Home-based brain stimulation versus duloxetine for fibromyalgia
Home-based Transcranial Direct Current Stimulation (tDCS) Compared to Duloxetine in the Treatment of Fibromyalgia: a Randomized Non-inferiority Clinical Trial (FIBROSTIM)
NA · Hospital de Clinicas de Porto Alegre · NCT07203339
This trial will test whether home-based transcranial direct current stimulation (tDCS) works as well as duloxetine 60 mg for women with moderate-to-severe fibromyalgia when combined with exercise and pain education.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 610 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Hospital de Clinicas de Porto Alegre (other) |
| Locations | 1 site (Porto Alegre, Rio Grande do Sul) |
| Trial ID | NCT07203339 on ClinicalTrials.gov |
What this trial studies
Women with fibromyalgia (age 18–75, pain ≥4/10) are randomized in a double-blind, double-dummy non-inferiority design to receive either 28 sessions of home-based anodal tDCS (2 mA over primary motor cortex) plus placebo pills or duloxetine 60 mg daily plus sham tDCS, with both arms receiving physical exercise and pain education. Treatments are self-administered at home with remote supervision and adherence monitoring. Outcomes include multidimensional pain and function measures and exploratory biomarkers such as BDNF and EEG. The protocol excludes participants with implanted brain or cardiac devices, uncontrolled medical or psychiatric conditions, pregnancy, or those living more than 250 km from Porto Alegre.
Who should consider this trial
Good fit: Women aged 18–75 with a clinical diagnosis of fibromyalgia (ACR 2010–2016), average pain ≥4/10, right-handed, literate, able to swallow tablets, and willing to use home tDCS and keep stable medication doses are ideal candidates.
Not a fit: People with implanted brain or cardiac devices, active uncontrolled systemic or psychiatric disease, pregnancy, neurological disorders, or those living beyond 250 km of Porto Alegre are not eligible and would not receive benefit from this trial.
Why it matters
Potential benefit: If successful, home tDCS could offer a low-cost, low-side-effect alternative to duloxetine for reducing pain and improving function in women with fibromyalgia.
How similar studies have performed: Previous studies have shown tDCS can reduce fibromyalgia symptoms with few side effects and duloxetine is an established treatment, but a head-to-head home-based non-inferiority comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility Criteria Inclusion Criteria: * Woman aged between 18 and 75 years * Right-handed * Literate in reading and writing * Clinical diagnosis of fibromyalgia based on the American College of Rheumatology (ACR) 2010-2016 criteria * Numeric Pain Scale (NPS) score ≥ 4 on most days in the past 30 days * Agree no changes in medication dosage during the treatment period (except for analgesics) * Able to swallow tablets * Able to understand instructions for using tDCS at home Exclusion Criteria: * Living more than 250 km from Porto Alegre * Pregnancy * Decompensated systemic diseases * Chronic inflammatory rheumatologic diseases * Untreated hypothyroidism * Active cancer under treatment * Alcohol or drug abuse in the past 6 months * Decompensated psychiatric disorders with suicide risk and a defined plan * Use of duloxetine at a dose \> 60 mg/day * Metal implants in the brain * Implanted brain medical devices * Cardiac pacemaker * Cochlear implant * Neurological disorders * History of traumatic brain injury or neurosurgery
Where this trial is running
Porto Alegre, Rio Grande do Sul
- Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (RECRUITING)
Study contacts
- Study coordinator: WOLNEI CAUMO, MD, PhD
- Email: wcaumo@hcpa.edu.br
- Phone: 55 51 3359 6377
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibromyalgia, tDCS, Duloxetine, BDNF, EEG, Transcranial Direct Current Stimulation, Biomarkers, Precision Medicine