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L Yousefi Soorani, B Shafiei Bafti, S M Homam...
https://pubmed.ncbi.nlm.nih.gov/36352022Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
FEMALE
ID07203339
Home-based Transcranial Direct Current Stimulation (tDCS) Compared to Duloxetine in the Treatment of Fibromyalgia: a Randomized Non-inferiority Clinical Trial (FIBROSTIM)
Led by Hospital de Clinicas de Porto Alegre · Updated on 2026-01-06
610
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Fibromyalgia is a condition marked by widespread pain, fatigue, poor sleep, and cognitive changes that lower quality of life and often cause work absence or early retirement. Many patients stop using antidepressants or anticonvulsants due to side effects or poor results, and some rely on opioids. Because treatment options are limited, researchers are studying transcranial direct current stimulation (tDCS) as a potential alternative, comparing its effects to duloxetine in a randomized, double-blind clinical trial to see if tDCS is not worse than duloxetine when both are combined with exercise and pain education. Participants will be divided into three groups: one receiving 28 daily home-based sessions of active anodal tDCS targeting the primary motor cortex, combined with placebo medication; another taking duloxetine at varying doses combined with sham tDCS; and a third receiving sham tDCS with placebo pills. Duloxetine dosing starts with 30 mg and increases to 60 mg, tapering off after treatment. The tDCS sessions last 20 minutes each, with electrodes placed using special caps. Both treatments include physical exercises and educational sessions on pain. The study includes a run-in period, treatment phase, and follow-up assessments at 3, 6, and 12 months. During the study, participants will perform weekly home assessments of pain interference, global improvement, quality of life, cognitive symptoms, and pain inhibitory system function. Secondary outcomes include depressive symptoms, sleep quality, circadian rhythm, analgesic use, functional capacity, various pain thresholds, cognitive tests, treatment adherence, side effects, and satisfaction. Biological markers like genetic variants, inflammatory proteins, and brain activity will also be analyzed. Safety and progress will be monitored with an interim analysis to decide on continuing or stopping the trial. The total involvement spans treatment and follow-up visits over a year.
CONDITIONS
Brief Title
Home-based Transcranial Direct Current Stimulation (tDCS) Compared to Duloxetine: Non-inferiority Clinical Trial (FIBROSTIM)
Who Can Participate
Age: 18Years - 75Years
FEMALE
Eligibility Criteria
You may qualify if you...
- 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 4 on most days in the past 30 days
- Agree to 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
You will not qualify if you...
- 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 �b4 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - 3 weeks
Participants undergo a run-in period with medication dosing and baseline assessments including home-based weekly evaluations, actigraph use, and monitoring of analgesic use.
Weekly home-based assessments during Weeks 1 to 3
Treatment
Duration - 4 weeks
Participants receive either home-based transcranial direct current stimulation (tDCS) or duloxetine medication combined with pain neuroscience education and physical exercises. The tDCS sessions are self-administered daily at home. Medication is dispensed in scheduled visits.
Daily home-based tDCS sessions (28 sessions) and 3 medication dispensing visits
Follow-up
Duration - Up to 12 months post-treatment
Participants are assessed at multiple points after treatment to evaluate long-term effects on symptoms, cognitive function, and quality of life.
Assessments at 3, 6, and 12 months post-treatment
Trial Site Locations
Total: 1 location
1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Actively Recruiting
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Research Team
W
WOLNEI CAUMO, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Impact of multiple-session home-based transcranial direct current stimulation (M-HB-tDCS) on eating behavior in fibromyalgia: A factorial randomized clinical trial.
Manoela N da Jornada, Luciana C Antunes, Camila Alves...
https://pubmed.ncbi.nlm.nih.gov/38336340Evidence-Based Guidelines and Secondary Meta-Analysis for the Use of Transcranial Direct Current Stimulation in Neurological and Psychiatric Disorders.
Felipe Fregni, Mirret M El-Hagrassy, Kevin Pacheco-Barrios...
https://pubmed.ncbi.nlm.nih.gov/32710772Efficacy of Home-Based Transcranial Direct Current Stimulation Over the Primary Motor Cortex and Dorsolateral Prefrontal Cortex in the Disability Due to Pain in Fibromyalgia: A Factorial Sham-Randomized Clinical Study.
Wolnei Caumo, Rael Lopes Ramos, Paul Vicuña Serrano...
https://pubmed.ncbi.nlm.nih.gov/37689323Motor Cortex Excitability and BDNF Levels in Chronic Musculoskeletal Pain According to Structural Pathology.
Wolnei Caumo, Alícia Deitos, Sandra Carvalho...
https://pubmed.ncbi.nlm.nih.gov/27471458Impact of Bifrontal Home-Based Transcranial Direct Current Stimulation in Pain Catastrophizing and Disability due to Pain in Fibromyalgia: A Randomized, Double-Blind Sham-Controlled Study.
Wolnei Caumo, Rael Lopes Alves, Paul Vicuña...
https://pubmed.ncbi.nlm.nih.gov/34785366Large Treatment Effect With Extended Home-Based Transcranial Direct Current Stimulation Over Dorsolateral Prefrontal Cortex in Fibromyalgia: A Proof of Concept Sham-Randomized Clinical Study.
Aline P Brietzke, Maxciel Zortea, Fabiana Carvalho...
https://pubmed.ncbi.nlm.nih.gov/31356985