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Home-based Transcranial Direct Current Stimulation (tDCS) Compared to Duloxetine:On-inferiority Clinical Trial (FIBROSTIM)
610 patients around the world
Available in
Brazil
Hospital de Clinicas de Porto Alegre
1
Research sites
610
Patients around the world
This study is for people with
Fibromyalgia
Requirements for the patient
To 75 Years
Female
Medical requirements
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.
Sites
Hospital de Clínicas de Porto Alegre
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Rua Ramiro Barcelos, 2350, Av. Protásio Alves, 211 - Santa Cecília, Porto Alegre - RS, 90035-903
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Study
FIBROSTIM
Sponsor
Hospital de Clinicas de Porto Alegre
Study type
Interventional
Conditions
Fibromyalgia
Requirements
To 75 Years
Female
Unique study ID
clinicaltrials.gov
NCT07203339
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