Digital Assessment of Speech and Fine Motor Control in ALS

NCT06315673 | Recruiting

• 1 other identifier: STUDY00024562
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Amyotrophic Lateral Sclerosis; Primary Lateral Sclerosis; Progressive Muscular Atrophy

Outcome Measures

Primary Outcomes (2)

• Speaking rate during a standardized passage

  Speaking rate, in words per minute, will be determined from an audio recording of a standardized reading passage.

  baseline

• Residual on spiral tracing task

  Handwriting tasks include tracing of a spiral. The average residual, or deviation from the target spiral (in pixels), will be determined from the handwriting file associated with the tracing task.

  baseline

Secondary Outcomes (4)

• ALS Functional Rating Scale- Revised (ALSFRS-R)

  baseline

• Forced vital capacity (FVC)

  baseline

• Upper motor neuron function

  baseline

• Strength testing

  baseline

Study Arms (2)

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).

Behavioral: Digital Speech and Handwriting Assessment

Control

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

Behavioral: Digital Speech and Handwriting Assessment

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

Control; Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with motor neuron disease and age- and sex-matched, neurologically-healthy controls.

You may qualify if:

• \[Patient Group Only\] 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.
• years of age or older;
• Fluent in written and spoken English.

You may not qualify if:

• Currently or previously enrolled in STUDY00013892 (NCT05271435)
• Pregnant or nursing woman
• Prisoner or institutionalized individuals
• 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).

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• BioSensics: collaborator

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Related Publications (2)

• Cedarbaum JM, Stambler N, Malta E, Fuller C, Hilt D, Thurmond B, Nakanishi A. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). J Neurol Sci. 1999 Oct 31;169(1-2):13-21. doi: 10.1016/s0022-510x(99)00210-5.

  PMID: 10540002 BACKGROUND

• Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec;1(5):293-9. doi: 10.1080/146608200300079536. No abstract available.

  PMID: 11464847 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Andrew Geronimo, PhD

CONTACT

7175310003; ageronimo@pennstatehealth.psu.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Neurosurgery

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 18, 2024
• Study Start: July 1, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: Data will become available upon publication

Locations

US (1)