Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06315673

Digital Assessment of Speech and Fine Motor Control in ALS

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

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.

CONDITIONS

Official Title

Digital Assessment of Speech and Fine Motor Control in ALS

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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.
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

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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Digital Assessment of Speech and Fine Motor Control in ALS | DecenTrialz