Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315673
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-03-12
Brief Title:
Digital Assessment of Speech and Fine Motor Control in ALS
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Digital Assessment of Speech and Fine Motor Control in ALS
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-session case-control study that incorporates digital tools for assessing speech and motor function in motor neuron disease Patients with motor neuron disease including amyotrophic lateral sclerosis ALS primary lateral sclerosis PLS and progressive muscular atrophy PMA and age-matched healthy controls will be enrolled Subjects will complete a speech and handwriting assessment during the study visit on a tablet computer BioSensics LLC Newton MA We will explore whether these digital biomarkers are sensitive to functional disease severity as reported by the ALS Functional Rating Scale - Revised ALFRS-R 1 We will also compare assessment data between the patient and control groups
Detailed Description:
ALS is a progressive neuromuscular disease that causes weakness and inevitably affecting multiple motor processes within the body To assess changes in functional mobility clinicians and clinical investigators often rely on the ALS Functional Rating Scale - Revised ALSFRS-R a standardized 12-item questionnaire that has been in use for decades Although thoroughly validated this scale has received criticism for providing a coarse reflection of a patients disease scaling non-linearly within and across functional domains and without the sensitivity to reflect day-to-day variability or small but meaningful changes
This study includes collection of digital speech and fine motor control assessment data at a single study visit Features extracted from this data will be compared with standard clinical disease outcome measures and also the features derived from control participant data We will use these comparisons to explore the use of these digital assessments in capturing the range of functional changes that occur in ALS and the related motor neuron diseases of PLS and PMA that are regularly treated in the ALS clinic
This study includes collection of digital speech and fine motor control assessment data at a single study visit Features extracted from this data will be compared with standard clinical disease outcome measures and also the features derived from control participant data We will use these comparisons to explore the use of these digital assessments in capturing the range of functional changes that occur in ALS and the related motor neuron diseases of PLS and PMA that are regularly treated in the ALS clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None