NCT06315673Completed
Digital Assessment of Speech and Fine Motor Control in ALS
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 42 (actual)
- First submitted
- 12 Mar 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Milton S. Hershey Medical Center
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06315673
What you commit to
- Study type: Observational
- Participants enrolled: 42
- From 1 Jul 2024 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently or previously enrolled in STUDY00013892 (NCT05271435)
Other illness
- 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).
Other
- 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
Who the study is looking for
- \[Patient Group Only\] 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Milton S. Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.