Research studies for migraine are conducted for many reasons and employ different methods of collecting data. Amgen, a biotech company that's developing one of the CGRP migraine medications that we've discussed, is launching an innovative virtual study for people with migraine disease.
The study is designed to better understand how migraine symptoms relate to physical activity levels. The purpose of the study is to test the hypothesis that changes in activity as tracked by number of steps per unit time will correlate with migraine occurrence. This is a virtual study. Participants will not be required to make site visits or meet with site investigators and staff in-person during the 90-day study period. Data about activity levels will be measured using an Apple watch, which will be supplied to accepted study participants by Amgen. Participating in the study takes about 10 to 20 minutes each day for 90 days, and participants need to wear the Apple watch during their waking hours for those 90 days.
Study participation requirements:
Study participants must:
- be between 18 and 65 years old.
- have experienced migraines for at least one year.
- have had six or more migraine attacks in the last six months.
- be under the care of a neurologist or migraine specialist.
- have an iPhone.
- be capable of wearing an Apple watch during the day.
To determine if you're eligible, you will need to complete:
- pre-screening questions,
- a migraine eligibility questionnaire to assess the nature of your "headaches," and
- other eligibility questions.
Prospective participants need to download the free Amgen Migraine Tracker App to their iPhone from the Apple App Store, set up an account in the app, and answer questions to determine their eligibility for the study. If selected for the study, participants will be given instructions on documenting migraine episodes during the 90-day study period.
Accepted study participants:
If accepted into the study:
- Study participants will be mailed an Apple Watch which will be used to track their activity level (number of steps).
- Participants who complete the study as directed may keep the Apple watch at the end of the study.
- The Amgen service desk personnel will contact subjects via phone to help with the installation and pairing of the Migraine Tracker App with their Apple watch.
- Study participants will be asked to answer questions on a daily and monthly basis
- Study participants will be asked to record the start and stop time of their migraine episodes throughout the 90-day period.
- The questionnaires will take approximately 10-20 minutes a day to complete.
Summary and comments:
This is quite an innovate study. It's good to see technology being used in this fashion. Given current technology and the interest in wearable technology including trackers such as the Fitbit, I'm sure we'll see more studies utilizing wearable technology.
If you want to see if you're eligible for this virtual study, please open iTunes and search for "Amgen Migraine Tracker" in the app store. If you're eligible and participate in this study, please come back and post a comment at the end of this post. We'll all be interested in your experience
Interesting articles about wearable technology:
Fitbit lends wearable tech to Dana-Farber for breast cancer study
Digital Technology: Enhancing the doctor/patient relationship in new ways in radiation oncology