Health TrialsbyHealthPanel

Auricular VNS Following Intracerebral Hemorrhage

ConditionIntracerebral Hemorrhage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients who present with a spontaneous supratentorial intracerebral hemorrhage (ICH) to Barnes Jewish Hospital

Disqualifiers

Patients < 18 years old

Patients with a presumed traumatic etiology for their ICH, infratentorial location, ICH volume > 60 ml or < 10 ml, at risk of imminent death (e.g. Glasgow Coma Scale, GCS of 3 or one or more pupils unreactive), surgical intervention imminently planned (not including ventriculostomy)

Patients undergoing active cancer therapy

Patients with sustained bradycardia on arrival with a heart rate < 50 beats per minute.

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

80 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

Change in the inflammatory marker IL-6 in plasma

Blood samples collected on days 1, 4, 7, 10, and 14 (Day 1 serves as baseline, prior to first treatment). Inflammatory markers will be reported in pg/mL.

Time frame
14 days
2

Growth of perihematomal edema

Change in edema extension distance (baseline vs. peak) will be compared between groups, via quantitative assessment of serial computed tomography (CT) scans obtained on day 1, 4, 7, 10, and 14 (Day 1 serves as baseline, prior to first treatment).

Time frame
14 days
3

Neurological worsening

Occurrence of clinical deterioration due to edema by criteria of 1) a reduction in GCS by 2 points or greater that persists for at least one hour, 2) worsening focal neurological deficits (NIHSS increase by at least 4 points), excluding other causes, or 3) need for surgical intervention or medical treatments for edema (osmotic therapies).

Time frame
Through hospital admission, average 14 days

Secondary outcomes

1

Change in additional inflammatory markers in plasma

Blood samples collected on days 1, 4, 7, 10, and 14 to evaluate for IL-1b, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-17a, GM-CSF, IFN gamma, and TNF-α. Inflammatory markers will be reported in pg/mL.

Time frame
14 days
2

Change in inflammatory markers in cerebrospinal fluid

Cerebrospinal fluid samples collected on days 1, 4, 7, 10, and 14 to evaluate for IL-1b, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-17a, GM-CSF, IFN gamma, and TNF-α. Inflammatory markers will be reported in pg/mL.

Time frame
14 days
3

Relative perihematomal edema

Relative perihematomal edema volume, the ratio of perihematoma volume to intracerebral hematoma volume

Time frame
14 days
4

Neurological outcome

Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Washington University School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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