Acute Procedural Pain Treated With Remote Electrical Neuromodulation in Chronic Migraine Patients Receiving Onabotulinumtoxina
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 22-011180
NCT ID: NCT05730556
About this study
The purpose of this study is to evaluate the effectiveness of remote electrical neuromodulation with Nerivio ® (Theranica Bio-electronics, Ltd.) for treatment of acute procedural pain in patients receiving onabotulinumtoxinA for the treatment of chronic migraine.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adults aged 18 to 75 years old.
- 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.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 10/11/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Amaal Starling, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available