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

January 6, 2024 updated by: Tania Rebeiz, Northwell Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Manhasset, New York, United States, 11030
        • Northshore University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Use of any concomitant electrostimulation devices (Pacemaker, defibrillator, deep brain stimulation.)
  • Unsecured aneurysm defined as aneurysm that has not been surgically or endovascularly treated.
  • Previous carotid surgeries or known history of carotid artery disease
  • Screws, metals or device in the neck
  • History of secondary or tertiary heart blocks, ventricular tachycardia, Supra-Ventricular Tachycardia (including atrial fibrillation)
  • Alcoholics (CAGE scale of 2 or greater). If patients are on Clinical Institute Withdrawal Assessment for Alcohol (CIWA) protocol for alcohol withdrawal, the patient will be excluded from the study.
  • Drug addicts or chronic opioid users confirmed by history or with urine toxicology showing opiates or cocaine
  • small traumatic SAH

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham arm
gammaCore sham device which will not provide stimulation of the vagus nerve
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.
Active Comparator: Treatment group
Active gammaCore device that supplies non-invasive stimulation of the cervical branch of the Vagus nerve
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Difference Between the Active and Sham Treatment Groups in Morphine Equivalence Dosage PER DAY
Time Frame: up to 14 days of admission
Daily morphine equivalence dosage will be calculated and compared between the active and Sham group
up to 14 days of admission
Overall Difference in MED at 7 Days
Time Frame: baseline and 7 days
difference in mean morphine equivalent dosage at 7 days between active and sham group
baseline and 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Difference Between the Active and Sham Treatment Groups in the Mean Daily Headache Intensity Pre and Post Stimulation
Time Frame: up to 14 days of admission
Headache intensity is measured every 4 hours per standard of care. The pain intensity is reported using a 0 to 10 numeric rating scale, o being no pain, and 10 being severe pain. least mean square difference between the 2 groups between the pre and post stimulation pain score
up to 14 days of admission
The Difference in Device Related Heart Rate Change Before and After Stimulation
Time Frame: up to 14 days of admission
difference in change in Heart rate between the 2 groups from before to after stimulation
up to 14 days of admission
Change in SBP Between Active and Sham Group
Time Frame: before and after stimulation, up to 14 days
difference between pre and post stimulation SBP between the 2 groups
before and after stimulation, up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2020

Primary Completion (Actual)

June 20, 2022

Study Completion (Actual)

June 20, 2022

Study Registration Dates

First Submitted

September 13, 2019

First Submitted That Met QC Criteria

October 13, 2019

First Posted (Actual)

October 15, 2019

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 6, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-0837

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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