Amyotrophic Lateral Sclerosis (ALS)
Conditions
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.
Interventions
BEHAVIORALUnstructured communicative interaction
Two interlocutors, one with ALS and their caregiver will work together. The pairs will be presented with two different versions of the same picture with eight differences chosen to elicit the same target segments (e.g., "hid", "ship", "net"). These pictures will be modified from the LUCID corpus. In total, pairs will complete four picture sets per session. Pairs will be given 5 minutes for each picture set.
BEHAVIORALStructured Communicative Interaction
Two interlocutors, one with ALS and their caregiver will work together. Each participant in the pair will view the same set of words on their screens. After one second, one of the words will be highlighted on the speaker's screen, they will say the word in the phrase "Click on the \_\_\_\_ this time", and the listener will click on it. After the listener has made their selection, both participants will receive feedback on trial success.
Sponsors
Penn State University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Formant frequencies of speech sounds | two 60 minute sessions | Formant frequencies that characterize speech sounds will be made on speech recorded in the intervention task. |
| Intelligibility of recorded speech | two 60 minute sessions | Perceptual judgments will be provided by solo, naïve listeners who did not participate in the interactions. Listeners will hear recorded speech of PALS and age-matched speakers recorded across the different tasks and indicate what they heard. The score will be expressed in percent. The possible range is between 0-100%. The higher scores mean a better outcome. |
| Syntactic properties | Two 60 minute sessions | Syntactic complexity in the unstructured communication task will be measured through mean length of grammatical units, clausal density, and clause type. Each variable will be assessed at both the dyadic level (e.g., clausal density for both interlocutors together) and at the level of the individual speaker (e.g., clausal density of each speaker). A composite of these measures will provide an index of the syntactic complexity of the conversation. |
| Pragmatic Properties | Two 60 minute sessions | The investigators will count the number and duration of silent portions of speech, filled pauses, linguistic mazes, speaking turns, and interruptions in the unstructured communication task. A composite measure of the individual measures will provide an index of an individual's contribution to the conversation. |
| Duration of speech sounds | two 60 minute sessions | Durations that characterize speech sounds will be made on speech recorded in the intervention task. |
Countries
United States
Contacts
CONTACTAnne Olmstead, Ph.D.
CONTACTNavin Viswanathan, Ph.D
PRINCIPAL_INVESTIGATORJimin Lee, Ph.D.
Penn State University
PRINCIPAL_INVESTIGATORAnne Olmstead, Ph.D.
Penn State University
PRINCIPAL_INVESTIGATORNavin Viswanathan, Ph.D.
Penn State University
Outcome results
None listed