Wearable Devices to Predict and Track Chronic Migraine Clinical Outcomes

Overview

About this study

The purpose of this study is to accurately track biomarkers of headache coupled with patient reporting of severity with minimal effort by the patient using a custom phone app integrating patient and devices. Also, to accurately forecast periods of increased headache likelihood to allow patients earlier and more effective treatments.

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:

  • Age 18 years and older (no upper age limit defined).
  • History of chronic migraine as defined by the International Headache Society’s International Classification of Headache Disorders (3rd edition)8.
  • Receiving onabotulinum toxin A injections following a PREEMPT protocol for treatment of chronic migraine for ≥ 1 year.
  • Response to therapy with onabotulinum toxin A injections of ≥ 50% improvement in the frequency of headache days when compared to baseline.
  • 4 to 14 average number of total headaches days per month during peak efficacy of onabotulinum toxin A injections.
  • Ability to understand study procedures and to comply with them for the entire length of the study and use study devices as outlined in protocol.
  • Patient agrees to maintain a daily electronic headache diary.
  • Proficient in the use of electronic devices including Apple HomeKit and Apple Watch. Subjects owns an iPhone 6s or later with iOS 15 or later operating system installed on iPhone. Apple watch with watch OS6 will be provided by the study.
  • Women of childbearing potential shall either be surgically sterile or must agree not to become pregnant for the duration of the study. Subjects of childbearing potential must agree to use a medically approved form of birth control (abstinence, intrauterine device (IUD), oral contraception, barrier and spermicide or hormonal implant) throughout the duration of the study.
  • If female, the subject may not be pregnant or breastfeeding. As per routine clinical care, patients who become pregnant while receiving onabotulinum toxin A injections will stop receiving the injections and detection of pregnancy will be guided by routine clinical practice.

Exclusion Criteria: 

  • Chronic daily headache with no periods of headache freedom.
  • ≥ 15 average number of headaches days per month during peak efficacy of onabotulinum toxin A injections.
  • Medication overuse headache as defined by the International Headache Society’s International Classification of Headache Disorders (3rd edition)8.
  • Daily opioid use for > 3 months (e.g., hydrocodone, oxycodone, fentanyl patch) or other daily analgesic use for chronic pain disorders (e.g., NSAIDS or acetaminophen).
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/27/22. 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

Rochester, Minn.

Mayo Clinic principal investigator

Narayan Kissoon, M.D.

Open for enrollment

Contact information:

Julianna Ethridge

(507) 284-1686

Ethridge.Julianna@mayo.edu

More information

Publications

Publications are currently not available