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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: No
View:

• Established signed and dated informed consent form

• CT of the head revealing blood in the subarachnoid space

• Subject is male or female, 18 to 80 years of age

• Subject alert to be able to verbalize pain level. If alertness improves after placement of an external ventricular drain, or once extubated, and the patient becomes alert , the patient will be enrolled

• Subject reports pain of > =7 on 10 Point Pain numeric rating scale

• Female of reproductive age must have a negative pregnancy test (Urine or blood test)

Locations
United States
New York
Northshore University Hospital
Recruiting
Manhasset
Contact Information
Primary
tania rebeiz, MD
trebeiz@northwell.edu
9176734908
Backup
Betsy Moclair, RN
bmoclaire@northwell.edu
5162537753
Time Frame
Start Date: January 13, 2020
Estimated Completion Date: May 30, 2022
Participants
Target number of participants: 40
Treatments
Sham Comparator: Sham arm
gammaCore sham device which will not provide stimulation of the vagus nerve
Active Comparator: Treatment group
Active gammaCore device that supplies non-invasive stimulation of the cervical branch of the Vagus nerve
Sponsors
Leads: Northwell Health

This content was sourced from clinicaltrials.gov

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