Remote Speech and Swallowing Assessment in ALS

NCT04889898 | Active Not Recruiting DMC

• 1 other identifier: STUDY00016872
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose a longitudinal home study of ALS patients to measure the severity of speech and swallowing (bulbar) impairment via a smartphone-based, remote speech and swallow assessment (rSSA). The study is designed to assess the feasibility and validity of such a monitoring intervention. Furthermore, it is proposed that regular monitoring of these two bulbar processes may shed light on their co-evolution over the course of ALS.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

telemonitoring; digital health; mobile health; dysphagia; dysarthria

Outcome Measures

Primary Outcomes (1)

• Digital recording of speech and swallow

  Audio recordings of speech tasks and spontaneous swallowing task

  weekly for 24 weeks

Secondary Outcomes (8)

• MBS Impairment Profile (MBSImp)

  Weeks 0 and 24

• Speech Intelligibility Task (SIT) Intelligibility listener scoring

  Weeks 0, 12, and 24

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

  Weeks 0, 12, and 24

• Center for Neurological Study - Bulbar Function Scale (CNS-BFS)

  Weeks 0, 4, 8, 12, 16, 20, and 24

• Mann Assessment of Swallowing Ability (MASA)

  Weeks 0, 12, and 24

Study Arms (2)

ALS Patients

All ALS patients will be enrolled in this arm, which involves a combination of clinical and home-based assessments of speech and swallowing.

Device: Digital recording of speech and swallow sounds using the Beiwe Digital Health App on a personal smartphone; Radiation: Modified Barium Swallow Study (MBSS); Behavioral: Speech Intelligibility Test (SIT)

Listeners

Healthy listeners will be recruited to listen to the audio recordings of patients in the study in order to judge the intelligibility of their speech.

Behavioral: SIT Scoring

Interventions

Digital recording of speech and swallow sounds using the Beiwe Digital Health App on a personal smartphone DEVICE

\[Patients only\] Weekly completion of audio recordings of speech and swallowing performed at home by the subject using the study smartphone application on their personal device.

ALS Patients

Modified Barium Swallow Study (MBSS) RADIATION

\[Patients only\] MBSS is an instrumented evaluation of oropharyngeal swallowing function that is performed using videofluoroscopy.

Also known as: Videofluoroscopic Swallowing Study (VFSS)

ALS Patients

Speech Intelligibility Test (SIT) BEHAVIORAL

\[Patients only\] The SIT is a standardized test for measuring speech intelligibility.

ALS Patients

SIT Scoring BEHAVIORAL

\[Listeners only\] Listeners will judge the intelligibility of speech recordings made by patients in the study.

Listeners

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

Population 1: Patients with ALS Population 2: Healthy Listeners

You may qualify if:

• Patients
• At least 18 years of age
• Possess a diagnosis of ALS (definite, probable, probable laboratory-supported, or possible by El Escorial criteria \[35\])
• Have symptom onset within the last 3 years
• Demonstrate a score of 2 or 3 in either the speech (item #1) or swallowing (item #3) components of the ALSFRS-R at time of enrollment
• Demonstrate decline in bulbar function prior to enrollment, measured by a reduction of at least 1 point on either the speech or swallowing components of the ALSFRS-R in the 6 months prior to enrollment. If 6 months of data is not available, an estimate of the change in ALSFRS-R will be calculated from the time of symptom onset.
• Have a life expectancy ≥ 6 months as determined by the attending neurologist
• Be fluent in written and spoken English
• Possess a smartphone capable of running the study application
• Follow up in the Penn State Hershey multidisciplinary ALS clinic over next 6 months
• Be able to visit the study site for in-person procedures at weeks 0 and 24
• Listeners
• Between 18 and 40 years of age
• Native speakers of American English 2.3. Currently residing within the United States. 3.4. Hearing within normal limits, as defined by self report.

You may not qualify if:

• Patients
• Possess a co-existing neurological or psychiatric illness that, in the opinion of the study team, exclude the subject from participation
• Demonstrate clinically significant dementia, as determined by the ALS study neurologist
• Possess abnormal speech or swallowing processes due to a condition independent of their ALS diagnosis
• Listeners
• Have an identified speech, language, learning, or neurological disorders per self-report
• Experience communicating with people with motor speech disorders

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Penn State University: collaborator
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Hershey Medical Center ALS Clinic

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Deglutition Disorders; Dysarthria

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Geronimo, PhD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Neurosurgery

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 17, 2021
• Study Start: January 1, 2022
• Primary Completion: August 31, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)