, Martín de la Torre O, Hogg B, Redolar-Ripoll D, et al · · 2021 · cited 4× · PMID 33514408 · DOI 10.1186/s13063-021-05042-w
2. The study protocol of a double-blind randomized controlled trial of EMDR and multifocal transcranial current stimulation (MtCS) as augmentation strategy in patients with fibromyalgia.
   Gardoki-Souto I, Martín de la Torre O, Hogg B, Redolar-Ripoll D, et al · · 2024 · PMID 39741323 · DOI 10.1186/s13063-024-08708-3
3. ºCorrigendum: Augmentation of EMDR with Multifocal transcranial Current Stimulation (MtCS) in the treatment of fibromyalgia: study protocol of a double blind randomized controlled exploratory and pragmatic trial.
   Gardoki-Souto I, Torre OMdl, Hogg B, Redolar-Ripoll D, et al · · 2024 · DOI 10.21203/rs.3.rs-4363105/v1