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Auricular VNS Following Subarachnoid Hemorrhage

ConditionSubarachnoid Hemorrhage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnna Huguenard

About this trial

This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following spontaneous subarachnoid hemorrhage.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Spontaneous subarachnoid hemorrhage

Disqualifiers

Trauma-induced subarachnoid hemorrhage

Ongoing chemotherapy

Taking immunosuppressive medications for other medical illnesses

Presence of a pacemaker

Trial design

Design model

Parallel

Treatments tested in this trial

  • Auricular Vagus Nerve Stimulation

    Device

    Transcutaneous auricular vagal nerve stimulation

  • Sham Auricular Vagus nerve Stimulation

    Device

    Transcutaneous auricular vagal nerve ear clip applied without current

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Auricular VNS StimulationExperimental treatment 1 intervention
Group B: Sham Auricular VNS StimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Inflammatory markers in the serum on admission

TNF alpha from blood draw

Time frame
On hospital day 1
2

Change in inflammatory markers in the serum

TNF alpha from blood draws

Time frame
Through hospital admission, average of 4 weeks
3

Inflammatory markers in the CSF on admission

TNF alpha from cerebrospinal fluid

Time frame
On hospital day 1
4

Change in inflammatory markers in the CSF

TNF alpha from cerebrospinal fluid

Time frame
Through hospital admission, average of 4 weeks

Secondary outcomes

1

Inflammatory markers in the serum on admission

IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8from blood draws

Time frame
On hospital day 1
2

Change in inflammatory markers in the serum

IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8 from blood draws

Time frame
Through hospital admission, average of 4 weeks
3

Inflammatory markers in the CSF on admission

IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8, from cerebrospinal fluid

Time frame
On hospital day 1
4

Change in inflammatory markers in the CSF

IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8, from cerebrospinal fluid

Time frame
Through hospital admission, average of 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anna Huguenard

Lead sponsor

Washington University School of Medicine

Sponsor institution

Source ClinicalTrials.gov
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