Non-Invasive Neurostimulation for the Prevention of Chronic Migraine
Non-Invasive Neurostimulation for the Prevention of Chronic Migraine
The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled
 pilot study is to study feasibility and collect preliminary clinical data related to the
 safety and clinical benefits of daily use of non-invasive vagal nerve stimulation with the
 GammaCore device for the prevention of chronic migraine, and to support the development and
 approval of a larger pivotal study.
Inclusion Criteria:

 -  Is between the ages of 18 and 65 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 15 headache days per month (over the last 3 months).

 -  Has age of onset of migraine less than 50 years old.

 -  Agrees not to use any migraine prevention treatments (including Botox injections)
 and/or medications (exclusive of medications taken for acute relief of migraine
 symptoms).

 -  Is able to provide written Informed Consent

 -  Agrees to refrain from changing the type or dosage of any prophylactic medications for
 indications other than chronic migraine that in the opinion of the clinician may
 interfere with the study

 Exclusion Criteria:

 -  Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head
 trauma.

 -  Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal
 anatomy 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),
 known severe coronary artery disease or recent myocardial infarction.

 -  Has an abnormal baseline ECG (e.g. second and third degree heart block, atrial
 fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular
 fibrillation, or clinically significant premature ventricular contraction)

 -  Has had a previous bilateral, right, or left cervical vagotomy.

 -  Has uncontrolled high blood pressure.

 -  Is currently implanted with an electrical and/or neurostimulator device, including but
 not limited to cardiac pacemaker or defibrillator, 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 known history or suspicion of substance abuse or addiction.

 -  Has had a surgery for migraine prevention.

 -  Has received Botox injections for migraine prevention within the past 6 months.

 -  Has taken medications for migraine prophylaxis in the previous 30 days.

 -  In the opinion of the investigator/research staff the subject is incapable of
 operating the GammaCore device as intended and performing the data collection
 procedures.

 -  Is pregnant, nursing, thinking of becoming pregnant in the next 9 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.