Communication Strategies 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: Unknown

300 Participants Needed

Trial Summary

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 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Communication Strategies for ALS?

Research shows that using communication aids, like augmentative and alternative communication (AAC) devices, can help people with ALS maintain their social roles and improve communication effectiveness, as reported by both the individuals with ALS and their listeners. ^{1 2 3 4 5}

Is the communication strategy treatment for ALS safe for humans?

The research articles provided do not contain specific safety data for the communication strategy treatment for ALS or its related names. ^{3 6 7 8 9}

How does the Communication Strategies for ALS treatment differ from other treatments for ALS?

This treatment is unique because it focuses on enhancing communication between people with ALS and their partners by using structured and unstructured communicative interactions, rather than solely relying on physical speech improvements. It emphasizes the importance of joint interaction and real-life communication strategies, which are often overlooked in traditional ALS treatments. ^{3 9 10 11 12}

Research Team

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

Eligibility Criteria

This trial is for people with ALS who can still speak single words and are native American English speakers. They should have no other speech, language, or neurological issues besides ALS, no history of conditions like stroke, and must pass a cognitive assessment as well as a hearing test.

Inclusion Criteria

I am 18-40, speak only American English, and have no speech or neurological issues.

I have ALS with speech issues but no other neurological conditions or cognitive impairments.

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

Intervention

Participants engage in solo and interactive speech production tasks using tablets and audio recording devices at home

4 weeks

Remote sessions via videoconferencing

Follow-up

Participants are monitored for speech outcomes and data analysis

4 weeks

Treatment Details

Interventions

• Clear Speech
• Clear Speech Structured Communicative Interaction
• Structured Communicative Interaction
• Unstructured Communicative Interaction

Trial Overview The study examines the impact of different types of communicative interactions on verbal communication in individuals with ALS. Participants will read words and sentences alone and then in an interactive setting to compare effects.

Participant Groups

Group I: People with amyotrophic lateral sclerosis, age-matched speakers Experimental Treatment 4 Interventions

People with ALS and age-matched speakers will participate in structured communicative interaction.

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Findings from Research

Participants with amyotrophic lateral sclerosis (PALS) who used communication aids reported significantly better communicative participation compared to when they relied solely on their natural speech, especially those with severe speech impairment (anarthria).

The study highlights the importance of personalized communication strategies, as self-rated participation varied widely among PALS at similar levels of speech function, indicating that individual needs and environmental factors should be considered in communication interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Aided Communication on Communicative Participation for People With Amyotrophic Lateral Sclerosis. Peters, B., Wiedrick, J., Baylor, C.[2023]

A systematic review of 15 articles identified only 6 studies that met the criteria for evaluating interventions for adults with social communication impairments due to Acquired Brain Injury, highlighting a lack of robust evidence in this area.

The studies varied widely in their design and intervention approaches, with no clear consensus on the most effective treatment, indicating a need for further research with larger sample sizes and better methodologies to establish effective clinical guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of interventions for adults with social communication impairments due to an acquired brain injury: Significant other reports. Paice, L., Aleligay, A., Checklin, M.[2021]

Speakers with amyotrophic lateral sclerosis (ALS) and their listeners reported similar perceptions of communication effectiveness across various social situations, indicating a shared understanding of communication challenges.

The study identified specific social contexts that are particularly difficult for effective communication for individuals with ALS, which can inform strategies for better support and counseling for patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication effectiveness of individuals with amyotrophic lateral sclerosis. Ball, LJ., Beukelman, DR., Pattee, GL.[2015]

The eye-tracking computer system (ETCS) is an effective communication tool for patients with late-stage ALS, with an average daily usage of 300 minutes for activities like communicating and internet use.

However, about 23.3% of patients experienced low utilization of the ETCS, primarily due to eye-gaze fatigue and oculomotor dysfunction, which can limit its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The eye-tracking computer device for communication in amyotrophic lateral sclerosis. Spataro, R., Ciriacono, M., Manno, C., et al.[2022]

Surviving spouses of individuals with ALS reported significant changes in communication styles as their partners transitioned to using augmentative and alternative communication (AAC) devices, highlighting the importance of these tools in facilitating communication.

AAC devices were deemed essential not only for decision-making but also for helping individuals with ALS maintain their social roles and community involvement, emphasizing the need for adaptive social activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication styles of persons with ALS as recounted by surviving partners. McKelvey, M., Evans, DL., Kawai, N., et al.[2018]

The FDA's draft guidance for ALS drug development, created with input from a diverse group of stakeholders, aims to improve the efficiency and effectiveness of clinical trials for new treatments.

Emphasizing the importance of patient engagement and experience data, the guidance suggests that further research into biomarkers and efficacy endpoints will enhance collaboration among stakeholders and streamline the drug approval process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ALS drug development guidances and trial guidelines: Consensus and opportunities for alignment. Andrews, JA., Bruijn, LI., Shefner, JM.[2020]

The REFINE-ALS study incorporated feedback from ALS patients and caregivers, leading to significant changes in the study design to address concerns about sample collection frequency, travel burden, and enrollment criteria.

As a result of this patient-centric approach, the study reduced the number of visits, optimized travel logistics, clarified entry criteria, and established plans for sharing data with participants, enhancing the overall feasibility and participant experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging ALS patients and caregivers (the ALS research ambassadors) to help design the REFINE-ALS biomarker study. Berry, JD., Bedlack, R., Mathews, D., et al.[2022]

Effective health communication in ALS care should be tailored to individual patient and caregiver needs, focusing on both medical and practical information, as identified through qualitative analysis of 105 participants in the ALS Talk Project.

Healthcare professionals are encouraged to establish and regularly update communication agreements with patients and caregivers to address their preferences and needs, which can enhance trust and facilitate discussions on sensitive topics like advance care planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do people affected by amyotrophic lateral sclerosis want from health communications? Evidence from the ALS Talk Project. Genuis, SK., Luth, W., Bubela, T., et al.[2023]

Involving people living with amyotrophic lateral sclerosis (plwALS) in focus groups revealed that anticipation, preparation, and adaptation are crucial for managing changes in communication due to ALS, highlighting the importance of partner involvement.

Future research should prioritize developing strategies and technologies for augmentative and alternative communication (AAC) that support both plwALS and their partners, focusing on their unique experiences and needs during communication changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication change in ALS: engaging people living with ALS and their partners in future research. Judge, S., Bloch, S., McDermott, CJ.[2020]

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]

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]

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]

References

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

Effects of Aided Communication on Communicative Participation for People With Amyotrophic Lateral Sclerosis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A systematic review of interventions for adults with social communication impairments due to an acquired brain injury: Significant other reports. [2021]

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

Communication effectiveness of individuals with amyotrophic lateral sclerosis. [2015]

4. Denmark pubmed.ncbi.nlm.nih.gov

The eye-tracking computer device for communication in amyotrophic lateral sclerosis. [2022]

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

Communication styles of persons with ALS as recounted by surviving partners. [2018]

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

ALS drug development guidances and trial guidelines: Consensus and opportunities for alignment. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Engaging ALS patients and caregivers (the ALS research ambassadors) to help design the REFINE-ALS biomarker study. [2022]

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

What do people affected by amyotrophic lateral sclerosis want from health communications? Evidence from the ALS Talk Project. [2023]

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

Communication change in ALS: engaging people living with ALS and their partners in future research. [2020]

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

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

11. England pubmed.ncbi.nlm.nih.gov

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

12. England pubmed.ncbi.nlm.nih.gov

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