On February 15 2026 a not yet recruiting trial evaluates non invasive auricular vagus nerve stimulation to lower inflammation and injury biomarkers after ischemic stroke due to large vessel occlusion.
The study is sponsored by Washington University School of Medicine and uses two devices in parallel terms: an active transcutaneous auricular vagal nerve stimulation device and a sham transcutaneous vagal nerve stimulation device. The aim is to generate comparative data on safety and biomarker outcomes in the context of acute ischemic stroke with large vessel occlusion.
What changed in stroke neuromodulation research?
The registrational record highlights an investigational device approach using transcutaneous auricular vagus nerve stimulation to address inflammatory processes and injury biomarkers after ischemic stroke. This is paired with a sham control to help determine the device effect relative to placebo. The record notes that enrollment has not yet begun, situating this work in early trial development.
What are the trial design details?
The trial compares the active auricular vagal nerve stimulation device with a sham transcutaneous stimulation. The sponsor listed is Washington University School of Medicine. The study is registered on ClinicalTrials.gov under NCT07404852, providing public access to protocol specifics and status. The intervention is non invasive and intended to be delivered at the auricular region of the ear with standard device wearability, under supervision of clinical investigators. The design reflects standard regulatory practices for device trials with blinding and control arms to assess safety and biomarker outcomes.
What is the status of the trial?
According to the registry, the study is not yet recruiting. This indicates that regulatory submissions, site preparations, and potential ethics approvals are underway before any participant is enrolled. Regulatory teams will monitor any updates to the trial status as it evolves toward enrollment.
What are the regulatory and safety considerations?
As a device based intervention in the stroke setting, the trial will evaluate safety performance in addition to biomarker outcomes. The sponsor and investigators will document adverse events, device performance, and any protocol deviations in accordance with regulatory expectations and MDR or other applicable standards. Statements herein reflect the source record and sponsor information available in the ClinicalTrials.gov entry.
What outcomes are measured and why?
The primary focus is on biomarkers of inflammation and brain injury as potential indicators of device effect. The trial may also monitor clinical safety endpoints and device tolerability as part of a regulatory grade evaluation. The approach aligns with standard early phase device trials seeking signals of biological activity and safety in a high risk population.
FAQ
- 1 What is the purpose of the trial To evaluate whether non invasive auricular vagus nerve stimulation can influence biomarkers of inflammation and brain injury after stroke with large vessel occlusion.
- 2 Who is sponsoring the study Washington University School of Medicine is listed as the sponsor.
- 3 What is the current status Not yet recruiting, with regulatory and site preparations ongoing.
- 4 Where can I get more information For full information see the ClinicalTrials.gov record at https://clinicaltrials.gov/study/NCT07404852?term=medical+device.
Conclusion and implications for readers
The trial represents a careful regulatory mindful assessment of a non invasive neuromodulation device in the stroke setting. Regulators, clinicians, and industry stakeholders will watch enrollment progress and reported safety data as it becomes available to inform future use in stroke care pathways.
Disclaimer for professionals
This material is for informational purposes only and does not constitute legal advice. It does not replace regulatory submissions or formal communications from the sponsor or regulators.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07404852?term=medical+device