Digital Assessment of Speech and Fine Motor Control in ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Digital Assessment of Speech and Fine Motor Control in ALS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06315673
• Other study ID #: STUDY00024562
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: March 30, 2027

Study information

• Verified date: May 2024
• Source: Milton S. Hershey Medical Center
• Contact: Andrew Geronimo, PhD
• Phone: 7175310003
• Email: ageronimo[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

ALS is a progressive neuromuscular disease that causes weakness and inevitably affecting multiple motor processes within the body. To assess changes in functional mobility, clinicians and clinical investigators often rely on the ALS Functional Rating Scale - Revised (ALSFRS-R), a standardized 12-item questionnaire that has been in use for decades. Although thoroughly validated, this scale has received criticism for providing a coarse reflection of a patient's disease, scaling non-linearly within and across functional domains, and without the sensitivity to reflect day-to-day variability or small but meaningful changes.

This study includes collection of digital speech and fine motor control assessment data at a single study visit. Features extracted from this data will be compared with standard clinical disease outcome measures and also the features derived from control participant data. We will use these comparisons to explore the use of these digital assessments in capturing the range of functional changes that occur in ALS and the related motor neuron diseases of PLS and PMA that are regularly treated in the ALS clinic.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 30, 2027
• Est. primary completion date: March 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Primary Lateral Sclerosis
• Progressive Muscular Atrophy
• Sclerosis

Intervention

Behavioral:
• Digital Speech and Handwriting Assessment
Subjects may complete all or some of these tests, depending on functional ability. Handwriting battery Pattern tracing battery Speech Assessment Battery

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	BioSensics

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	ALS Functional Rating Scale- Revised (ALSFRS-R)	The ALSFRS-R measures 12 aspects of physical function, ranging from one's ability to swallow and use utensils to climbing stairs and breathing. Each function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0.	baseline
Secondary	Forced vital capacity (FVC)	FVC is collected at clinical appointments by a respiratory therapist. FVC is the volume of air that is forcefully expelled into a spirometer. FVC is expressed as a percentage (%) of predicted volume against an age, height, and ethnicity matched standard. The best result of three trials is used.	baseline
Secondary	Upper motor neuron function	Reflex testing is performed by the attending neurologist at clinical appointments. Bilateral biceps, triceps, and brachioradialis reflexes will be documented according to Modified Ashworth Scale grade 0 (no tone increase) to 4 (limb rigid). Total score for bilateral muscle groups ranges from 0 to 24.	baseline
Secondary	Strength testing	Strength testing is performed by the attending neurologist at clinical appointments. Bilateral deltoids, biceps, triceps, wrist extension, and interossei strength will be documented according to Medical Research Council (MRC) grade 0 (no power) to 5 (normal power). Total score for bilateral muscle groups ranges from 0 to 50.	baseline