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

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:

1. 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? 2. Which clinical outcome measures collected through DHT are sensitive indicators of ALS progression? 3. 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

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Key information

Conditions

ALS (Amyotrophic Lateral Sclerosis) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Barrow Neurological Institute, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Other

Collaborators

Emory University
Tanabe Pharma America, Inc.

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Mar 11, 2022
Registry last updated: Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed