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Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Active, Not Recruiting to Recruitingv9 Show 9 more changesShow less
    • Start date: Sep 25, 2019 to Jan 21, 2025
    • Primary endpoints: 6 to 13
    • Interventions: Eye Movement Desensitization and Reprocessing therapy (Behavioral), Multifocal transcranial Current Stimulation (Other) to Eye Movement Desensitization and Reprocessing therapy (Behavioral), transcranial Direct Current Stimulation (Other)
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: 2 to 6
    • Study description shortened, about 137 words
    • Site details revised
    • Collaborators: 2 to 1
    • Publications: 14 to 15
  2. Trial status: Suspended to Active, Not Recruitingv8 Show 5 more changesShow less
    • Enrollment target: 45 to 96
    • Primary completion date: May 31, 2023 to Dec 31, 2026
    • Study completion date: Sep 30, 2023 to Dec 31, 2026
    • Study title revised
    • Study description expanded, about 1 word
  3. 2 versions Re-verified since Mar 17, 2021, no change to tracked fieldsv6-v7
  4. Trial status: Recruiting to Suspended Sponsor's reason: To the impossibility to visit patients at the hospital by COVID-19.When the situation stabilizes, we will start the study again.
    • Primary completion date: May 31, 2022 to May 31, 2023
    • Study completion date: Sep 30, 2022 to Sep 30, 2023
    • Site details revised
    v5
  5. Interventions: Eye Movement Desensitization and Reprocessing therapy (Behavioral), Transcranial Direct Current Stimulation (Other) to Eye Movement Desensitization and Reprocessing therapy (Behavioral), Multifocal transcranial Current Stimulation (Other)
    • Study description revised
    • Study title revised
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Re-verified, no change to tracked fieldsv3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Sep 9, 2019 to Sep 25, 2019
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Parc de Salut Mar
36 trials monitored
See 1 trial at risk
Anxiety
3,263 trials monitored
See 159 trials at risk
Depression
3,055 trials monitored
See 173 trials at risk
PTSD
889 trials monitored
See 54 trials at risk
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.
Trial Details
NCT Number NCT04084795
Lead Sponsor Parc de Salut Mar
Collaborators: Universitat Oberta de Catalunya
Conditions
(from sponsor)		 Fibromyalgia, Psychological Trauma, Depressive Symptoms, Anxiety
Related terms Anxiety Disorders, Depression, Fibromyalgia, Major Depressive Disorder, Psychological Trauma, Stress Disorders, Post-Traumatic
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov