NCT06819124 · Penn State University
Examining Interactions Between PALS and Caregivers
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Structured 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.
BEHAVIORAL
Unstructured 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.
Primary outcome measures
Formant frequencies of speech sounds
Time frame: two 60 minute sessions
Formant frequencies that characterize speech sounds will be made on speech recorded in the intervention task.
Intelligibility of recorded speech
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: two 60 minute sessions
Durations that characterize speech sounds will be made on speech recorded in the intervention task.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- University Park, Pennsylvania
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 6, 2026 · Source of record for eligibility and locations