ALS (Amyotrophic Lateral Sclerosis) Clinical Trial
Official title:
Home-based Remote Digital Monitoring to Assess ALS Progression (Track ALS)
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
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02528071 -
Prognostic Value of a Diaphragmatic Endurance Test in Patients With Amyotrophic Lateral Sclerosis
|
||
| Active, not recruiting |
NCT03604822 -
Music Therapy Protocol to Support Bulbar and Respiratory Functions in ALS
|
N/A | |
| Completed |
NCT02891629 -
Safety and Feasibility of the EyeControl Device
|
N/A | |
| Completed |
NCT02164253 -
Focal Accumulation of Iron in Cerebral Regions in Early ALS (Amyotrophic Lateral Sclerosis) Patients
|
Phase 2 | |
| Completed |
NCT00786032 -
A Clinical Demonstration of EEG Brain-computer Interface for ALS Patients
|
N/A | |
| Recruiting |
NCT03787420 -
Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS.
|
N/A | |
| Recruiting |
NCT05663008 -
Impairments of Neuro-muscular Communication in Motor-Neuron Disease: A Bio-Marker for Early and Personalised Diagnosis
|
||
| Active, not recruiting |
NCT02286011 -
Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients With Amyotrophic Lateral Sclerosis
|
Phase 1 | |
| Recruiting |
NCT03330353 -
Chromatic Pupillometry to Assess the Melanopsin-Light Pathway in Progressive Supranuclear Palsy
|
N/A | |
| Active, not recruiting |
NCT03081338 -
A Programme for Amyotrophic Lateral Sclerosis Care in Europe
|
N/A | |
| Active, not recruiting |
NCT03241784 -
T-Regulatory Cells in Amyotrophic Lateral Sclerosis
|
Phase 1 | |
| Not yet recruiting |
NCT04849065 -
Clinical Trial on the Use of Cell Therapy in the Treatment of Patients With Amyotrophic Lateral Sclerosis
|
Phase 2 | |
| Completed |
NCT04090684 -
Ciprofloxacin/Celecoxib Combination in Patients With ALS
|
Phase 1 | |
| Active, not recruiting |
NCT04055623 -
T-regulatory Cells in ALS
|
Phase 2 | |
| Completed |
NCT02709330 -
ALS Reversals - Lunasin Regimen
|
Phase 2 | |
| Completed |
NCT03482050 -
A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS)
|
Phase 1/Phase 2 |