Using auricular vagus nerve stimulation to improve outcomes after subarachnoid hemorrhage
Transcutaneous Auricular Vagus Nerve Stimulation Following Spontaneous Subarachnoid Hemorrhage
This study is testing if a new treatment using ear stimulation can help people recover better and have fewer complications after a brain bleed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT04557618 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of non-invasive auricular vagal nerve stimulation (VNS) on inflammatory markers and clinical outcomes in patients with spontaneous subarachnoid hemorrhage (SAH). Participants will be randomly assigned to receive either active VNS or sham stimulation, with blood and cerebrospinal fluid samples collected to assess inflammation. The study will track various clinical events during hospitalization and measure functional outcomes at discharge and follow-up visits over two years. The goal is to determine if VNS can improve recovery and reduce complications associated with SAH.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with spontaneous subarachnoid hemorrhage.
Not a fit: Patients with trauma-induced subarachnoid hemorrhage or those on immunosuppressive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery and reduced complications for patients following subarachnoid hemorrhage.
How similar studies have performed: Previous studies have shown promising results for vagal nerve stimulation in inflammatory conditions, suggesting potential success for this approach in SAH.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Spontaneous subarachnoid hemorrhage Exclusion Criteria: * Trauma-induced subarachnoid hemorrhage * Ongoing chemotherapy * Taking immunosuppressive medications for other medical illnesses * Presence of a pacemaker * Prolonged bradycardia at time of admission
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Eric C Leuthardt, MD — Washington University School of Medicine
- Study coordinator: Anna L Huguenard, MD
- Email: ahuguenard@wustl.edu
- Phone: 3144506698
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.