Safety and Efficacy of Non-invasive Vagus Nerve Stimulation in the Treatment of Headache in Subarachnoid Hemorrhage
Condition: Subarachnoid Hemorrhage, Aneurysmal
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage; Headache
Study type: Interventional

Summary: 
      This is a single site, randomized, sham-controlled, double blinded pilot study assessing the
      feasibility, safety, tolerability, and efficacy of non-invasive VNS (nVNS), gammaCore, in the
      treatment of headache in subarachnoid hemorrhage (SAH). 40 participants will be enrolled, 20
      in the active device arm and 20 in the sham arm. The primary efficacy outcome is the the
      difference between the active and sham treatment groups in morphine equivalence dosage.
    

Detailed description: 
      This is a single site, randomized, sham-controlled, double-blind study assessing the
      feasibility, safety, tolerability, and efficacy of non-invasive VNS (nVNS) in the treatment
      of headache in subarachnoid hemorrhage (SAH). The hypothesis is that two-two minute
      noninvasive stimulations of the cervical branch of the Vagus nerve, every 5 hours, is
      efficacious in safely reducing headache intensity and frequency in patients with headache due
      to SAH, during the patient's intensive care unit (ICU) stay. After screening and obtaining
      informed consent, eligible patients diagnosed with SAH on head scans, admitted to the
      Neurosurgical Intensive Care Unit (NSCU) at Northshore University Hospital will be randomized
      to either the treatment (stimulation of the cervical branch of the Vagus nerve) or sham
      (inactive stimulation) group. Pain intensity will be evaluated every 4 hours. Non-invasive
      stimulation will be performed every 5 hours. Device related adverse events, mean headache
      intensity, and mean and peak morphine equivalence dosage during the study period will be
      compared between the VNS group and the sham group.

      The primary objective of this study is to examine the safety and effectiveness of nVNS as a
      treatment for headache in subarachnoid hemorrhage (SAH).

      The primary safety endpoint for this study is the incidence of device related serious adverse
      events.

      The primary outcome measurements for effectiveness is the difference between the active and
      sham treatment groups in morphine equivalence dosage

      Secondary endpoints include descriptive comparisons between the active and sham treatment
      groups in:

        -  The difference between the active and sham treatment groups in the mean daily headache
           intensity

        -  The difference between total overall morphine equivalence dosage between the active and
           sham group per subject during study

        -  Opiate related adverse events (such as urinary retention, constipation, sedation,
           respiratory depression, nausea, vomiting and pruritis)

        -  The difference in CSF and blood inflammatory markers before and after VNS

        -  Difference in vessel diameter during angiogram for cerebral vasospasm before and after
           VNS

      Study period is 14 days starting 24-72 hours post successful treatment of the aneurysm and
      extubation.
    

Intervention name(s): gammaCore
Intervention type(s): Device
Intervention description(s): The intervention consists of a transcutaneous non-invasive stimulation of the cervical branch of the vagus nerve (nVNS) using gammaCore, an FDA approved device for the treatment of migraine and cluster headache. This will be compared to the sham device, which is the same device which will not provide stimulation to the nerve. Stimulation frequency will be identical to the frequency used in previous nVNS studies for the treatment of migraine headache.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment