Overview
The purpose of this study is to assess the effectiveness of using remote electrical neuromodulation, using the Nerivio ® device, to relieve pain associated with receiving onabotulinumtoxinA (Botox) injections for chronic migraine prevention.
Eligibility
Inclusion Criteria:
- Meet the criteria for 1.3 chronic migraine based on ICHD3 criteria.
- Currently receiving onabotulinumtoxinA per PREEMPT protocol for the treatment of chronic migraine.
- Have remained stable on their current headache medication for a minimum of 8 weeks.
- Patient is willing and able to comply with the protocol to the satisfaction of the investigator.
- Patient has the capacity to provide written, informed consent for themselves.
Exclusion Criteria:
- Participants with an active implanted electrical and/or neurostimulator device (e.g., cardiac pacemaker, cochlear implant).
- Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
- Participants with uncontrolled epilepsy.
- Change in migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the study.
- Pregnant, trying to get pregnant or breastfeeding female participants.
- Subjects participating in any other interventional clinical study.
- Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments.
- Participants who have previous experience with the device.
- Patients with cranial deformities, prior cranial surgeries with violation of the calvarium, or shunt placement.