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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two types of speech-language therapy can improve communication for individuals with Primary Progressive Aphasia (PPA), a condition that gradually affects language skills. One group will receive "Communication Bridge™" therapy, involving both the person with PPA and a communication partner, while the other group will engage in traditional impairment-focused therapy. Candidates include those with mild to moderate PPA who speak English daily and have good hearing and vision. Participants must also be comfortable using video conferencing and a specific web application. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that the Communication Bridge™ program is safe and well-tolerated. It improves communication skills for people with primary progressive aphasia (PPA) and their partners. Participants in these studies reported positive experiences without significant side effects.

Research into various speech-language therapies, including the Evidence-Based Impairment Focused approach, shows they are generally safe for people with PPA. These therapies aim to enhance language skills and have not been linked to major negative effects.

Both treatments aim to help those with PPA communicate better, and studies suggest they are safe options for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for primary progressive aphasia because they offer a fresh approach to therapy. Unlike traditional speech-language therapies that often focus solely on the individual, Communication Bridge™ involves both the person with aphasia and their communication partner, making it a dyadic and participation-focused intervention. This method personalizes therapy by integrating personally relevant stimuli, which could enhance engagement and outcomes. On the other hand, the Evidence-Based Impairment Focused approach targets specific language impairments with structured, non-personalized activities, providing a controlled environment to address word retrieval and automatic speech production. Both treatments aim to offer new hope for improved communication in individuals with this challenging condition.

What evidence suggests that this trial's treatments could be effective for Primary Progressive Aphasia?

Research shows that Communication Bridge™, a treatment in this trial, could benefit people with Primary Progressive Aphasia (PPA). This therapy focuses on the individual and uses online sessions to help those with mild to moderate PPA enhance their communication. Other studies have found positive results with this approach, suggesting it can boost communication skills. Additionally, the Evidence-Based Impairment Focused treatment, another option in this trial, targets specific language skills like word retrieval. This method aims to improve both language difficulties and everyday communication, helping participants speak and communicate more effectively. Evidence supports both treatments in this trial as potentially effective aids for communication in people with PPA. ^{1 2 3 5 6}

Who Is on the Research Team?

Emily Roglaski, PhD

Principal Investigator

Professor of Neurology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11947768/

A randomized controlled trial of communication intervention Here, outcomes are provided from Communication Bridge‐2 (CB2), a speech‐language randomized controlled trial (RCT) for PPA. METHODS. CB2 is the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40145390/

Efficacy of Communication Bridge-2 for primary progressive ... Outcomes demonstrate the feasibility and initial efficacy of a person-centered telemedicine intervention for maximizing communication participation for mild-to ...

3. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.14168

Communication Bridge‐2 randomized controlled trial ... This trial provides a potential model for conducting rigorous non-pharmacologic efficacy trials for Alzheimer's disease and related dementias.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06191198

NCT06191198 | Communication Bridge 3 Study This study will use a randomized controlled trial design to evaluate the effect of two evidence-based treatments for adults with mild-moderate Primary ...

5. theaftd.org theaftd.org/posts/1ftd-in-the-news/blog-ppa-telehealth-comm-brig/

PPA Telehealth Intervention Gets Positive Results in ... A phase 2 clinical trial evaluating a telehealth therapy intervention for primary progressive aphasia (PPA) published positive results.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9190461/

2 (CB2): an NIH Stage 2 randomized control trial of a speech ... The CB2 trial is designed to test the central hypothesis that the Communication Bridge™ intervention is superior to the Control arm intervention for improving: ...