Clinical trial NCT06819124: Examining Interactions Between PALS and Caregivers
Official title: Examining Interactions Between Persons with ALS and Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2025-02-11
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: PALS and Caregivers will participate in two sets (pre-test and post-test) of interactive tasks two weeks apart. Over two weeks, they will complete the collaborative word-matching task ten times (once every weekday for an average of 10 mins/day) on their own.

The study is designed to examine two things. First, to examine the speech produced by PALS with familiar interlocutors. Second, to examine the changes in speech production as a function of collaborative practice.

Plans for Assignment - This is a single group study in which all participants will engage in the same tasks.
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to learn about the effect of communicative interaction on verbal communication in people with amyotrophic lateral sclerosis (ALS) and their caregivers.

The question is, What are the effects of communicative interaction on verbal communication in people with ALS when they interact with their caregivers and does this change over time?

Participants will read words and sentences while they are interacting with their caregivers.

Detailed description: PALS and Caregivers will participate in two sets (pre-test and post-test) of interactive tasks two weeks apart. Over two weeks, they will complete the collaborative word-matching task ten times (once every weekday for an average of 10 mins/day) on their own.

The study is designed to examine two things. First, to examine the speech produced by PALS with familiar interlocutors. Second, to examine the changes in speech production as a function of collaborative practice.

Plans for Assignment - This is a single group study in which all participants will engage in the same tasks.

Delivery of Intervention: Using tablets and audio recording devices provided to them, participants will complete this task in the comfort of their home. Study protocols will be explained via videoconferencing by experimenters. Produced speech will be recorded using solid-state audio recorders as well as remotely through the video conferencing software.

Adequacy of Sample size. Assuming medium effect sizes (Cohen's f = 0.3) based on our pilot data, for 80% power at an alpha of .05, the investigators will require 76 speakers. The investigators propose n =76 PALS and their caregivers (total 152) in order to account for speech variability that is common for PALS.

Adequacy of Analyses. The proposed statistical analyses (Generalized mixed effects regressions) are standard and will be used to analyze the effect of the intervention on the outcome measures described below. Severity of condition (for PALS) will be included in the analyses and by-subject slopes and intercepts will be used to account for variability across participants.

Eligibility criteria: Inclusion Criteria:

Speakers with amyotrophic lateral sclerosis (ALS) (PALS-people with ALS)

* diagnosis of ALS following the revised EL Escorial criteria
* no history of other neurological conditions (e.g., stroke)
* no cognitive impairment assessed by Telephone Montreal Cognitive Assessment (mini MoCA)
* detectable speech disturbance according to the ALS Functional Rating Scale-Revised (ALSFRS-R)
* the ability to produce single words
* being a native speaker of American English (AE).

Caregivers

* being a caregiver of a participant with ALS
* being a native speaker of American English (AE).

Exclusion Criteria:

- None - if volunteer meets the inclusion criteria, then they will be enrolled

Primary outcomes:
measure: Formant frequencies of speech sounds
timeFrame: two 60 minute sessions
measure: Intelligibility of recorded speech
timeFrame: two 60 minute sessions
measure: Syntactic properties
timeFrame: Two 60 minute sessions
measure: Pragmatic Properties
timeFrame: Two 60 minute sessions
measure: Duration of speech sounds
timeFrame: two 60 minute sessions
Secondary outcomes:
Other outcomes:
Locations:
city: University Park
country: United States
facility: Speech Core, Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Jimin Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Anne Olmstead, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Navin Viswanathan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olmstead, A. J., Viswanathan, N., Cowan, T., & Yang, K. (2021). Phonetic adaptation in interlocutors with mismatched language backgrounds: A case for a phonetic synergy account. Journal of Phonetics, 87, 101054.
citation: Olmstead AJ, Lee J, Viswanathan N. The Role of the Speaker, the Listener, and Their Joint Contributions During Communicative Interactions: A Tripartite View of Intelligibility in Individuals With Dysarthria. J Speech Lang Hear Res. 2020 Apr 27;63(4):1106-1114. doi: 10.1044/2020_JSLHR-19-00233. Epub 2020 Apr 17.