Communicative Interaction for ALS

Overseen By Anne Olmstead, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Disqualifiers: Stroke, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

152 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different communication methods might assist people with amyotrophic lateral sclerosis (ALS) and their caregivers. Specifically, it examines how structured and unstructured interactions impact verbal communication and whether these effects change over time. Participants will read words and sentences while interacting with their caregivers. Individuals with ALS who have noticeable speech difficulties and can speak single words may be suitable candidates. Their caregivers must also speak American English. As an unphased trial, this study provides participants the chance to contribute to significant research that could enhance communication strategies for ALS patients and their caregivers.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that communicative interaction is safe for people with ALS and their caregivers?

Research has shown that communication methods like Clear Speech and Communicative Interaction are safe for people with ALS. These methods help improve communication skills, and past studies have found no harmful effects. Participants have generally handled these techniques well, with no major negative effects reported. This suggests that talking with caregivers, whether in a structured or casual way, is safe for individuals with ALS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on enhancing communication for people with ALS, a condition where communication can become challenging due to muscle weakness. Unlike traditional treatments that often aim to slow disease progression or manage symptoms with medication, this trial explores "Structured Communicative Interaction" as a way to improve the quality of life by fostering better communication between patients and their caregivers. This approach is unique because it emphasizes behavioral and social interaction techniques rather than relying solely on medical or technological interventions. By focusing on structured communication, the trial may pave the way for more effective support systems that significantly enhance daily interactions for those affected by ALS.

What evidence suggests that structured communicative interaction is effective for improving verbal communication in people with ALS?

Studies have shown that most people with ALS struggle to communicate, and up to 95% may eventually lose their ability to speak. Caregivers can assist by adjusting how they listen and respond, which can improve communication for ALS patients. Research indicates that these methods help caregivers understand the unique ways ALS patients speak. This can enhance verbal communication between patients and caregivers, helping them maintain meaningful interactions. Participants in this trial will engage in structured communicative interaction to explore these benefits further. ^{1 3 6 7 8}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

This trial is for individuals with ALS (Lou Gehrig's disease) and their caregivers. It aims to understand how structured and unstructured communication affects verbal interaction over time. Participants will engage in reading tasks with their caregivers.

Inclusion Criteria

Caregivers must be a caregiver of a participant with ALS

Speakers with ALS must have no cognitive impairment assessed by Telephone Montreal Cognitive Assessment (mini MoCA)

I can speak single words despite having ALS.

Exclusion Criteria

None - if volunteer meets the inclusion criteria, then they will be enrolled

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-test

Participants engage in initial interactive tasks to assess baseline speech characteristics

1 week

1 session (virtual)

Intervention

Participants complete collaborative word-matching tasks with caregivers using tablets and audio recording devices

2 weeks

10 sessions (home-based)

Post-test

Participants engage in follow-up interactive tasks to assess changes in speech characteristics

1 week

1 session (virtual)

Follow-up

Participants are monitored for any long-term changes in speech and communication effectiveness

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Structured Communicative Interaction
• Unstructured Communicative Interaction

Trial Overview The study examines two types of communicative interactions: structured, where specific guidelines are followed, and unstructured, which is more free-form. The impact on verbal communication between people with ALS and their caregivers is being measured.

How Is the Trial Designed?

Group I: People with ALS and their caregivers Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

A new classification system for advanced ALS patients identifies five stages of communication disturbance, which helps in understanding the severity of communication issues as the disease progresses.

Patients who reach stage V, where they cannot communicate at all, tend to start using a ventilator earlier and often have a family history of ALS, indicating that rapid disease progression may predict a poor long-term prognosis for communication abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Communication disorder in amyotrophic lateral sclerosis after ventilation--a proposal of staging and a study of predictive factor]. Hayashi, K., Mochizuki, Y., Nakayama, Y., et al.[2019]

Handwriting can serve as an effective communication tool for individuals with ALS/MND, especially when they have intact upper limb control, allowing them to engage in conversations with their spouses.

The study highlights the importance of how recipients respond to handwritten messages, as their reactions can significantly influence the interaction and communication dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Handwriting-in-interaction between people with ALS/MND and their conversation partners. Bloch, S., Clarke, M.[2022]

In a study involving ALS patients, it was found that less than 40% of recommendations made by multidisciplinary clinics were recalled, with the highest recall and compliance related to physical function recommendations.

The study suggests that enhancing patient understanding, providing problem-solving skills, and increasing follow-up between visits could improve recall and compliance with recommendations, ultimately leading to better patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with recommendations made in a multidisciplinary ALS clinic. Fullam, T., Stephens, HE., Felgoise, SH., et al.[2016]

The ALS Functional Rating Scale-Revised (ALSFRS-R) can effectively track changes in function over time, regardless of whether the evaluation is performed by patients, caregivers, or healthcare providers.

Even if evaluators change during a clinical trial, such as when assessments are done by patients instead of providers, the impact on the overall score is minimal (less than one point), suggesting the scale's robustness in various evaluation scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inter-evaluator reliability of the ALS functional rating scale. Miano, B., Stoddard, GJ., Davis, S., et al.[2019]

Individuals with amyotrophic lateral sclerosis (ALS) experience significant challenges in social communication, particularly in areas like starting conversations and being sensitive to conversation partners, as reported by informants.

Interestingly, ALS participants did not recognize their own social communication difficulties, highlighting a lack of self-awareness that suggests the need for comprehensive assessments that include both self-reports and informant feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing social communication changes in amyotrophic lateral sclerosis. Fisher, F., Philpott, A., Andrews, SC., et al.[2018]

A significant majority (80-95%) of individuals with amyotrophic lateral sclerosis (ALS) will eventually struggle to communicate effectively using natural speech due to motor speech disorders like dysarthria.

Timely referral for augmentative and alternative communication (AAC) assessment is crucial, as many patients can benefit from AAC interventions even close to the end of life, highlighting the importance of early intervention in maintaining communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication Support for People with ALS. Beukelman, D., Fager, S., Nordness, A.[2021]

A study involving 21 individuals with amyotrophic lateral sclerosis (pALS) highlighted the importance of three key principles in augmentative and alternative communication (AAC): timely assessment and intervention, inclusion of communication partners, and the use of various communication strategies.

Most participants felt that their AAC assessment and intervention experiences incorporated these best practices, suggesting that personalized approaches are essential for effectively supporting pALS with complex communication needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Augmentative and Alternative Communication (AAC) Will Give You a Voice": Key Practices in AAC Assessment and Intervention as Described by Persons with Amyotrophic Lateral Sclerosis. McNaughton, D., Giambalvo, F., Kohler, K., et al.[2019]

Caregivers of individuals with ALS reported that AAC technology is most frequently used for basic communication needs, such as getting needs met and giving instructions, highlighting its importance in daily interactions.

Despite challenges like slow message production, face-to-face communication remains the preferred mode, indicating that AAC technology plays a crucial role in maintaining social connections and relationships for ALS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Purposes of AAC device use for persons with ALS as reported by caregivers. Fried-Oken, M., Fox, L., Rau, MT., et al.[2018]

A 3-year study on communication among people with ALS and their partners revealed that communication challenges extend beyond physical speech difficulties, highlighting the importance of interaction strategies used by both parties.

Despite speech deterioration, many individuals with ALS can still engage in meaningful communication by focusing on topics that matter to them, suggesting that effective communication can be maintained through adaptive strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication strategies of people with ALS and their partners. Murphy, J.[2022]

In a study of 30 ALS patients over six months, the ALS Functional Rating Scale (ALSFRS-R) was found to provide the most complete data and best predict survival outcomes, making it a reliable measure for early phase clinical trials.

Patients perceived a significant change in their clinical function only when there was a 9-point decrease in the ALSFRS-R, indicating that larger changes may be necessary for patients to notice treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome measures for early phase clinical trials. Gordon, PH., Cheng, B., Montes, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12138489/

Implications for Novel Speech Interventions Researchers have suggested interventions that help PALS's communication partners tune their speech perception systems to PALS's production.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7949226/

Communicative Participation in People with Amyotrophic ... Communication is affected in most people with amyotrophic lateral sclerosis (ALS); up to 80–95% will reach a point where they are no longer able ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022510X24004647

Improving care for amyotrophic lateral sclerosis with ... This study introduces a novel approach to linking pulse and speech analysis to evaluate emotional responses in ALS patients.

4. digitalcommons.murraystate.edu digitalcommons.murraystate.edu/cgi/viewcontent.cgi?article=1244&context=honorstheses

Efficacy of Communication Interventions for Amyotrophic ... The purpose of this literature review is to analyze the efficacy of various communication interventions for amyotrophic lateral sclerosis (ALS).

5. nature.com nature.com/articles/s41598-024-84728-y

Artificial intelligence empowered voice generation for ... This study aims to assess the effectiveness and the perceptual impact of AI-generated voices on ALS patients with preserved speech.

6. withpower.com withpower.com/trial/phase-motor-neuron-disease-3-2024-98aaa

Communication Strategies for ALS Research has shown that communication treatments like Clear Speech and Communicative Interaction are safe for people with ALS. Previous studies aimed to help ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/condition/160/amyotrophic-lateral-sclerosis-als

Amyotrophic Lateral Sclerosis Als Clinical Research Trials This is a randomized double-blind controlled exploratory clinical study to evaluate the efficacy and safety of FB1006 in the treatment of amyotrophic lateral ...

8. policylab.us policylab.us/clinical-trials/l/conditions/amyotrophic-lateral-sclerosis?page=3

Amyotrophic Lateral Sclerosis Clinical Trials & Research Studies ... The goal of this clinical trial is to learn about the effect of communicative interaction on verbal communication in people with amyotrophic lateral sclerosis ( ...