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.
Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis (ALS) , Familial ALS , Sporadic ALS
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Jeremy Shefner, MD, PhD (Barrow Neurological Institute) Jonathan D. Glass, MD (Emory University)
Clinicaltrials.gov ID:
Neals Affiliated?
Yes
Coordinating Center Contact Information
Barrow Neurological Institute
Praveena Mohan / email hidden; JavaScript is required / 602-406-3032
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:
- 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
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 neals.org:
03 / 09 / 2022
Anyone interested in the study can complete an online pre-screening survey at - https://redcap.dignityhealth.org/surveys/?s=3AXDLA9CM7CEKNH8
Minimum Age:
18
Maximum Age:
90
Can participants use Riluzole?
Yes
Participant must own a smart device with Bluetooth capabilities and have continuous internet access at home
Barrow Neurological Institute
Praveena Mohan / 602-406-6262 / email hidden; JavaScript is required
Phoenix, Arizona
85013
United States
Emory University
Katherine Cummings / 404-727-5193 / email hidden; JavaScript is required
Atlanta, Georgia
30322
United States