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

Study Purpose:

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Observational Study

Study Category:

home-based digital assessments

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Jeremy Shefner, MD, PhD   (Barrow Neurological Institute)
Jonathan D. Glass, MD   (Emory University)

Clinicaltrials.gov ID (11 digit #):

Neals Affiliated?

Yes

Coordinating Center Contact Information

Barrow Neurological Institute
Praveena Mohan / .(JavaScript must be enabled to view this email address) / 602-406-3032
Katie Terrebonne / .(JavaScript must be enabled to view this email address) / 404-727-5193
240 W Thomas Road, Suite #400
Phoenix , Arizona 85013 United States

Full Study 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

Study Sponsor:

Mitsubishi Tanabe Pharma Holdings America

Participant Duration:

12 months

Estimated Enrollment:

80

Estimated Study Start Date:

02/26/2022

Estimated Study Completion Date:

03/01/2024

Posting Last Modified Date:

03/10/2022

Date Study Added to alsconsortium.org:

03/09/2022
  • More Information

    Anyone interested in the study can complete an online pre-screening survey at - https://redcap.dignityhealth.org/surveys/?s=3AXDLA9CM7CEKNH8

  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    90

    Min Vital Capacity (% predicted normal):

    50

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    Participant must own a smart device with Bluetooth capabilities and have continuous internet access at home

  • Site Contact Information

    Barrow Neurological Institute
    Praveena Mohan / .(JavaScript must be enabled to view this email address) / 602-406-6262
    240 W Thomas Road
    Phoenix, Arizona 85013
    United States

    Emory University
    Katherine Cummings / .(JavaScript must be enabled to view this email address) / 404-727-5193
    101 Woodruff Cir., Suite 6000
    Atlanta, Georgia 30322
    United States