Digital Biomarkers for Objectively and Remotely Monitoring Migraine

Overview

About this study

Changes in vision are commonly reported by patients during migraine attacks. Even in patients that do not report changes in vision, we have noted objective changes as demonstrated by changes in the King-Devick Test (KDT), a quantitative measure of rapid eye movement; which was 6.5 seconds slower (SD 7.6 seconds, p<0.001) during a migraine attack compared to between migraine attacks. This study aims to evaluate changes in timed rapid number naming using the KDT during the twelve hours prior to a migraine attack (“pre-attack” phase) and during the migraine attack compared to the between attack phase. Accurate prediction of an impending migraine attack based on changes in the KDT would allow for future studies that determine the effectiveness of proactively treating migraine attacks during the very early “pre-symptomatic” stage, a strategy that would likely provide superior outcomes compared to current standard-of-care.

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:

  1. 18 years of age or older
  2. Migraine with or without aura diagnosed according to ICHD3 diagnostic criteria
  3. 4-10 migraine attacks per month (average over the prior 3 months)
  4. Fewer than 15 headache days per month (average over the prior 3 months)
  5. Willing to provide KDT samples 3 times per day
  6. Willing to maintain a daily headache diary

 

Exclusion Criteria:

  1. Greater than 10 migraine attacks per month (average over the prior 3 months)
  2. 15 or greater headache days per month (average over the prior 3 months)
  3. Baseline ocular conditions
  4. Other neurologic diseases or history of intracranial surgery
  5. History of concussion within past 2 years

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

Juliana VanderPluym, M.D.

Closed for enrollment

Contact information:

Juliana VanderPluym M.D.

(480)301-9443

VanderPluym.Juliana@mayo.edu

More information

Publications

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Study Results Summary

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Supplemental Study Information

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