NCT04126408

Safety and Efficacy of Non-invasive Vagus Nerve Stimulation in the Treatment of Headache in Subarachnoid Hemorrhage

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Subarachnoid Hemorrhage, Aneurysmal

Interventions

Type	Name	Description
DEVICE	gammaCore	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.

Timeline

• Start date: 2020-01-13
• Primary completion: 2022-06-20
• Completion: 2022-06-20
• First posted: 2019-10-15
• Last updated: 2024-01-09
• Results posted: 2024-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study