Digital Assessment of Speech and Fine Motor Control in ALS

Completed

Conditions studied: Amyotrophic Lateral Sclerosis, Primary Lateral Sclerosis, Progressive Muscular Atrophy

In brief

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.

Key facts

Study ID

NCT06315673

Run by

Milton S. Hershey Medical Center

People needed

42

Starts

2024-07-01

Expected to finish

2026-06-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• [Patient Group Only] Diagnosis of definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial research criteria [Brooks2000], primary lateral sclerosis (PLS), or progressive muscular atrophy (PMA).
• [Patient Group Only] at least minimal speech or handwriting ability
• ALSFRS-R speech score of 2 ("intelligible speech with repeating") or greater, OR
• ALSFRS-R handwriting score of 2 ("not all words are legible") or greater.
• [Control Group Only] Possess no neurological or orthopedic problems that affects their speech or handwriting AND age-matched to the existing patient cohort.
• 18 years of age or older;
• Fluent in written and spoken English.

You may not qualify if…

• Currently or previously enrolled in STUDY00013892 (NCT05271435)
• Neurological or orthopedic problems (independent of their inclusionary diagnosis for the patient group) that affects their speech or handwriting
• Pregnant or nursing woman
• Prisoner or institutionalized individuals
• Have any clinically relevant medical history of other disease or diseases that, in the opinion of the research team, exclude the subject from participation (including severe cognitive dysfunction).

Where it is running

• Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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