Status:
RECRUITING
Home-based Transcranial Direct Current Stimulation (tDCS) Compared to Duloxetine: Non-inferiority Clinical Trial (FIBROSTIM)
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Conditions:
Fibromyalgia (FM)
tDCS
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
Fibromyalgia is characterized by widespread pain, fatigue, non-restorative sleep, and psychocognitive alterations, compromising quality of life and leading to absenteeism and early retirement. Up to 7...
Eligibility Criteria
Inclusion
- Eligibility 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
- 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
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
610 Patients enrolled
Trial Details
Trial ID
NCT07203339
Start Date
September 30 2025
End Date
December 1 2028
Last Update
January 6 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil