Hospital de Clínicas de Porto Alegre is set to initiate a groundbreaking clinical trial evaluating the effectiveness of home-based transcranial direct current stimulation (tDCS) against duloxetine, a widely prescribed pharmacological treatment for fibromyalgia. The study, titled FIBROSTIM, aims to provide evidence for actionable alternatives in fibromyalgia treatment approaches, particularly for patients who may benefit from non-drug therapies. As of October 2025, this study is listed as “Not yet recruiting.”
What is the FIBROSTIM Study?
The FIBROSTIM clinical trial seeks to examine whether non-invasive home-based tDCS can achieve therapeutic outcomes comparable to duloxetine. tDCS utilizes a mild electrical current applied through electrodes placed on the scalp to modulate neuronal activity. Duloxetine, on the other hand, is a serotonin-norepinephrine reuptake inhibitor (SNRI) proven effective in managing chronic pain, including fibromyalgia. This trial aims to establish non-inferiority between these distinct interventions.
Why Could This Trial Be Important?
Fibromyalgia affects millions worldwide, characterized by widespread musculoskeletal pain, fatigue, and cognitive disturbances. While pharmacological treatments like duloxetine are effective, some patients prefer or require non-drug interventions due to adverse side effects or contraindications. Home-based tDCS offers a promising alternative, empowering patients to manage symptoms autonomously with fewer potential systemic effects.
Additionally, neurophysiological markers such as brain-derived neurotrophic factor (BDNF) levels and EEG data will be incorporated into the study. These biomarkers could offer deeper insights into fibromyalgia’s mechanisms and how these treatments impact neural plasticity and pain modulation.
Clinical Trial Details
Sponsors: The trial is sponsored by Hospital de Clínicas de Porto Alegre, emphasizing its institutional credibility.
Interventions: Participants in the trial will either use a home-based transcranial direct current stimulation device combined with a placebo or take duloxetine at a daily dose of 60 mg. The study protocol will monitor outcomes in symptom management and provide comparative data on safety and usability.
Key Outcome Measures: The researchers will assess pain levels, functionality, quality of life, BDNF levels, and EEG data over time. This robust dataset aims to provide generalizable evidence to inform clinical practice.
Status: As of October 2025, recruitment has not yet commenced. Updates are expected through ClinicalTrials.gov (study record here).
Frequently Asked Questions
FAQ Section:
- What is duloxetine?
Duloxetine is an SNRI medication approved for treating conditions like fibromyalgia, generalized anxiety disorder, and chronic musculoskeletal pain.
- How does tDCS function?
tDCS applies a low electrical current through electrodes on the scalp to influence brain activity regions linked to pain and mood regulation.
- When does recruitment begin?
The trial is listed as “Not yet recruiting” as of October 2025. Future status updates will be published on ClinicalTrials.gov.
Conclusion
The FIBROSTIM trial has the potential to shift fibromyalgia treatment paradigms, providing evidence for a scalable, home-based alternative to pharmacological therapies. Clinical and regulatory teams should monitor this study closely for findings that could impact device approvals or therapeutic guidelines.
Disclaimer
This article is for informational purposes only and does not constitute legal or medical advice. Always consult professional guidance before making regulatory or clinical decisions.
Announcement Link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07203339?term=medical+device