RECRUITING

Digital Assessment of Speech and Fine Motor Control in ALS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Digital Assessment of Speech and Fine Motor Control in ALS

Quick Facts

Study Start:2024-07-01
Study Completion:2027-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06315673

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. \[Patient Group Only\] at least minimal speech or handwriting ability
  3. 1. ALSFRS-R speech score of 2 ("intelligible speech with repeating") or greater, OR
  4. 2. ALSFRS-R handwriting score of 2 ("not all words are legible") or greater.
  5. 3. \[Control Group Only\] Possess no neurological or orthopedic problems that affects their speech or handwriting AND age-matched to the existing patient cohort.
  6. 4. 18 years of age or older;
  7. 5. Fluent in written and spoken English.
  1. 1. Currently or previously enrolled in STUDY00013892 (NCT05271435)
  2. 2. Neurological or orthopedic problems (independent of their inclusionary diagnosis for the patient group) that affects their speech or handwriting
  3. 3. Pregnant or nursing woman
  4. 4. Prisoner or institutionalized individuals
  5. 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).

Contacts and Locations

Study Contact

Andrew Geronimo, PhD
CONTACT
7175310003
ageronimo@pennstatehealth.psu.edu

Study Locations (Sites)

Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2027-03-30

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2027-03-30

Terms related to this study

Additional Relevant MeSH Terms

  • Amyotrophic Lateral Sclerosis
  • Primary Lateral Sclerosis
  • Progressive Muscular Atrophy