Migraine Disorders Clinical Trial
Official title:
The Relation Between Analyzed Sensory Data of the Smartphone and Migraine Attacks, Recorded by Individuals Who Suffer From Episodic Migraine
This study is conducted at the Henry Ford Health System with Lifegraph's behavioral monitoring technology, to examine the relation between migraine attacks and behavioral and environmental changes as detected from the smartphone sensors. The investigators hypothesize that Lifegraph's technology can predict the occurrence of migraine attacks with high precision.
Migraine attacks can damage quality of life and lead to missed work days if not treated in
time. These attacks last for about 4-72 hours, accompanied by headache and other symptoms.
The time window for early intervention, which can potentially reduce the severity of an
attack, lasts 2-48 hours before symptoms are starting to appear (10 hours on average). This
time window is defined in the literature as the prodromal phase, when intervention during
this phase can allow early treatment to improve the patient's condition and reduce the
intensity and duration of the attack.
Migraine attacks and the prodromal phase can be characterized by one or more behavioral or
environmental symptoms, either causal or resultant. Some of them can be passively measured by
the smartphone usage, such as changes in sleep, physical activity and weather.
Lifegraph's smartphone application runs in the background of the subjects' personal
smartphone, collects data passively and automatically, while rigorously maintaining privacy
and with no effect to the daily use. Proprietary machine-learning algorithms analyze the
collected data and turn it into behavioral channels, such as activity, sleep and mobility.
The technology learns the personal routine of each user and detects changes in his/her
behavioral patterns that can indicate an upcoming migraine.
Eligible subjects will meet a neurologist, sign an informed consent, fill an initial
questionnaire and install the Lifegraph application on their smartphone. The application
requires a one-time registration process.
During the study, subjects will self-report migraine attacks they experience through the
smartphone application. Each report will include start time, end time and pain intensity.
Data will be analyzed during the study in order to learn each subject's behavior and his/her
migraine attacks. Subjects will be blinded to the app's migraine predictions to avoid
expectancy bias.
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