Remote Speech and Swallowing Assessment in ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Home Telemonitoring of Bulbar Function by Acoustic Measurement of Swallowing and Speech Sounds in ALS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04889898
• Other study ID #: STUDY00016872
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Milton S. Hershey Medical Center
• Contact: Andrew Geronimo, PhD
• Phone: 717-531-0003
• Email: ageronimo[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

Device:
• 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.

Radiation:
• Modified Barium Swallow Study (MBSS)
[Patients only] MBSS is an instrumented evaluation of oropharyngeal swallowing function that is performed using videofluoroscopy.

Behavioral:
• Speech Intelligibility Test (SIT)
[Patients only] The SIT is a standardized test for measuring speech intelligibility.
• SIT Scoring
[Listeners only] Listeners will judge the intelligibility of speech recordings made by patients in the study.

Locations

Country	Name	City	State
United States	Hershey Medical Center ALS Clinic	Hershey	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Congressionally Directed Medical Research Programs, Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Digital recording of speech and swallow	Audio recordings of speech tasks and spontaneous swallowing task	weekly for 24 weeks
Secondary	MBS Impairment Profile (MBSImp)	Standardized scoring for the MBSS in 17 domains. Domains are aggregated in to scores for Oral Impairment (0-22), Pharyngeal Impairment (0-29), and Esophageal Impairment (0-4), with higher scores indicating impaired function.	Weeks 0 and 24
Secondary	Speech Intelligibility Task (SIT) Intelligibility listener scoring	Listeners will score the intelligibility of patient SIT recordings	Weeks 0, 12, and 24
Secondary	ALS Functional Rating Scale - Revised (ALSFRS-R)	ALS Specific Assessment of physical function ranging from 0-48, with 48 being normal function.	Weeks 0, 12, and 24
Secondary	Center for Neurological Study - Bulbar Function Scale (CNS-BFS)	Self-administered rating scale for speech (7-49) and salivation (7-35) functions, with high scores indicating impaired function.	Weeks 0, 4, 8, 12, 16, 20, and 24
Secondary	Mann Assessment of Swallowing Ability (MASA)	A standard clinical swallowing assessment performed by the speech-language pathologist. Scores range from 38-200, with lower scores indicating higher impairment.	Weeks 0, 12, and 24
Secondary	EAT-10 Questionnaire	A self-reported assessment of eating and swallowing function. Scores range from 0-40, with higher scores indicating higher impairment.	Weeks 0, 12, and 24
Secondary	Forced Vital Capacity (FVC)	A standard clinical respiratory assessment of vital capacity	Weeks 0, 12, and 24
Secondary	Maximal Inspiratory Pressure (MIP)	A standard clinical respiratory assessment of inspiratory strength	Weeks 0, 12, and 24