Non-invasive Neurostimulation for the Relief of Migraine

Exclusion Criteria

• •Has a history of aneurysm, bleed, brain tumors or significant head trauma.
• •Has a lesion (including lymphadenopathy) at the therapy head placement site.
• •Has known or suspected severe atherosclerotic cardiovascular disease, carotid artery disease (e.g. bruits or history of TIA or CVA) or congestive heart failure (CHF).
• •Has a history of epilepsy.
• •Has suspected or confirmed sepsis, or infection.
• •Has a clinically significant irregular heart rate or rhythm.
• •Is receiving pressors to maintain blood pressure.
• •Has a history of syncope.
• •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 been implanted with metal cervical spine hardware.
• •Has a history of carotid endarterectomy or vascular neck surgery on the right side.
• •Has a condition that would interfere with headache pain self-assessment.
• •Is pregnant or is thinking of becoming pregnant in the next 6 weeks.
• •Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
• •Takes medication for acute headaches more than 10 days per month.
• •Has a history or suspicion of substance abuse
• •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).