Digital Assessment of Speech and Fine Motor Control in ALS

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT06315673
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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 Dates

Start date
Jul 1, 2024
Status verified
Jul 2025
Primary completion
Mar 30, 2026
Completion
Mar 30, 2027

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: 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).
  • Arm: Control
    Individuals with no neurological or orthopedic problems that affects their speech or handwriting AND age-matched to the existing patient cohort.

Primary Outcome Measure

Speaking rate during a standardized passage [ Time Frame: baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Milton S. Hershey Medical CenterHersheyPennsylvania17033
Andrew Geronimo, PhD
[email protected]
717-531-0003

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By research site
Milton S. Hershey Medical Center· Hershey, PA

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