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NCT Number: NCT06819124

Examining Interactions Between PALS and Caregivers

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Speech Core, Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location status: Recruiting

Location contact

Jimin Lee, Ph.D.

CONTACT

[email protected]

814-867-3373

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured Communicative Interaction

Behavioral

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.

Unstructured communicative interaction

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Olmstead, Ph.D.

CONTACT

[email protected]

814-867-3373

Navin Viswanathan, Ph.D

CONTACT

[email protected]

814-867-2340

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Examining Interactions Between Persons With ALS and Caregivers

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Feb 11, 2025
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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