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