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 ALS and Related Motor Neuron Diseases
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
Researchers are evaluating digital tools to assess 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). The study compares patients with these conditions to age-matched healthy individuals. The goal is to determine if these digital assessments can better capture disease severity and functional changes compared to traditional methods like the ALS Functional Rating Scale - Revised (ALSFRS-R).
CONDITIONS
Official 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...
- 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
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1
2
3
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