Amyotrophic Lateral SclerosisNCT06266403
Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications
A study testing Structured Communicative Interaction, Clear Speech and Unstructured communicative interaction in people with Amyotrophic Lateral Sclerosis, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Structured Communicative Interaction, Clear Speech and Unstructured communicative interaction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2024to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
- being a native monolingual speaker of American English
- having no experience communicating with people with dysarthria
- being between the ages of 18 and 40.
Who cannot join
- None - if volunteer meets the inclusion criteria, then they will be enrolled
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Speech Core, Pennsylvania State University
University Park, Pennsylvania, 16802
Jimin Lee, PhD, 814-867-3373, jxl91@psu.edu
About this study
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.
Read the detailed description
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.
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 = 100 PALS in order to account for speech variability that is common for PALS. The investigators plan to recruit 50 age-matched speakers. The investigators anticipate that this sample size will be sufficient to make appropriate comparison to the PALS group because there will be considerably less variability in these speakers.
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Structured Communicative Interaction, Clear Speech, Unstructured communicative interaction, Clear Speech Structured Communicative Interaction
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Communicative InteractionBehavioural
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.
Clear SpeechBehavioural
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.
Unstructured communicative interactionBehavioural
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.
Clear Speech Structured Communicative InteractionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| People with amyotrophic lateral sclerosis, age-matched speakers | Experimental | People with ALS and age-matched speakers will participate in structured communicative interaction. Receives: Behavioral: Structured Communicative Interaction; Behavioral: Clear Speech; Behavioral: Unstructured communicative interaction; Behavioral: Clear Speech Structured Communicative Interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Formant frequencies of speech sounds
Formant frequencies that characterize speech sounds will be made on speech recorded in the intervention task.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One 60 minute session
Duration of speech sounds
Durations that characterize speech sounds will be made on speech recorded in the intervention task.
Measured: two 60 minute sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start5 Nov 2024
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Min Lee, Ph.D., Penn State University
- Investigators
- Jimin Lee, PhD, Principal investigator, The Pennsylvania State UniversityNavin Viswanathan, PhD, Principal investigator, The Pennsylvania State UniversityAnne Olmstead, PhD, Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266403
- Sponsor's protocol ID
- STUDY00024154
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 32302251Olmstead, 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications
- ClinicalTrials.gov ID
- NCT06266403
- Acronym / sponsor ID
- STUDY00024154
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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 = 100 PALS in order to account for speech variability that is common for PALS. The investigators plan to recruit 50 age-matched speakers. The investigators anticipate that this sample size will be sufficient to make appropriate comparison to the PALS group because there will be considerably less variability in these speakers.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| People with amyotrophic lateral sclerosis, age-matched speakers | Experimental | Behavioral: Structured Communicative Interaction, Behavioral: Clear Speech, Behavioral: Unstructured communicative interaction, Behavioral: Clear Speech Structured Communicative InteractionPeople with ALS and age-matched speakers will participate in structured communicative interaction. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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)
Key exclusion criteria (1 listed)
- None - if volunteer meets the inclusion criteria, then they will be enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Communicative InteractionTwo 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. | Behavioural | People with amyotrophic lateral sclerosis, age-matched speakers |
| Clear SpeechPALS 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. | Behavioural | People with amyotrophic lateral sclerosis, age-matched speakers |
| Unstructured communicative interactionTwo 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. | Behavioural | People with amyotrophic lateral sclerosis, age-matched speakers |
| Clear Speech Structured Communicative InteractionTwo 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. | Behavioural | People with amyotrophic lateral sclerosis, age-matched speakers |
Primary outcome
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: One 60 minute session
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: One 60 minute session
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 32302251Olmstead 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.
- BackgroundOlmstead, 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jimin Lee, PhD principal investigator
The Pennsylvania State University
Navin Viswanathan, PhD principal investigator
The Pennsylvania State University
Anne Olmstead, PhD principal investigator
The Pennsylvania State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Communicative Interaction, Clear Speech and Unstructured communicative interaction in people with Amyotrophic Lateral Sclerosis, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Olmstead, Ph.D. (814-867-3373, ajo150@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Formant frequencies of speech sounds (time frame: two 60 minute sessions). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06266403, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.