Clinical trial NCT03762902: Predicting Migraine Attacks Based on Environmental and Behavioral Changes as Detected From the Smartphone
Official title: The Relation Between Analyzed Sensory Data of the Smartphone and Migraine Attacks, Recorded by Individuals Who Suffer From Episodic Migraine
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Migraine Disorders
Headache Disorders
Headache Disorders, Primary
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Keywords: Migraine
Smartphone
App
Prediction
Forecast
Detection
Individual
Machine Learning
Data Science
Algorithm
Behavior
Henry Ford Health System
HFHS
Lifegraph
Lead sponsor: Lifegraph Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Henry Ford Health System
First posted: 2018-12-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who suffer from episodic migraine

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Individuals who suffer from episodic migraine with 4-14 days of migraine per month (ICHD-3 patients).
* Individuals who possess a smartphone - Android version 5.0 and above or iOS version 10.0 and above.

Exclusion Criteria:

* Individuals who are unable to sign the consent form.
* Pregnant women.
* Individuals suffering from headaches that do not meet the IHS migraine criteria or don't have moderate to severe chronic pain of VAS chronic grade 4 and above.

Primary outcomes:
measure: Assessing Lifegraph's predictive ability of migraine attacks before subjects report they experience an attack.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System Main Campus
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Senior Staff Physician, Department of Neurology
name: Ashhar Ali, DO
role: PRINCIPAL_INVESTIGATOR
References: