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Vagus Nerve Stimulation

Ear Nerve Stimulation for Brain Bleed

N/A
Recruiting
Led By Eric C Leuthardt, MD
Research Sponsored by Anna Huguenard
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Spontaneous subarachnoid hemorrhage
Be older than 18 years old
Must not have
Taking immunosuppressive medications for other medical illnesses
Ongoing chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years

Summary

This trial will test whether a non-invasive ear nerve stimulator can lower inflammation and improve outcomes for people who have had a spontaneous brain bleed.

Who is the study for?
This trial is for individuals who have experienced a spontaneous subarachnoid hemorrhage, which is bleeding in the space around the brain. It's not open to those with trauma-induced bleeding, anyone on chemotherapy or immunosuppressive medications, people with pacemakers, or patients who had very slow heart rates when admitted.
What is being tested?
The study tests auricular vagus nerve stimulation (VNS), a non-invasive treatment that involves stimulating a nerve in the ear to see if it can reduce inflammation and improve recovery after a spontaneous subarachnoid hemorrhage. Some participants will receive sham VNS as a comparison.
What are the potential side effects?
While specific side effects are not listed here, auricular VNS is generally considered low-risk. Potential side effects might include discomfort at the stimulation site or changes in heart rate or blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had a bleeding in the space around my brain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am on medication to suppress my immune system for another illness.
Select...
I am currently receiving chemotherapy.
Select...
I have bleeding in my brain caused by an injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in inflammatory markers in the CSF on admission
Change in inflammatory markers in the serum
Inflammatory markers in the CSF on admission
+1 more
Secondary study objectives
Cerebral Infarction
Cerebral vasospasm
Clinical outcome
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Auricular VNS StimulationExperimental Treatment1 Intervention
Participants receive twice daily auricular vagal nerve stimulation
Group II: Sham Auricular VNS StimulationPlacebo Group1 Intervention
Participants will have an auricular vagal nerve stimulator applied twice daily, without the stimulation applied
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Auricular Vagus Nerve Stimulation
2022
N/A
~60

Find a Location

Who is running the clinical trial?

Anna HuguenardLead Sponsor
Eric C Leuthardt, MDPrincipal InvestigatorWashington University School of Medicine

Media Library

Auricular Vagus Nerve Stimulation (Vagus Nerve Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04557618 — N/A
Subarachnoid Hemorrhage Research Study Groups: Sham Auricular VNS Stimulation, Auricular VNS Stimulation
Subarachnoid Hemorrhage Clinical Trial 2023: Auricular Vagus Nerve Stimulation Highlights & Side Effects. Trial Name: NCT04557618 — N/A
Auricular Vagus Nerve Stimulation (Vagus Nerve Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04557618 — N/A
~0 spots leftby Dec 2024
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