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

Trial Summary

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 data supports the effectiveness of the treatment Structured Communicative Interaction and Unstructured Communicative Interaction for ALS?

The research highlights the importance of timely communication support for ALS patients, as many experience severe speech difficulties. Augmentative and alternative communication (AAC) interventions are crucial, and their acceptance has increased, suggesting that structured communication strategies may help address communication needs in ALS. ^{1 2 3 4 5}

How does the treatment 'Communicative Interaction for ALS' differ from other treatments for ALS?

This treatment focuses on enhancing communication between people with ALS and their partners through structured and unstructured interactions, which is unique compared to other treatments that primarily address physical symptoms. It emphasizes the use of augmentative and alternative communication (AAC) strategies to maintain social connections and effectively convey important information, which is crucial for individuals with speech impairments due to ALS. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Communication disorder in amyotrophic lateral sclerosis after ventilation--a proposal of staging and a study of predictive factor]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Communication Support for People with ALS. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Outcome measures for early phase clinical trials. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Compliance with recommendations made in a multidisciplinary ALS clinic. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Inter-evaluator reliability of the ALS functional rating scale. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Characterizing social communication changes in amyotrophic lateral sclerosis. [2018]

7. United States 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. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Handwriting-in-interaction between people with ALS/MND and their conversation partners. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Purposes of AAC device use for persons with ALS as reported by caregivers. [2018]

10. England pubmed.ncbi.nlm.nih.gov

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