Home-based Remote Digital Monitoring to Assess ALS Progression (Track ALS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05276349|
Recruitment Status : Recruiting
First Posted : March 11, 2022
Last Update Posted : November 17, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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.
- 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.
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, PhDemail@example.com|
|Contact: Katherine Cummingsfirstname.lastname@example.org|
|United States, Arizona|
|Barrow Neurological Institute||Recruiting|
|Phoenix, Arizona, United States, 85013|
|Contact: Praveena Mohan, PhD 602-406-3032 email@example.com|
|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|
|Responsible Party:||St. Joseph's Hospital and Medical Center, Phoenix|
|Other Study ID Numbers:||
|First Posted:||March 11, 2022 Key Record Dates|
|Last Update Posted:||November 17, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases