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Home-based Transcranial Direct Current Stimulation (tDCS) Compared to Duloxetine: Non-inferiority Clinical Trial (FIBROSTIM)

RecruitingNAAges 18 Years - 75 YearsFemaleHospital de Clinicas de Porto Alegre
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In plain words

What the trial is, and whether it could suit you

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 70% of patients discontinue treatment with antidepressants and anticonvulsants due to adverse effects or low efficacy, and more than 30% resort to opioid use. Given the treatment challenges and the scarcity of safe alternatives, there is growing interest in interventions such as transcranial direct current stimulation (tDCS), which has shown efficacy in improving symptoms and functionality, with low cost and few side effects. In this context, we designed a randomized, double-blind, double-dummy clinical trial to compare the non-inferiority of 28 home-based anodal tDCS (2 mA) applied over the primary motor cortex (M1) versus duloxetine 60 mg. Both treatments will be combined with physical exer

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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
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What it tests

  • Transcranial direct current stimulation (tDCS) plus placebo.
  • Duloxetine (60 mg) once daily
  • Home-based transcranial direct current stimulation
  • Duloxetine 60 mg
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Where

1 site
Hospital de Clรญnicas de Porto Alegre
Porto Alegre, Brazil
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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