Remote Speech and Swallowing Assessment in ALS

NCT ID: NCT04889898

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 170 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2026-09-30

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.

Detailed Description

Most individuals with ALS experience bulbar function deterioration over the course of the disease which impacts their quality of life significantly. Furthermore, in some patients, bulbar symptoms are an initial presenting symptom of ALS. Identifying these changes, which may be rapid in some individuals, is complicated by the recent acceleration of virtual care delivery.

The investigators propose a longitudinal home study of ALS patients to assess bulbar progression via a smartphone-based, self-administered remote speech and swallow assessment (rSSA). The overall hypothesis is that this monitoring protocol can be used in a way that, 1) is satisfactory to the patient, 2) performs at least as well as standard clinical measures of dysarthria and dysphagia, and 3) resolves the development of emergence of speech and swallowing pathologies in ALS.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

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

Intervention Type: 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.

Modified Barium Swallow Study (MBSS)

Intervention Type: RADIATION

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

Speech Intelligibility Test (SIT)

Intervention Type: BEHAVIORAL

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

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.

SIT Scoring

Intervention Type: BEHAVIORAL

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

Interventions

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

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

Intervention Type: DEVICE

Modified Barium Swallow Study (MBSS)

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

Intervention Type: RADIATION

Speech Intelligibility Test (SIT)

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

Intervention Type: BEHAVIORAL

SIT Scoring

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Videofluoroscopic Swallowing Study (VFSS)

Eligibility Criteria

Inclusion Criteria

Patients

1. At least 18 years of age

2. Possess a diagnosis of ALS (definite, probable, probable laboratory-supported, or possible by El Escorial criteria [35])

3. Have symptom onset within the last 3 years

4. 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

5. 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.

6. Have a life expectancy ≥ 6 months as determined by the attending neurologist

7. Be fluent in written and spoken English

8. Possess a smartphone capable of running the study application

9. Follow up in the Penn State Hershey multidisciplinary ALS clinic over next 6 months

10. Be able to visit the study site for in-person procedures at weeks 0 and 24

Listeners

1. Between 18 and 40 years of age

2. Native speakers of American English 2.3. Currently residing within the United States. 3.4. Hearing within normal limits, as defined by self report.

Exclusion Criteria

Patients

1. Possess a co-existing neurological or psychiatric illness that, in the opinion of the study team, exclude the subject from participation

2. Demonstrate clinically significant dementia, as determined by the ALS study neurologist

3. Possess abnormal speech or swallowing processes due to a condition independent of their ALS diagnosis

Listeners

1. Have an identified speech, language, learning, or neurological disorders per self-report

2. Experience communicating with people with motor speech disorders

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Penn State University

OTHER

Sponsor Role: collaborator

Congressionally Directed Medical Research Programs

FED

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Andrew Geronimo

Assistant Professor, Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Geronimo, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

Hershey Medical Center ALS Clinic

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY00016872

Identifier Type: -

Identifier Source: org_study_id