The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III).
J M Cedarbaum, N Stambler, E Malta...
https://pubmed.ncbi.nlm.nih.gov/10540002Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID06315673
Digital Assessment of Speech and Fine Motor Control in Amyotrophic Lateral Sclerosis and Related Motor Neuron Diseases
Led by Milton S. Hershey Medical Center · Updated on 2025-07-08
50
Participants Needed
1
Research Sites
52 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
Researchers are evaluating digital tools to measure speech and fine motor control in people with motor neuron diseases such as amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and progressive muscular atrophy (PMA). This study compares these digital assessments with the traditional ALS Functional Rating Scale - Revised (ALSFRS-R) to see if they better capture disease severity and daily functional changes. Age-matched healthy individuals will also be included for comparison. During a single study visit, participants will complete speech and handwriting tests on a tablet computer. These tests include a handwriting battery, pattern tracing battery, and speech assessment battery. The study collects data from both patients and healthy controls to explore how well these digital measures reflect the range of functional changes in these motor neuron diseases. Participants will undergo assessments including speaking rate during a standardized passage and a spiral tracing task. Additional evaluations include ALSFRS-R scores, lung function tests (forced vital capacity), upper motor neuron function, and strength testing. The study aims to understand how digital tools compare to standard clinical measures, with all data collected during one visit. The total time commitment is limited to this single session.
CONDITIONS
Brief Title
Digital Assessment of Speech and Fine Motor Control in ALS
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Diagnosis of definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial criteria, primary lateral sclerosis (PLS), or progressive muscular atrophy (PMA) for patient group
- At least minimal speech or handwriting ability with ALSFRS-R speech score of 2 or greater, or ALSFRS-R handwriting score of 2 or greater for patient group
- No neurological or orthopedic problems affecting speech or handwriting for control group
- Age 18 years or older
- Fluent in written and spoken English
You will not qualify if you...
- Currently or previously enrolled in study NCT05271435
- Neurological or orthopedic problems affecting speech or handwriting unrelated to patient group diagnosis
- Pregnant or nursing women
- Prisoners or institutionalized individuals
- Any other clinically relevant medical history or disease excluding participation, including severe cognitive dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Digital Speech and Handwriting Assessment
Duration - 1 day
Participants complete digital assessments including handwriting, pattern tracing, and speech batteries to evaluate speech and fine motor control.
1 study visit (in-person)
Trial Site Locations
Total: 1 location
1
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
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Research Team
A
Andrew Geronimo, PhD
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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Published Research Related To This Trial
El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis.
B R Brooks, R G Miller, M Swash...
https://pubmed.ncbi.nlm.nih.gov/11464847