Stanford University has announced a new clinical trial focused on using vagus nerve stimulation (VNS) to address treatment-resistant depression. The study, titled “Vagus Nerve Stimulation (VNS) Electroencephalogram (EEG) Protocol Supplement,” is registered but not yet recruiting participants as of January 12, 2026. It aims to investigate how VNS impacts the brain’s electrical activity, as measured by electroencephalograms (EEGs).
The trial’s innovative approach highlights its potential significance for the clinical and regulatory community interested in depression treatments and medical device advancements. With increasing attention on neuromodulation as an alternative mechanism for addressing severe mental health conditions, this trial could shape future standards for VNS device protocols and usage.
In this article:
- What changed?
- Who is affected?
- Trial details
- Device safety and compliance
- FAQ
- Conclusion
- Disclaimer
- Announcement line
What changed?
This upcoming trial introduces an EEG-based supplement protocol to vagus nerve stimulation treatments. Traditionally, VNS targets the vagus nerve to affect mood regulation and depressive symptoms. The inclusion of EEG metrics in data collection marks a progressive step in understanding neuromodulation’s interplay with brain activity. By focusing on treatment-resistant depression, this research could provide new evidence for refining device performance and application guidelines for clinical practice.
Who is affected?
The target population for this study includes individuals suffering from treatment-resistant depression, a condition where standard interventions like therapy and pharmacological treatments fail to achieve satisfactory outcomes. This trial will likely attract attention from clinical teams, medical researchers, regulatory experts, and manufacturers of neuromodulation devices. Additionally, healthcare institutions focusing on mental health therapies and device integration may find the outcomes relevant.
Trial details
The clinical trial is led by Stanford University’s team and investigates the use of a VNS device designed to deliver controlled stimulation to the vagus nerve. Researchers will use EEG recordings to monitor cortical responses and determine the device’s effects on brain functionality. This combined methodology could pave the way for tailored stimulation protocols and contribute to defining indicators for efficacy and safety.
As of the publication date, recruitment for the trial is yet to begin. Interested candidates will likely involve carefully screened participants who exhibit resistance to established depression treatments. Results from this study will undergo stringent analysis for regulatory submission, ensuring compliance with medical standards and performance benchmarks.
Device safety and compliance
Safety and compliance are central to the design and execution of any trial involving medical devices. The device being utilized in this study has to comply with regulatory frameworks such as those outlined in MDR Annex XIV. Detailed monitoring through EEG activity ensures that adverse effects are carefully tracked and mitigated, aligning with patient safety objectives throughout the trial duration.
Stanford University will also submit performance data to ensure the device demonstrates intended clinical benefits. This trial complements ongoing efforts in device innovation, promoting robust standards for neuromodulation protocols across the medical field.
FAQ
1. What is vagus nerve stimulation (VNS)?
VNS involves electrical stimulation of the vagus nerve, a critical nerve for regulating mood and physiological functions. Devices designed for VNS aim to treat neurological and psychiatric conditions.
2. Why is EEG included in this study?
EEG offers valuable data on brainwave activity, helping researchers understand how VNS interacts with neurological patterns linked to depression.
3. Is this trial currently open for participants?
No, recruitment has not started as of January 12, 2026. Updates will be provided on the official ClinicalTrials.gov platform.
4. Who is sponsoring this trial?
Stanford University is the study sponsor, ensuring scientific integrity and compliance with regulatory protocols.
Conclusion
This clinical trial represents a forward-looking approach to managing treatment-resistant depression using VNS enhanced by EEG monitoring. For healthcare professionals and device manufacturers, the results could redefine therapeutic protocols and expand options for patients. Stakeholders should closely follow updates to remain informed about recruitment and data release timelines.
Disclaimer
This article is for informational purposes only and does not constitute legal or clinical advice. Professionals should refer to official study documentation and regulatory guidelines for detailed recommendations.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07310381?term=medical+device