On December 15, 2025, a clinical trial investigating the effects of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on brain connectivity in chronic stroke patients was highlighted on ClinicalTrials.gov. Sponsored by Clinique Les Trois Soleils, this trial explores how active and sham taVNS devices impact functional brain connectivity during rest.
What changed?
Clinique Les Trois Soleils is now actively recruiting participants for a pioneering study examining taVNS treatment for chronic stroke patients. This trial aims to uncover whether transcutaneous stimulation of the auricular branch of the vagus nerve can influence inter-regional brain connections while at rest.
The study employs both active stimulation using taVNS devices and a control arm using sham devices. This allows researchers to assess any functional connectivity changes attributable to the intervention.
Study details and methodology
The research categorizes participants into two arms:
- Active taVNS arm: Patients receive true vagus nerve stimulation using an FDA-regulated medical device.
- Sham control arm: Patients interact with a similar device yet receive no active stimulation.
Clinique Les Trois Soleils offers robust oversight, complying with applicable clinical requirements. The study isolates the effects of taVNS from placebo responses to ensure reliable results.
The trial focuses on chronic stroke patients, a group often underserved by conventional rehabilitation strategies. Data collection will assess key biomarkers of brain functional connectivity, supporting future device development pathways and clinical applications.
Why this matters for stroke treatment
Stroke recovery often leaves patients struggling with sustained impairments in motor, cognitive, or emotional functions. Although physical and neurological therapies help some patients regain faculties, certain brain connectivity disruptions persist.
taVNS could open new therapeutic avenues by modulating central networks responsible for recovery. Devices like those employed in this study operate under regulated safety standards to provide non-invasive neural stimulation. The trial outcomes will demonstrate whether brain connectivity improvements correlate with tangible quality-of-life upgrades.
If successful, this study may accelerate the inclusion of taVNS technologies in standard neurological rehabilitation protocols, opening market and regulatory pathways for innovation.
FAQ
- 1. What is taVNS?
- taVNS stands for transcutaneous auricular vagus nerve stimulation. It involves non-invasive stimulation of the vagus nerve via the ear’s surface using medical devices.
- 2. Why study stroke patients?
- Stroke often disrupts important brain networks. Understanding whether taVNS improves connectivity may enhance long-term therapeutic outcomes for these patients.
- 3. How are sham devices used in trials?
- Sham devices mimic active ones but provide no real stimulation, which allows researchers to differentiate therapeutic effects from placebo responses.
- 4. How is functional connectivity measured?
- Researchers use imaging tools like functional MRI (fMRI) to observe synchronized brain activity across different regions of interest.
Conclusion
This study marks an important step toward integrating taVNS into clinical stroke treatment frameworks. Supported by Clinique Les Trois Soleils, the research promises scientifically valuable insights while meeting high regulatory standards.
Chronic stroke patients, clinicians, and rehabilitation specialists should monitor progress as taVNS continues to demonstrate therapeutic potential.
Disclaimer
This content is intended for clinical and regulatory professionals. It is informational only and does not constitute legal advice.
Announcement information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07282106?term=medical+device