Home-based Remote Digital Monitoring to Assess ALS Progression (Track ALS)
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|ClinicalTrials.gov Identifier: NCT05276349|
Recruitment Status : Recruiting
First Posted : March 11, 2022
Last Update Posted : November 17, 2022
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 of 80 ALS patients will be recruited across US, and will involve two sites - St. Joseph Hospital and Medical Center in Phoenix, AZ, and Emory University ALS Clinic in Atlanta. This will be a fully remote observational study and will employ remote data collection platforms such as (a) A digital spirometry device powered by a mobile app will be used to measure vital capacity; (b) A clinical-grade voice recording app will be used to evaluate speech function; (c) A medical-grade wearable sensor will be used to monitor activity levels and sleep patterns; and (d) Standardized Electronic Clinical Outcome Assessments (eCOA) and Patient Reported Outcomes (ePRO) will be used to evaluate quality of life and cognitive abilities.
The main goals of this study is to answer some of these questions:
- Can ALS patients measure important aspects of disease progression at home, either by themselves with appropriate training or with assistance of a coordinators via virtual visit?
- Which clinical outcome measures collected through DHT are sensitive indicators of ALS progression?
- Are the measures reproducible and whether they can correlate with gold standard assessments?
The results of this study have the potential to provide valuable information for designing future ALS trials that are more decentralized, more patient-centric, and require less visits to the clinic which typically become a major burden with disease progression
|Condition or disease|
|ALS (Amyotrophic Lateral Sclerosis)|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Home-based Remote Digital Monitoring to Assess ALS Progression (Track ALS)|
|Actual Study Start Date :||February 21, 2022|
|Estimated Primary Completion Date :||March 1, 2024|
|Estimated Study Completion Date :||March 1, 2024|
- Feasibility of at-home assessments [ Time Frame: 12 months ]The average number of at-home assessments completed by each subject will be calculated each quarter using Wald method
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05276349
|Contact: Praveena Mohan, PhDfirstname.lastname@example.org|
|Contact: Katherine Cummingsemail@example.com|
|United States, Arizona|
|Barrow Neurological Institute||Recruiting|
|Phoenix, Arizona, United States, 85013|
|Contact: Praveena Mohan, PhD 602-406-3032 firstname.lastname@example.org|
|Principal Investigator: Jeremy Shefner, MD, PhD|
|Sub-Investigator: Bill Jacobsen, MD|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Contact: Katherine Cummings 602-406-6262 Katherine.Cummings@emory.edu|
|Principal Investigator: Jonathan D. Glass, MD|