Auricular Vagus Nerve Stimulation Following Subarachnoid Hemorrhage
This study is looking at whether a non-invasive treatment called auricular vagus nerve stimulation (VNS) can help patients who have experienced a spontaneous subarachnoid hemorrhage (bleeding in the space around the brain). Auricular VNS involves using a device to stimulate a nerve in the ear. Researchers want to see if this stimulation can lower inflammation in the blood and spinal fluid, and if it leads to better recovery outcomes. You might be able to join if you've had a spontaneous subarachnoid hemorrhage and are at least 18 years old. However, you cannot participate if your hemorrhage was caused by trauma, if you are undergoing chemotherapy, taking immunosuppressive medications, have a pacemaker, or have prolonged slow heart rate upon admission. The study aims to enroll 50 participants and its current status is unclear.
- Study design
- This is an interventional study where participants will be randomly assigned to receive either auricular VNS or a sham (inactive) device. It aims to enroll 50 participants.
- What's involved
- Blood and cerebrospinal fluid (CSF) will be collected upon admission and regularly throughout your hospital stay. Clinical events will be tracked during your hospitalization.
- Compensation
- Not stated in the trial record.
- Follow-up
- Outcomes will be tracked at discharge and during follow-up visits for up to 2 years after discharge.
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Auricular VNS Following Subarachnoid Hemorrhage
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Eric C Leuthardt, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Inflammatory markers in the serum on admissionOn hospital day 1
TNF alpha from blood draw
- Change in inflammatory markers in the serumThrough hospital admission, average of 4 weeks
TNF alpha from blood draws
- Inflammatory markers in the CSF on admissionOn hospital day 1
TNF alpha from cerebrospinal fluid
- Change in inflammatory markers in the CSFThrough hospital admission, average of 4 weeks
TNF alpha from cerebrospinal fluid
- Cerebral vasospasmThrough hospital admission, average of 4 weeks
Presence of moderate/severe radiographic vasospasm
- HydrocephalusThrough hospital admission, average of 4 weeks
Need for permanent CSF diversion via a ventricular shunt