← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

0 / 1Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial open for enrollment at present?

"As per the clinicaltrials.gov database, this clinical trial is accepting participants and has been since it was first posted on November 12th 2020. The listing's data was last refreshed on November 30th 2021."

Answered by AI

What aims is this investigation attempting to achieve?

"The primary aim of this study, to be evaluated on hospital day 1, is assessing inflammatory markers in the cerebrospinal fluid. Secondary objectives include determining if stressed-induced cardiomyopathy has occurred by evaluating new troponin elevation, EKG changes (namely ST segment elevation/depression, left bundle branch block and prolonged QT interval), and echocardiogram findings; verifying cerebral ischemia with radiographic evidence of a new infarct or stroke; as well as utilizing Modified Rankin Scale for Neurological Disability (ranging from 0 - 6) to measure clinical outcomes."

Answered by AI

How many participants are currently enrolled in this clinical trial?

"Affirmative. According to clinicaltrials.gov, the trial is actively seeking volunteers that meet its inclusion criteria since it was first posted on November 12th 2020 and last updated on November 30th 2021. A total of 80 participants are required for this single-site medical experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Auricular VNS Following Subarachnoid Hemorrhage

Anna Huguenard 2021. "Auricular VNS Following Subarachnoid Hemorrhage". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04557618.

All > Sah