Migraine DisordersMigraineNCT03762902
Predicting Migraine Attacks Based on Environmental and Behavioral Changes as Detected From the Smartphone
An observational study of Migraine Disorders and Headache Disorders, run by Lifegraph Ltd. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Migraine Disorders, Headache Disorders, Headache Disorders, Primary
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Apr 2019to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who suffer from episodic migraine
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Henry Ford Health System Main Campus
Detroit, Michigan, 48202
Henry Ford Health System
West Bloomfield, Michigan, 48322
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Migraine Disorders, Headache Disorders, Headache Disorders, Primary, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Alzheimer Disease, Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing Lifegraph's predictive ability of migraine attacks before subjects report they experience an attack.
Lifegraph has created a scalable and dynamic platform to accommodate different conditions, different types of patients with different types of data, concurrently. This platform converts the raw sensor data accumulating in Lifegraph's servers into behavioral and environmental features that have been found to be informative and helpful in generating insights relevant to migraines. The features are fed into machine learning algorithms that search for early signs of change, that may indicate an oncoming attack. These algorithms may be divided into population-based and personalized models. The study will develop a separate predictive model for each subject to predict the probability of experiencing a migraine attack during a particular interval (e.g. the next 12, 24, or 48 hours). Higher precision values of prediction will represent a better outcome. The precision is expected to be 50-70%, depends on the time passed since first installing the app and the number of reported migraine attacks
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start30 Apr 2019
- Primary completion1 Aug 2019
- Study completion1 Sep 2019
Why it stopped: Sufficient data was collected through the app to achieve initial results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifegraph Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Henry Ford Health System
- Responsible party
- Sponsor
- Investigators
- Ashhar Ali, DO, Principal investigator, Senior Staff Physician, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762902
- Sponsor's protocol ID
- LifegraphMigrainePrediction
- Acronym
- Migraine
- Status last verified
- May 2019
- First submitted
- 30 Nov 2018
- Last updated
- 13 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Analyzed Sensory Data of the Smartphone and Migraine Attacks, Recorded by Individuals Who Suffer From Episodic Migraine
- ClinicalTrials.gov ID
- NCT03762902
- Acronym / sponsor ID
- Migraine / LifegraphMigrainePrediction
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sufficient data was collected through the app to achieve initial results
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Lifegraph Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Henry Ford Health System
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who suffer from episodic migraine
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessing Lifegraph's predictive ability of migraine attacks before subjects report they experience an attack.
Time frame: 3 months
Lifegraph has created a scalable and dynamic platform to accommodate different conditions, different types of patients with different types of data, concurrently. This platform converts the raw sensor data accumulating in Lifegraph's servers into behavioral and environmental features that have been found to be informative and helpful in generating insights relevant to migraines. The features are fed into machine learning algorithms that search for early signs of change, that may indicate an oncoming attack. These algorithms may be divided into population-based and personalized models. The study will develop a separate predictive model for each subject to predict the probability of experiencing a migraine attack during a particular interval (e.g. the next 12, 24, or 48 hours). Higher precision values of prediction will represent a better outcome. The precision is expected to be 50-70%, depends on the time passed since first installing the app and the number of reported migraine attacks
Results and safety
The study was stopped early (reason given: Sufficient data was collected through the app to achieve initial results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashhar Ali, DO principal investigator
Senior Staff Physician, Department of Neurology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders and Headache Disorders, run by Lifegraph Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sufficient data was collected through the app to achieve initial results). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing Lifegraph's predictive ability of migraine attacks before subjects report they experience an attack. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.