Clinical trial NCT04889898: Remote Speech and Swallowing Assessment in ALS
Official title: Home Telemonitoring of Bulbar Function by Acoustic Measurement of Swallowing and Speech Sounds in ALS
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Keywords: telemonitoring
digital health
mobile health
dysphagia
dysarthria
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Penn State University
name: Congressionally Directed Medical Research Programs
First posted: 2021-05-17
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population 1: Patients with ALS Population 2: Healthy Listeners

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.

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

Primary outcomes:
measure: Digital recording of speech and swallow
timeFrame: weekly for 24 weeks
Secondary outcomes:
measure: MBS Impairment Profile (MBSImp)
timeFrame: Weeks 0 and 24
measure: Speech Intelligibility Task (SIT) Intelligibility listener scoring
timeFrame: Weeks 0, 12, and 24
measure: ALS Functional Rating Scale - Revised (ALSFRS-R)
timeFrame: Weeks 0, 12, and 24
measure: Center for Neurological Study - Bulbar Function Scale (CNS-BFS)
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Mann Assessment of Swallowing Ability (MASA)
timeFrame: Weeks 0, 12, and 24
measure: EAT-10 Questionnaire
timeFrame: Weeks 0, 12, and 24
measure: Forced Vital Capacity (FVC)
timeFrame: Weeks 0, 12, and 24
measure: Maximal Inspiratory Pressure (MIP)
timeFrame: Weeks 0, 12, and 24
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Hershey Medical Center ALS Clinic
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Andrew Geronimo, PhD
role: PRINCIPAL_INVESTIGATOR
References: