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Home-based Remote Digital Monitoring to Assess ALS Progression (Track-ALS)

What is the purpose of the study?

The purpose of this study is to see whether at-home measurements are dependable and can help with tracking disease progression. 

What procedures will I participate in if I choose to enroll in the study?

You will be required to do various testing at your home using applications installed in your smartphone at different time points. The equipment needed to complete these assessments will be provided to you. The assessments required will include:

  • Breathing test
  • Speech recordings
  • Activity Tracking
  • Health questionnaires
als clinical trial participant using a Bluetooth spirometer

What are some of the things necessary for me to be eligible to participate in the study?

  • You must be between the ages of 18 and 90 years old
  • You must be diagnosed with ALS, with the symptom onset of weakness appearing in the last 5 years
  • You must own a Smart Device with Bluetooth capabilities
  • You must have continuous internet access at home

The full list of eligibility requirements will be provided during the screening process.

Will I need to come to the study site for study visits?

All assessments will be completed in your home. Some of the assessments will be done through virtual visits (phone or video calls).

track als clinical trial participant using a smartphone app

How long will I be in the study?

Your total participation would be for 12 months.  

What are the risks of the study?

The risks and discomfort associated with testing of breathing function may include feeling tired, light-headed, or short of breath. These symptoms will disappear with rest.

The risks and discomforts associated with speech tracking may include fatigue from the effort of speaking. This symptom will disappear with rest.

The questionnaires may cause you to feel sad or upset about how ALS has changed how well you can perform daily activities, and how it has affected your quality of life.

What are the benefits of the study?

Although, you will not benefit directly by taking part in this research study, knowledge gained from the study may benefit others in the future. Your participation may contribute valuable data to ALS research.

Study Contact Information

If you appear to meet the criteria for the Track-ALS study and you wish for a member of study to contact you, please complete the pre-screening survey at this time. Jeremy Shefner, MD, PhD, and Jonathan D. Glass, MD, are conducting the Track-ALS research study at Barrow Neurological Institute and Emory University.  

If you have questions about the pre-screening survey or the Track-ALS research study, please feel free to ask. You may contact the study team at (602) 406-6262 or TrackALSstudy@DignityHealth.org.   

Status
Open and enrolling subjects.
Location
Phoenix, Arizona
Primary Sponsor
Mitsubishi Tanabe Pharma Holdings America, Inc
Additional Sponsor(s)
Barrow Neurological Institute
Emory University