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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
Sponsor:
Collaborators:
Emory University
Mitsubishi Tanabe Pharma America Inc.
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix

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 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


Condition or disease
ALS (Amyotrophic Lateral Sclerosis)

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
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





Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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.


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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
Study Population
Patients will be recruited from the ALS patient populations cared for at the BNI and Emory University ALS Clinics. For the virtual recruitment of ALS patients outside of those clinics, the study details with contact information will be posted on IRB-approved websites, social media, and patient advocacy groups, including the Northeast ALS Consortium (NEALS), ALS Association (ALSA) websites and other ALS forums. The National ALS Registry will also be used to promote recruitment.
Criteria

Inclusion Criteria:

  1. Male or female, age 18 to 90.
  2. Diagnosed with definite, probable, or possible ALS according to the modified El Escorial Criteria (EEC) or diagnosed with ALS using the Gold Coast Criteria.
  3. Must be able to ambulate independently at the time of enrollment, with or without the use of foot braces or cane.
  4. A vital capacity score of ≥40% of the predicted value (at last known in-person visit and if available).
  5. Intelligible speech with occasional repetition.
  6. Willingness and medical ability to comply with scheduled visits and study procedures.
  7. 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).
  8. Possession of a smartphone, and willingness to install study apps on it.
  9. Continuous internet access at home, with stable broadband internet access.
  10. Sufficiently proficient in English to understand and complete questionnaires and follow instructions using smartphone apps.

Exclusion Criteria:

  1. Diagnosed with a superimposed medical condition that could confound study procedures in the opinion of the investigator.
  2. 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.
  3. Any other reasons that, in the opinion of the PI, the candidate is determined to be unsuitable for entry into the study.

Information from the National Library of Medicine

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


Contacts
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Contact: Praveena Mohan, PhD 602-406-3032 praveena.mohan@dignityhealth.org
Contact: Katherine Cummings 602-406-6262 katherine.cummings@emory.edu

Locations
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United States, Arizona
Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact: Praveena Mohan, PhD    602-406-3032    praveena.mohan@dignityhealth.org   
Principal Investigator: Jeremy Shefner, MD, PhD         
Sub-Investigator: Bill Jacobsen, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Katherine Cummings    602-406-6262    Katherine.Cummings@emory.edu   
Principal Investigator: Jonathan D. Glass, MD         
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Emory University
Mitsubishi Tanabe Pharma America Inc.
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Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT05276349    
Other Study ID Numbers: DHI-10012021-ALS
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases