Digital Assessment of Speech and Fine Motor Control in ALS

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• \[Patient Group Only\] 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.

Locations
United States
Pennsylvania
Milton S. Hershey Medical Center
RECRUITING
Hershey
Contact Information
Primary
Andrew Geronimo, PhD
ageronimo@pennstatehealth.psu.edu
7175310003
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2027-03-30
Participants
Target number of participants: 50
Treatments
Patient
Individuals with diagnosis of definite, probable, probable laboratory-supported, or possible ALS by revised El Escorial research criteria \[2\], primary lateral sclerosis (PLS), or progressive muscular atrophy (PMA).
Control
Individuals with no neurological or orthopedic problems that affects their speech or handwriting AND age-matched to the existing patient cohort.
Sponsors
Collaborators: BioSensics
Leads: Milton S. Hershey Medical Center

This content was sourced from clinicaltrials.gov