Individualized Prediction of Migraine Attacks Using a Mobile Phone App and Fitbit

Completed

Conditions studied: Migraine Disorders, Headache Disorders, Primary, Headache Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases

In brief

This trial is collaboration between Mayo Clinic, Second Opinion Health (Simon Bloch, simon@somobilehealth.com 408-981-3814) and Allergan. Mayo Clinic investigators are conducting the clinical trial, Second Opinion Health is providing the software for use in the trial (Migraine Alert app for data collection, analysis and machine learning algorithms), and Allergan is providing funding. The investigators hypothesize that the use of a mobile phone app and Fitbit wearable to collect daily headache diary data, exposure/trigger data and physiologic data will predict the occurrence of migraine attacks with high accuracy. The objective of the trial is to assess the ability to use daily exposure/trigger and symptom data, as well as physiologic data (collected by Fitbit) to create individual predictive migraine models to accurately predict migraine attacks in individual patients via a mobile phone app.

Key facts

Study ID

NCT02910921

Run by

Second Opinion Health

People needed

19

Starts

2016-11-01

Expected to finish

2018-07-31

Last updated by the study team

2018-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects fulfilling ICHD-3beta criteria for migraine with average of 5 - 10 migraine attacks per month and up to 12 headache days per month
• Males of females 18 years of age or older
• Subject report of weather being one of the triggers
• Subject has an iPhone
• Subject is willing to wear a Fitbit device for the duration of the study
• Subject has an active Facebook account or is willing to create one

You may not qualify if…

• Children younger than 18 years of age
• Subjects with headaches other than migraine or probable migraine
• Inability to provide informed consent
• Not willing to maintain a daily diary
• Current participation in another clinical trial

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• University of Southern California — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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