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

NCT02910921 | Completed

• 1 other identifier: 16-005803
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  10 weeks

• 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.

  10 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with episodic migraines

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

Sponsors & Collaborators

• Second Opinion Health: lead
• Mayo Clinic: collaborator
• University of Southern California: collaborator
• Allergan: collaborator

Study Sites (2)

Mayo Clinic Arizona

Scottsdale, Arizona, 852589, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Related Links

• Migraine
• Migraine Headaches

MeSH Terms

Conditions

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Rashmi Halker Singh, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Soma Sahai-Srivastava, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 22, 2016
• Study Start: November 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 31, 2018
• Last Updated: August 6, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)