Testing a device to stimulate the vagus nerve after a brain hemorrhage
Official title: Investigating the Tolerability and Feasibility of Transcutaneous Vagus Nerve Stimulation Following Aneurysmal Subarachnoid Haemorrhage
Run by Sheffield Teaching Hospitals NHS Foundation Trust · NCT06374693 · Data updated 2026-11-12
This study is testing whether a device that stimulates the vagus nerve can help people recover better after a brain hemorrhage caused by a burst aneurysm.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Sheffield, South Yorkshire) |
| Status | Recruiting |
| Started | April 17, 2024 |
| Main results expected | May 30, 2026 |
| Study ends | July 31, 2026 |
| Registry record updated | March 20, 2026 |
| Trial ID | NCT06374693 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 who have been admitted to the neurosurgery department with a confirmed aneurysmal subarachnoid hemorrhage and have undergone aneurysm securing within the last five days.
✕Probably not a fit
Patients with prior vagus nerve stimulation treatment or certain cardiac conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study investigates the tolerability and feasibility of transcutaneous vagus nerve stimulation (tVNS) in patients who have recently experienced a subarachnoid hemorrhage from a cerebral aneurysm rupture. Participants will be randomly assigned to receive either active tVNS or a sham treatment for 45 minutes twice daily over five days following their aneurysm securing procedure. The study aims to evaluate the success criteria for tolerability and feasibility while also exploring potential effects on clinical outcomes and mechanisms. This research is significant as it seeks to address complications associated with subarachnoid hemorrhage, which can lead to increased disability and mortality.
Why it matters
Potential benefit: If successful, this approach could reduce complications and improve recovery outcomes for patients following a subarachnoid hemorrhage.
How similar studies have gone: While non-invasive vagus nerve stimulation has been explored for headache relief, this specific application in the acute phase following subarachnoid hemorrhage is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 * Admitted to STH (Sheffield Teaching Hospital) neurosurgery department * Confirmed aneurysmal SAH on vascular imaging * Within 5 days of 'Securing' aneurysm (i.e., successfully coiled or surgically following rupture) Exclusion Criteria: * Current or prior use of a vagus nerve stimulation * Symptomatic bradycardia or PPM insertion * Complete heart block * Implantation of any other electrical stimulator (e.g. DBS)
Where it's running
-
University of Sheffield
Sheffield, South Yorkshire, United Kingdom Recruiting
Study contacts
- Principal investigator: Dr Ali Ali — Sheffield Teaching Hospitals NHS Foundation Trust
- Study coordinator: Dr Ali Ali
- Email: Ali.ali@sheffield.ac.uk
- Phone: +4401142159114
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.