Actively Recruiting
Digital Assessment of Speech and Fine Motor Control in ALS
Led by Milton S. Hershey Medical Center · Updated on 2025-07-08
50
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
M
Milton S. Hershey Medical Center
Lead Sponsor
B
BioSensics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Digital Assessment of Speech and Fine Motor Control in ALS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient group: Diagnosed with definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial criteria, primary lateral sclerosis, or progressive muscular atrophy.
- Patient group: At least minimal speech or handwriting ability (ALSFRS-R speech score of 2 or greater, or handwriting score of 2 or greater).
- Control group: No neurological or orthopedic problems affecting speech or handwriting and age-matched to patient group.
- Age 18 years or older.
- Fluent in written and spoken English.
You will not qualify if you...
- Current or previous enrollment in STUDY00013892 (NCT05271435).
- Neurological or orthopedic problems affecting speech or handwriting, other than the included diagnoses.
- Pregnant or nursing women.
- Prisoners or institutionalized individuals.
- Any other clinically relevant medical history or disease that excludes participation, including severe cognitive dysfunction.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
Research Team
A
Andrew Geronimo, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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