RecruitingNCT06315673

Digital Assessment of Speech and Fine Motor Control in ALS

Sponsor

Milton S. Hershey Medical Center

Enrollment

50 participants

Start Date

Jul 1, 2024

Study Type

OBSERVATIONAL

Conditions

Amyotrophic Lateral Sclerosis Primary Lateral Sclerosis Progressive Muscular Atrophy

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

\[Patient Group Only\] 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.

Exclusion Criteria5

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).

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Interventions

BEHAVIORALDigital Speech and Handwriting Assessment

Subjects may complete all or some of these tests, depending on functional ability. * Handwriting battery * Pattern tracing battery * Speech Assessment Battery