Home-based brain stimulation versus duloxetine for fibromyalgia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.