Non-Invasive Neurostimulation For the Relief of Symptoms Associated With Migraine

Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device For the Relief of Symptoms Associated With Migraine

The purpose of this pilot study is to assess feasibility and clarify the design of future study(ies) to support marketing approval of the GammaCore™ device for the treatment and/or prevention of migraine symptoms.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Device: n-VNS

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF Headache Center
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Headache Center
    • New York, New York, United States, 10021
      • New York Headache Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Is between the ages of 18 and 55 years.
• Has been previously diagnosed as suffering from migraine, in accordance with the ICHD-2 Classification criteria (2nd), with or without aura.
• Experiences at least 2 migraines per month, but less than 15 headache days per month (over the last 3 months).
• Has age of onset of migraine less than 50 years old.
• Is able to give written Informed Consent

Exclusion Criteria:

• Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
• Has a lesion (including lymphadenopathy) at the GammaCore™ treatment site.
• Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), coronary artery disease or recent myocardial infarction.
• Has a history or baseline ECG that identifies the presence of a clinically significant unstable cardiac arrhythmia, second degree heart block type II, history of ventricular tachycardia or ventricular fibrillation, or known cardiac syndromes that may be associated with increased risk of sudden death in otherwise healthy people.
• Has had a previous bilateral or right cervical vagotomy.
• Has a clinically significant irregular heart rate or rhythm.
• Has uncontrolled high blood pressure.
• Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
• Has a history of carotid endarterectomy or vascular neck surgery on the right side.
• Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore™ stimulation site.
• Has a recent or repeated history of syncope.
• Has a recent or repeated history of seizure.
• Has a history or suspicion of narcotic abuse.
• Takes medication for acute headaches more than 10 days per month.
• Is pregnant, nursing, thinking of becoming pregnant in the next 3 months, or of childbearing years and is unwilling to use an accepted form of birth control.
• Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
• Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner).
• Is a relative of or an employee of the investigator or the clinical study site.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active; n-VNS active therapy	Device: n-VNS; Other Names: gammaCore

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Number of Participants With Adverse Effects	The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated.	End of Study - 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Headache Pain From Baseline to 120 Minutes	Headache was measured on a 4 point scale where 0 = no pain, 1 = mild, 2 = moderate, 3 = severe pain at baseline (start of attack), 5, 15, 30, 45, 60, 90 and 120 minutes. Data presented shows the average change from baseline to 120 minutes	120 minutes
Change in Photophobia (Visual) From Baseline to 120 Minutes	Presence of photophobia (yes or no) was captured at baseline and 120 minutes.	Base line and 120 minutes
Change in Phonophobia (Auditory) From Baseline to 120 Minutes	Presence of phonophobia (yes or no) was captured at baseline and 120 minutes.	Baseline and 120 minutes
Mean Change in Nausea From Baseline to 120 Minutes	Nausea was captured in the diary and measured on a 4 point scale, where 0 = no nausea, 1 = mild, 2 = moderate and 3 = severe nausea, at baseline and 120 minutes.	Baseline 120 minutes
Mean Change in Functional Disability	Functional disability was captured in the diary and measured on a 4 point scale, where 0 = no disability, able to function normally and where 3 = performance of daily activities severely impaired, measured at baseline and 120 minutes.	Baseline and 120 minutes

Collaborators and Investigators

• Sponsor: ElectroCore INC

Publications and helpful links

General Publications

• Goadsby PJ, Grosberg BM, Mauskop A, Cady R, Simmons KA. Effect of noninvasive vagus nerve stimulation on acute migraine: an open-label pilot study. Cephalalgia. 2014 Oct;34(12):986-93. doi: 10.1177/0333102414524494. Epub 2014 Mar 7.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2012
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): July 25, 2012

Study Registration Dates

• First Submitted: February 10, 2012
• First Submitted That Met QC Criteria: February 10, 2012
• First Posted (ESTIMATE): February 15, 2012

Study Record Updates

• Last Update Posted (ACTUAL): July 10, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: migraine; vagus nerve stimulation; VNS; vagal nerve stimulation; nVNS; non invasive; gammacore
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: M-US-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO