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

Study Overview
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Brief Summary
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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.

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

Conditions
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Migraine

Intervention / Treatment
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* Device: n-VNS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>n-VNS active therapy | Device: n-VNS<br> <br> * Other names: gammaCore;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vagus nerve stimulation, vagal nerve stimulation, nVNS, migraine, non invasive, gammacore, VNS