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

ALS (Amyotrophic Lateral Sclerosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05276349
• Other study ID #: DHI-10012021-ALS
• Status: Active, not recruiting
• Start date: February 21, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: July 2023
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: August 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• ALS (Amyotrophic Lateral Sclerosis)
• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Barrow Neurological Institute	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
St. Joseph's Hospital and Medical Center, Phoenix	Emory University, Mitsubishi Tanabe Pharma America Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of at-home assessments	The average number of at-home assessments completed by each subject will be calculated each quarter using Wald method	12 months