Acute Procedural Pain Treated With Remote Electrical Neuromodulation in Chronic Migraine Patients Receiving Onabotulinumtoxina

Overview

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 Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Amaal Starling, M.D.

Open for enrollment

Contact information:

Hannah Henderson M.A.

(480) 301-6091

Henderson.Hannah2@mayo.edu

More information

Publications

Publications are currently not available