Testing a device to stimulate the vagus nerve after a brain hemorrhage
Investigating the Tolerability and Feasibility of Transcutaneous Vagus Nerve Stimulation Following Aneurysmal Subarachnoid Haemorrhage
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Sheffield, South Yorkshire) |
| Trial ID | NCT06374693 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with prior vagus nerve stimulation treatment or certain cardiac conditions may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Sheffield, South Yorkshire
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.