Amyotrophic Lateral Sclerosis (ALS)NCT06819124
Examining Interactions Between PALS and Caregivers
A study testing Structured Communicative Interaction and Unstructured communicative interaction in people with Amyotrophic Lateral Sclerosis (ALS), 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 their caregivers. 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 (ALS)
- What is being tested?
- Structured Communicative Interaction 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
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2025to 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 10Show fewer
- 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).
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, Ph.D., 814-867-3373, jxl91@psu.edu
About this study
Official title: Examining Interactions Between Persons With ALS 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.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- Structured Communicative Interaction, Unstructured 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 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 interactionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| People with ALS and their caregivers | Experimental | People with ALS and their caregivers will participate in structured communicative interaction. Receives: Behavioral: Structured Communicative Interaction; Behavioral: Unstructured 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: Two 60 minute sessions
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: Two 60 minute sessions
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 posted11 Feb 2025
- Study start22 Jan 2025
- 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 Sclerosis (ALS)Studies 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 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.
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Ji Min Lee, Ph.D., Penn State University
- Investigators
- Jimin Lee, Ph.D., Principal investigator, Penn State UniversityAnne Olmstead, Ph.D., Principal investigator, Penn State UniversityNavin Viswanathan, Ph.D., Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819124
- Sponsor's protocol ID
- STUDY00024154-1
- Other IDs
- R01DC021714
- Status last verified
- Apr 2026
- First submitted
- 4 Feb 2025
- Last updated
- 6 Apr 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, 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.
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 32302251
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Interactions Between Persons With ALS and Caregivers
- ClinicalTrials.gov ID
- NCT06819124
- Acronym / sponsor ID
- STUDY00024154-1
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 11 Feb 2025 (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 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.
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 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.
| Arm | Type | Receives |
|---|---|---|
| People with ALS and their caregivers | Experimental | Behavioral: Structured Communicative Interaction, Behavioral: Unstructured communicative interactionPeople with ALS and their caregivers 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 (10 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 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. | Behavioural | People with ALS and their caregivers |
| Unstructured communicative interactionTwo 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. | Behavioural | People with ALS and their caregivers |
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: 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.
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 6 Apr 2026.
- 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.
- 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.
- 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, Ph.D. principal investigator
Penn State University
Anne Olmstead, Ph.D. principal investigator
Penn State University
Navin Viswanathan, Ph.D. principal investigator
Penn 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 and Unstructured communicative interaction in people with Amyotrophic Lateral Sclerosis (ALS), 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 10 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 6 Apr 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 NCT06819124, 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 6 Apr 2026.