Speech-Language Therapy for Primary Progressive Aphasia

(CB3 Trial)

Overseen By Emily Cummings

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Chicago

Disqualifiers: Dementia, Outside therapy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: Approximately 17 months

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will use a randomized controlled trial design to evaluate the effect of two evidence-based treatments for adults with mild-moderate Primary Progressive Aphasia (PPA). The aim of the study is to help us better understand the effects of speech-language therapy on communication abilities in individuals with PPA.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Communication Bridge™ for primary progressive aphasia?

Research indicates that speech-language therapy, including the Communication Bridge Care Model, can help improve communication and quality of life for individuals with primary progressive aphasia. This model uses a person-centered approach with strategies to enhance communication and participation in daily activities, supported by evidence from similar interventions. ^{1 2 3 4 5}

Is speech-language therapy safe for people with primary progressive aphasia?

Speech-language therapy, including approaches like the Communication Bridge model, is generally considered safe for people with primary progressive aphasia. It focuses on improving communication and quality of life without known harmful effects. ^{1 2 3 5 6}

How is the Communication Bridge™ treatment different from other treatments for primary progressive aphasia?

Communication Bridge™ is unique because it combines evidence-based impairment-focused therapy with a person-centered approach, aiming to preserve communication skills and independence while anticipating future decline. Unlike other treatments, it emphasizes both restitutive and compensatory techniques, along with training communication partners to facilitate better conversations, making it a comprehensive and holistic approach to managing primary progressive aphasia. ^{1 2 3 4 7}

Research Team

Emily Roglaski, PhD

Principal Investigator

Professor of Neurology

Eligibility Criteria

This trial is for adults with mild to moderate Primary Progressive Aphasia (PPA), including conditions like Pick's Disease and Frontotemporal Dementia. Participants should be able to engage in speech-language therapy.

Inclusion Criteria

I can hear well enough to talk with others in a noisy place.

Meets diagnostic criteria for PPA based on neurologist and supporting medical assessments (extracted from medical records)

English as primary language used in daily communication activities (by self-report)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 20 speech therapy sessions and access to the Communication Bridge web application

Approximately 17 months

Up to 10 evaluations and 20 therapy sessions

Follow-up

Participants are monitored for changes in communication participation and caregiver burden

Up to 18 months

5 assessment time points

Treatment Details

Interventions

• Communication Bridge™
• Evidence-Based Impairment Focused

Trial Overview The study compares two evidence-based speech-language therapies using a randomized controlled design, aiming to understand their impact on communication abilities in individuals with PPA.

Participant Groups

Group I: Communication Bridge™ Experimental Treatment 1 Intervention

Participants receive Communication Bridge™, a multi-component, participation-focused, dyadic intervention in which both the person with PPA and their co-enrolled communication partner are intervention recipients. Communication Bridge™ is modelled on the Living with Aphasia: Framework for Outcome Measurement (A-FROM) and the Care Pathway Model that was developed for persons living with primary progressive aphasia. Consistent with participation-focused intervention models personally salient training stimuli are incorporated into all therapy activities in the Experimental arm.

Group II: Evidence-Based Impairment Focused Active Control 1 Intervention

The Control arm includes a non-dyadic intervention in which the person with PPA is the active intervention recipient and their communication partner is in a supporting role. In the Control arm, participants receive a speech-language intervention designed to address impairment and functional limitations, comprised of activities that address word retrieval and 'automatic' speech production using fixed, non-personalized, stimuli across participants.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Western University, Canada

Collaborator

Trials

270

Recruited

62,500+

Findings from Research

The study developed a comprehensive training program called 'Better Conversations with primary progressive aphasia' for speech and language therapists, which includes seven online modules and a manual for communication partner training, based on extensive stakeholder consultation and co-production.

Key components of the training were identified, such as the use of video feedback and understanding the timing of interventions, which were informed by focus groups with individuals affected by primary progressive aphasia and their families, ensuring the program is tailored to their needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Medical Research Council framework and public involvement in the development of a communication partner training intervention for people with primary progressive aphasia (PPA): Better Conversations with PPA. Volkmer, A., Spector, A., Swinburn, K., et al.[2021]

Speech-language treatment approaches for primary progressive aphasia (PPA) have shown effectiveness in preserving communication abilities, with methods including restitutive, compensatory, and communication partner-focused techniques.

These interventions not only aim to rebuild lost communication skills but also enhance functional communication and social engagement, suggesting that they should become standard care practices for individuals with PPA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral interventions for primary progressive aphasia. Robinaugh, G., Henry, ML.[2022]

Speech-language pathologists (SLPs) play a crucial role in improving communication for individuals with primary progressive aphasia (PPA), yet their contributions are often underrecognized and referral rates remain low.

The E3BP model highlights that effective SLP interventions for PPA are supported by research-based evidence, practice-based evidence, and patient preferences, ensuring that treatments are both evidence-based and centered around the patient's needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Evidence-Based Practice (E3BP) Informs Speech-Language Pathology for Primary Progressive Aphasia. Ruggero, L., Croot, K., Nickels, L.[2020]

The study explored the combination of Verb Network Strengthening Treatment (VNeST) with anodal transcranial direct current stimulation (tDCS) in three individuals with primary progressive aphasia (PPA), showing that this approach may enhance language therapy outcomes.

While no overall advantage for trained verbs was observed, two participants experienced improved naming of untrained verbs and one showed enhanced sentence production, suggesting that tDCS may help generalize language improvements beyond targeted training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation Paired With Verb Network Strengthening Treatment Improves Verb Naming in Primary Progressive Aphasia: A Case Series. Sheppard, SM., Goldberg, EB., Sebastian, R., et al.[2023]

The Communication Bridge Care Model is designed to enhance communication and quality of life for individuals with primary progressive aphasia (PPA) through person-centered care and tailored communication strategies.

This multicomponent approach incorporates technology and focuses on maximizing functional communication, offering practical applications across various treatment settings to support individuals with PPA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Life Participation Approach to Primary Progressive Aphasia Intervention. Rogalski, EJ., Khayum, B.[2020]

An iterative implementation intervention for Communication Partner Training (CPT) significantly improved healthcare professionals' communication with people with aphasia (PWA), particularly in the second group that received tailored modifications based on feedback from the first group.

The study highlighted the importance of incorporating stakeholder input and addressing barriers to implementation, suggesting that ongoing support and tailored strategies can enhance the effectiveness of CPT in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering an iterative Communication Partner Training programme to multidisciplinary healthcare professionals: A pilot implementation study and process evaluation. Shrubsole, K., Lin, TJ., Burton, C., et al.[2021]

A study involving 20 patients with primary progressive aphasia (PPA) showed that those receiving speech and language therapy (SLT) for 1 hour per week over 11 months had significant improvements in naming ability compared to a control group.

The results indicate that SLT may be beneficial for patients with PPA, warranting further investigation through a randomized, controlled clinical trial to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speech therapy in primary progressive aphasia: a pilot study. Farrajota, L., Maruta, C., Maroco, J., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Using the Medical Research Council framework and public involvement in the development of a communication partner training intervention for people with primary progressive aphasia (PPA): Better Conversations with PPA. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioral interventions for primary progressive aphasia. [2022]

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

How Evidence-Based Practice (E3BP) Informs Speech-Language Pathology for Primary Progressive Aphasia. [2020]

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

Transcranial Direct Current Stimulation Paired With Verb Network Strengthening Treatment Improves Verb Naming in Primary Progressive Aphasia: A Case Series. [2023]

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

A Life Participation Approach to Primary Progressive Aphasia Intervention. [2020]

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

Delivering an iterative Communication Partner Training programme to multidisciplinary healthcare professionals: A pilot implementation study and process evaluation. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Speech therapy in primary progressive aphasia: a pilot study. [2022]