ClinicalTrials.gg
CompletedNCT02910921Migraine AlertUpdated Aug 6, 2018

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

An observational study in Migraine Disorders, Headache Disorders, Primary and Headache Disorders, sponsored by Second Opinion Health. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-06.

Sponsored by Second Opinion Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
19
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Eliminating migraine attacks before they start is of an enormous importance to migraine sufferers. But figuring out the onset of an attack before it actually starts remains a major challenge for the medical community.

The widespread use of mobile smartphones, the availability of wearable devices that measure health information, and advances in multivariate pattern analysis via machine learning algorithms allow for development of individual predictive models that can determine the likelihood of an individual patient developing a migraine on a given day. Such models are based upon objectively measured biometric parameters (e.g. activity, sleep), objectively measured environmental conditions (e.g. weather parameters), exposures to possible migraine triggers, and patient reported symptoms. Using machine-learning algorithms to explore this large dataset that is collected for each patient, the optimal combination of factors that most accurately predict the likelihood of a migraine attack is determined.

Prediction of individual migraine attacks would have substantial positive impacts for patients with migraine. Accurate prediction of a migraine attack would give the migraineur a greater sense of control over their condition, a sense of control that is often lacking in patients with migraine. Most importantly, if individual migraine attacks could be predicted with high accuracy, treatment of that inevitable migraine attack before development of symptoms could prevent the attack altogether.

Eligible subjects will enter a baseline phase during which subjects will wear a Fitbit device and record data into the daily headache diary using the mobile phone app. This phase will be of variable duration for each subject to a maximum of 75 days. It is during the baseline phase that the individualized predictive model for a migraine attack is developed and optimized.

During the second phase (75 days), the accuracy of the predictive model will be tested. The probability of developing a migraine will be calculated and the accuracy of the prediction will be tested against the patient reported incidence of migraine attacks within the mobile phone app. Subjects will be blinded to the app's migraine attack predictions to avoid expectancy bias.

Migraine prediction suffers from 'the curse of dimensionality' (machine learning parlance). Too many factors affect outcomes, but the outcomes (positive migraine attacks) are few and far in between. To develop an accurate machine learning model using traditional approaches requires a long and impractical time duration. Migraine Alert has effectively addressed these using proprietary algorithms and techniques that generate individual models using fewer migraines. Covariate analysis is performed for each individual using features derived from the raw data. Individual models may differ from one other in the specific feature they use and/or the importance attached to them in the model. Proprietary techniques are used to create these individual models and to monitor their pre-validation and post-validation accuracy and recall. Concept drift as evidenced by any degradation in accuracy or recall is monitored in the prediction phase and model is retrained as necessary.

02

Conditions studied

  • Migraine Disorders
  • Headache Disorders, Primary
  • Headache Disorders
  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases

Keywords

  • Migraine
  • Prediction
  • Forecast
  • App
  • Fitbit
  • Individual
  • Algorithm
  • Machine Learning
  • Mayo Clinic
  • Allergan
  • Second Opinion
03

In context

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

This study's enrollment of 19 is below the median of 137 across 331 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

This is the only study on the registry with Second Opinion Health as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

People with episodic migraines

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Children younger than 18 years of age
  • Subjects with headaches other than migraine or probable migraine
  • Inability to provide
  • Not willing to maintain a daily diary
  • Current participation in another clinical trial
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
19 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. AUC of individual prediction models using cross validation data on environmental and physiological variables.

    The study will develop a separate predictive model for each participant that will forecast probability of experiencing a migraine attack during a particular interval. The outcome measures performance of this model using the Area Under the Curve (AUC) metric. AUC measures how often the algorithm predicts a higher probability for a migraine over non-migraine. This measure is attractive because it is independent of the quantization threshold, which is required for other metrices such as precision/recall. In the baseline phase, 30% of the data will be randomly selected for cross validation and will not used for training the model. Once the model is trained, the AUC of the model is measured on the cross validation data as the outcome of this phase. The data will include various measurements of weather such as temperature, pressure, humidity, wind and physiological measurements such as sleep duration and quality and activity level measured through a wearable Fitbit device.

    Time frame: 10 weeks

  2. AUC of individual prediction models using post prediction data on environmental and physiological variables.

    The metric and the type of the data is the same as in Outcome 1. The only difference is that the data is obtained from the user after the model is trained. The user is not shown the prediction to avoid expectancy bias.

    Time frame: 10 weeks

07

Study locations

2 sites
  • Mayo Clinic Arizona
    Scottsdale, Arizona 852589, United States
  • University of Southern California
    Los Angeles, California 90033, United States
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2016 to primary completion in Jul 2018, 20 months.

Of 160 observational studies under Migraine Disorders, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 63. This study's 20 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 13, 2016
First posted
Sep 22, 2016
StartActual
Nov 2016
Primary completionActual
Jul 2018
CompletionActual
Jul 31, 2018
Last update
Aug 6, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02910921
Lead sponsor
Second Opinion Health
Responsible party
Sponsor
First posted
Sep 22, 2016
Start date
Nov 2016
Primary completion
Jul 2018
Completion
Jul 31, 2018
Last update
Aug 6, 2018

Study contacts

Rashmi Halker Singh, MD
principal investigator · Mayo Clinic
Soma Sahai-Srivastava, MD
principal investigator · University of Southern California

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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