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Search / Trial NCT06315673

Digital Assessment of Speech and Fine Motor Control in ALS

Launched by MILTON S. HERSHEY MEDICAL CENTER · Mar 12, 2024

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how well digital tools can assess speech and fine motor skills in people with motor neuron diseases, such as amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and progressive muscular atrophy (PMA). The study will involve patients who have been diagnosed with these conditions and healthy individuals of the same age for comparison. During the trial, participants will use a tablet to complete tasks that measure their speech and handwriting abilities. Researchers want to see if the results from these digital assessments can accurately reflect the severity of their condition, as evaluated by a specific rating scale.

To be eligible for this study, patients must have a confirmed diagnosis of ALS, PLS, or PMA, and should be able to speak or write at least a little. Healthy participants must not have any neurological or orthopedic issues that could affect their speech or handwriting and should be matched in age with those in the patient group. All participants should be at least 18 years old and fluent in English. If you decide to take part, you can expect a single visit where you'll complete these assessments using a tablet. This trial is currently recruiting participants, and your involvement could help improve understanding and treatment for these conditions.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. \[Patient Group Only\] 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).
  • 2. \[Patient Group Only\] at least minimal speech or handwriting ability
  • 1. ALSFRS-R speech score of 2 ("intelligible speech with repeating") or greater, OR
  • 2. ALSFRS-R handwriting score of 2 ("not all words are legible") or greater.
  • 3. \[Control Group Only\] Possess no neurological or orthopedic problems that affects their speech or handwriting AND age-matched to the existing patient cohort.
  • 4. 18 years of age or older;
  • 5. Fluent in written and spoken English.
  • Exclusion Criteria:
  • 1. Currently or previously enrolled in STUDY00013892 (NCT05271435)
  • 2. Neurological or orthopedic problems (independent of their inclusionary diagnosis for the patient group) that affects their speech or handwriting
  • 3. Pregnant or nursing woman
  • 4. Prisoner or institutionalized individuals
  • 5. 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).

About Milton S. Hershey Medical Center

Milton S. Hershey Medical Center, a leading academic medical institution affiliated with Penn State University, is dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, the center leverages its expertise in various medical fields to conduct rigorous clinical studies aimed at improving treatment outcomes and enhancing the understanding of complex health conditions. The facility is committed to ethical research practices and fostering collaboration among multidisciplinary teams, ensuring that participants receive the highest standard of care while contributing to the advancement of medical knowledge.

Locations

Hershey, Pennsylvania, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported