On October 9, 2025, Vrije Universiteit Brussel announced a new clinical study aimed at evaluating the added value of transcranial direct current stimulation (tDCS) devices in combination with aerobic exercise for individuals suffering from chronic widespread pain, including fibromyalgia. While the study is not yet recruiting, the initiative represents a significant step in exploring innovative therapeutic interventions for these challenging conditions.
In this article:
What is the study about?
Chronic widespread pain, including fibromyalgia, presents complex challenges for patients and healthcare providers. The study aims to investigate whether combining active tDCS—a non-invasive neuromodulation device—with aerobic exercise can improve clinical outcomes compared to exercise therapy alone or exercise paired with sham tDCS.
tDCS delivers low electrical currents to targeted areas of the brain via electrodes, which may help modulate pain perception and enhance neuromuscular function. Aerobic exercise is already a well-documented method to improve pain symptoms in fibromyalgia, but the synergistic effect with tDCS remains underexplored.
How is the study organized?
The clinical trial sponsored by Vrije Universiteit Brussel will include three intervention groups:
- Active tDCS + Aerobic Exercise: Participants will utilize active tDCS alongside standardized aerobic exercise protocols.
- Sham tDCS + Aerobic Exercise: This group will serve as a control by utilizing inactive (sham) tDCS devices in combination with exercise.
- Aerobic Exercise Alone: The baseline group offering standard therapy without tDCS intervention.
Although recruitment has not started, clinical teams are expected to focus on safety, device performance, and therapeutic efficacy. The results could pave the way for regulatory and medical device approvals depending on the data strength.
Why this research matters?
Fibromyalgia and chronic widespread pain affect millions globally, often leading to decreased quality of life and limited treatment options. Combining devices like active tDCS with exercise therapy aligns with innovations in personalized medicine and multimodal pain management strategies.
By focusing on both behavioral and neurophysiological approaches, the study aims to bridge gaps in non-pharmacological treatment and provide insights for the medical device industry. Such data could support claims of safety and performance under regulatory frameworks like MDR Annex XIV.
FAQ
1. What conditions are being studied?
The trial focuses on chronic widespread pain and fibromyalgia.
2. What device is used in the study?
An active tDCS device will be used, alongside a sham (inactive) tDCS device for comparison.
3. Who is sponsoring the study?
The study is sponsored by Vrije Universiteit Brussel.
4. Is recruitment open?
Recruitment for this study has not begun yet.
Conclusion
Medical and regulatory professionals should track this study’s development to understand the implications for non-invasive neuromodulation in chronic pain therapy. New findings could shift therapeutic paradigms and result in advances for medical devices targeting pain management.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or regulatory advice. Please consult appropriate professionals for guidance.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07212829?term=medical+device