Recruiting

Observational Study

Sponsor:

Penn State University

Code:

NCT06819124

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Structured Communicative Interaction

Unstructured communicative interaction

Study Details

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 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.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Study ID

NCT06819124

Start date

Jan 22, 2025

Status verified date

Apr, 2026

Completion date

Feb 28, 2029

Anticipated

Primary completion date

Feb 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

152 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: People with ALS and their caregivers

People with ALS and their caregivers will participate in structured communicative interaction.

Interventions

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.

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 measure

  • Formant frequencies of speech sounds [ Time Frame: two 60 minute sessions ]
  • Intelligibility of recorded speech [ Time Frame: two 60 minute sessions ]
  • Syntactic properties [ Time Frame: Two 60 minute sessions ]
  • Pragmatic Properties [ Time Frame: Two 60 minute sessions ]
  • Duration of speech sounds [ Time Frame: two 60 minute sessions ]

Central Contacts and Locations

Central contacts

Anne Olmstead, Ph.D.

814-867-3373ajo150@psu.edu

Navin Viswanathan, Ph.D

814-867-2340nxv175@psu.edu

Locations

Speech Core, Pennsylvania State University

Recruiting

University Park, Pennsylvania, United States, 16802

Contacts

Jimin Lee, Ph.D.

814-867-3373jxl91@psu.edu

More Information

Sponsor

Penn State University

Last update posted

Apr 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Penn State University on 2026-04-06.