Status:
COMPLETED
Home-based Remote Digital Monitoring to Assess ALS Progression (Track ALS)
Lead Sponsor:
St. Joseph's Hospital and Medical Center, Phoenix
Collaborating Sponsors:
Emory University
Tanabe Pharma America, Inc.
Conditions:
ALS (Amyotrophic Lateral Sclerosis)
Eligibility:
All Genders
18-90 years
Brief Summary
The purpose of this study is to study use of advance Digital Health Technologies (DHT) and its validity as measures for assessing progression in Amyotrophic Lateral Sclerosis (ALS) patients. A total o...
Eligibility Criteria
Inclusion
- Male or female, age 18 to 90.
- Diagnosed with definite, probable, or possible ALS according to the modified El Escorial Criteria (EEC) or diagnosed with ALS using the Gold Coast Criteria.
- Must be able to ambulate independently at the time of enrollment, with or without the use of foot braces or cane.
- A vital capacity score of ≥40% of the predicted value (at last known in-person visit and if available).
- Intelligible speech with occasional repetition.
- Willingness and medical ability to comply with scheduled visits and study procedures.
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI).
- Possession of a smartphone, and willingness to install study apps on it.
- Continuous internet access at home, with stable broadband internet access.
- Sufficiently proficient in English to understand and complete questionnaires and follow instructions using smartphone apps.
Exclusion
- Diagnosed with a superimposed medical condition that could confound study procedures in the opinion of the investigator.
- Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the participant's ability to comply with the protocol.
- Any other reasons that, in the opinion of the PI, the candidate is determined to be unsuitable for entry into the study.
Key Trial Info
Start Date :
February 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 28 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05276349
Start Date
February 21 2022
End Date
August 28 2024
Last Update
November 12 2024
Active Locations (2)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
Emory University
Atlanta, Georgia, United States, 30322