EMDR combined with gentle brain stimulation (tDCS) for fibromyalgia
Official title: Augmentation of EMDR With Transcranial Direct Current Stimulation (tDCS) in the Treatment of Fibromyalgia: a Double-blind Randomized Controlled Trial
Run by Parc de Salut Mar · NCT04084795 · Data updated 2026-11-12
This project will test whether adding non-invasive brain stimulation (tDCS) to EMDR helps people with fibromyalgia who also have trauma-related symptoms, depression, or anxiety.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 96 (estimated) |
| Sponsor | Parc de Salut Mar Academic / other |
| Locations | 1 site (Barcelona, Catalonia) |
| Status | Recruiting |
| Started | January 21, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | August 3, 2025 |
| Trial ID | NCT04084795 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–70 with diagnosed fibromyalgia who report an average pain score of at least 4/10 in the prior two weeks, have current trauma-related symptoms plus depressive and/or anxiety symptoms, and are on stable medication for at least two weeks.
✕Probably not a fit
Patients with autoimmune or serious neurological/medical diseases, bipolar or psychotic disorders, active suicidal ideation, recent substance dependence, recent EMDR (within two years), pregnancy, metallic head implants, skin sensitivity conditions, pending litigation, or those without trauma-related symptoms are unlikely to qualify or receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers in Barcelona will randomize eligible patients to receive EMDR combined with active tDCS, EMDR with sham tDCS, or treatment as usual. tDCS is applied during EMDR sessions to modulate brain activity related to pain and stress while EMDR targets trauma-related memories. The trial measures pain intensity, depressive and anxiety symptoms, and trauma-associated symptoms after therapy and at follow-up. Comparisons will show whether active tDCS enhances or prolongs EMDR benefits beyond EMDR with sham stimulation or usual care.
Why it matters
Potential benefit: If successful, the combination could produce larger and longer-lasting reductions in pain, mood symptoms, and trauma-related distress for people with fibromyalgia.
How similar studies have gone: EMDR is an established therapy for PTSD and small studies suggest benefit in fibromyalgia, and tDCS has shown modest effects on pain, but combining EMDR with tDCS is a relatively new approach with limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Comorbid autoimmune or chronic inflammatory disease * Neurological or serious medical diseases * Bipolar disorder, schizoaffective disorder and schizophrenia * Suicidal ideation * Previous EMDR therapy in the past two years * Substance abuse/dependency within 1 month prior to participation (except for nicotine abuse/dependency), * Pending FM-related litigation or disability * Metallic implants in the head * Positive test for pregnancy * Skin sensitivity diseases (psoriasis, eczema, dermatitis, etc.)
Where it's running
-
Centre Forum (Parc de Salut Mar)
Barcelona, Catalonia, Spain Recruiting
Study contacts
- Principal investigator: Benedikt L. Amann, M.D. — Parc de Salut Mar
- Study coordinator: Alicia Valiente Gómez, M.D.
- Email: avaliente@researchmar.net
- Phone: (0034)933268500
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.