Digital assessment of speech and motor control in ALS
Digital Assessment of Speech and Fine Motor Control in ALS
This study is testing how well digital tools can measure speech and movement in people with ALS and other motor neuron diseases to see if they provide better information than standard tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT06315673 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates speech and fine motor control in patients with motor neuron diseases, including ALS, PLS, and PMA, using digital tools. Participants will undergo a single-session assessment where they will complete speech and handwriting tasks on a tablet. The study aims to compare the digital assessment results with traditional clinical measures, specifically the ALS Functional Rating Scale - Revised, to determine the sensitivity of these digital biomarkers to disease severity. The findings may enhance understanding of functional changes in these conditions.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with ALS, PLS, or PMA who have at least minimal speech or handwriting ability.
Not a fit: Patients with significant neurological or orthopedic issues affecting speech or handwriting may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more sensitive and accurate method for monitoring disease progression in ALS and related conditions.
How similar studies have performed: While the use of digital assessments in neuromuscular diseases is emerging, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Hershey, Pennsylvania
- Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Andrew Geronimo, PhD
- Email: ageronimo@pennstatehealth.psu.edu
- Phone: 7175310003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.