NCT06266403

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 age-matched speakers. The question is, What are the effects of communicative interaction on verbal communication in people with ALS? Participants will read words and sentences while they are in a solo setting and interactive setting.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started Nov 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Nov 2024Feb 2029

First Submitted

Initial submission to the registry

January 29, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

November 5, 2024

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

4.3 years

First QC Date

January 29, 2024

Last Update Submit

January 9, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Formant frequencies of speech sounds

    Formant frequencies that characterize speech sounds will be made on speech recorded in the intervention task.

    two 60 minute sessions

  • Intelligibility of recorded speech

    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.

    two 60 minute sessions

  • Syntactic properties

    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.

    One 60 minute session

  • Pragmatic Properties

    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.

    One 60 minute session

  • Duration of speech sounds

    Durations that characterize speech sounds will be made on speech recorded in the intervention task.

    two 60 minute sessions

Study Arms (1)

People with amyotrophic lateral sclerosis, age-matched speakers

EXPERIMENTAL

People with ALS and age-matched speakers will participate in structured communicative interaction.

Behavioral: Structured Communicative InteractionBehavioral: Clear SpeechBehavioral: Unstructured communicative interactionBehavioral: Clear Speech Structured Communicative Interaction

Interventions

Two interlocutors, one with ALS and a typical, unfamiliar interlocutor or an age-matched speaker and a typical interlocutor, will work together. On each trial, one of the interlocutors will be randomly chosen to be the "speaker" and the other will be the "listener". 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.

People with amyotrophic lateral sclerosis, age-matched speakers
Clear SpeechBEHAVIORAL

PALS and age-matched speakers will read critical words consisting of target segments (e.g., "hid", "ship", "net") in random order four times. These words will be embedded in the carrier phrase "Click on the \_\_\_ this time." Participations will be instructed to overenunciate the critical words.

People with amyotrophic lateral sclerosis, age-matched speakers

Two interlocutors, one with ALS and a typical, unfamiliar interlocutor or an age-matched speaker and a typical interlocutor, 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.

People with amyotrophic lateral sclerosis, age-matched speakers

Two interlocutors, one with ALS and a typical, unfamiliar interlocutor or an age-matched speaker and a typical interlocutor, will work together. On each trial, one of the interlocutors will be randomly chosen to be the "speaker" and the other will be the "listener". 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. The speaker will be instructed to overenunciate the critical words. After the listener has made their selection, both participants will receive feedback on trial success.

People with amyotrophic lateral sclerosis, age-matched speakers

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • Age-matched Speakers
  • passing the remote hearing screening
  • having no known speech, language, or neurological disorders per self-report
  • no cognitive impairment assessed by Telephone Montreal Cognitive Assessment (mini MoCA)
  • being a functionally native monolingual speaker of American English.
  • Unfamiliar Interlocutors
  • passing the remote hearing screening
  • having no known speech, language or neurological disorders per self-report
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Speech Core, Pennsylvania State University

University Park, Pennsylvania, 16802, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32302251BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jimin Lee, PhD

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR
  • Navin Viswanathan, PhD

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR
  • Anne Olmstead, PhD

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Olmstead, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: PALS and age-matched adults will participate in one solo speech production task (clear speech) and three interactive tasks (structured communicative interaction, unstructured communicative interaction, and clear speech structured communicative interaction) in which they work with an unfamiliar, naive interlocutor. This study is designed to examine the differences in speech produced in the four tasks. Comparisons of speech produced by PALS and age-matched adults will clarify whether differences in speech observed across the four tasks are a function of the speech difficulties experiences by PALS. Plans for Assignment - This is a single group study in which all participants will engage in the same tasks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 20, 2024

Study Start

November 5, 2024

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2029

Last Updated

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

The project will involve the collection of audio samples, perceptual judgments, and questionnaire data. All deidentified data will be shared through the Open Science Framework (osf.io). All scripts, protocols, procedures, and analyses will be shared along with the deidentified data to ensure that other researchers can verify and build on the presented results. All shared data will be made available in a format that is accessible by open-access software (e.g., R, Open Office, pdf reader). In addition, platform-specific scripts (e.g., experimental software LabVanced) will be shared with explanations so that they may be implemented across different software environments.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be shared after publication of the study.
Access Criteria
All deidentified data, metadata, and related tools will be freely available via Open Science Framework (OSF). The original audio files will be made available (for participants who consent) by request from researchers in the field to ensure responsible use.

Locations