- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06211374
Communication Bridge Pilot Study (CB3_1)
Communication Bridge: Optimizing an Evidence-based Intervention for Individuals With Primary Progressive Aphasia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to evaluate the effectiveness and feasibility of evidence-based interventions in individuals living with mild to moderate primary progressive aphasia (PPA) that address communication-focused outcomes. The study team aims to enhance the personal relevance and therapeutic impact of goal attainment scaling (GAS) while building self-efficacy within a self-management framework.
This study will be a continuation of one of the largest non-pharmacologic intervention studies for individuals with PPA to date. It will add critical information regarding the effectiveness of telepractice interventions for communication disorders in adults with primary progressive aphasia specifically, and in dementia more broadly. The goal of this study is to maximize functional communication and life participation for the participants.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago - American School Building
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria (person with PPA):
- 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)
- Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)
- Adequate vision (aided or unaided) for reading a newspaper, or other functional materials (by self-report)
- Able to pass technology screening and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)
- Geriatric Depression Scale score ≤ 9
- Mild-moderate PPA informed by a structured interview with a speech-language pathologist and a standardized testing battery.
Inclusion Criteria (Co-enrolled communication partner):
- 18+ years of age
- English as primary language used in daily communication activities (by self-report)
- Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)
- Able to pass technology screening* and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)
Exclusion Criteria:
- A dementia diagnosis other than Primary Progressive Aphasia
- Participation is co-enrolled in an outside speech language therapy program during the study course.
- Communication partners will be excluded if they have a pre-existing communication impairment that would affect study participation (e.g., aphasia, dementia) Medical records will be requested and reviewed to determine eligibility
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Communication Bridge™
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.
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Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Communication Participation Person Centered Goals
Time Frame: Time Frame: 2 assessment time points through study completion, an average of 5 months, including change over time
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Goal Attainment Scaling, a 7-point rating scale with -3 representing 'no longer participating' and +3 representing 'exceeded goal'.
Higher scores indicate better progress in goal achievement.
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Time Frame: 2 assessment time points through study completion, an average of 5 months, including change over time
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emily Roglaski, PhD, Professor of Neurology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Metabolic Diseases
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Dementia
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Communication Disorders
- Language Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Aphasia
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
Other Study ID Numbers
- IRB23-1620
- 7R01AG055425-07 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Progressive Aphasia
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Maya HenryNational Institutes of Health (NIH); National Institute on Aging (NIA)RecruitingSemantic Dementia | Logopenic Progressive Aphasia | Nonfluent Aphasia, Progressive | Logopenic Variant Primary Progressive Aphasia | Semantic Variant Primary Progressive Aphasia (svPPA) | Nonfluent Variant Primary Progressive Aphasia (nfvPPA) | Progressive Aphasia | Logopenic Progressive Aphasia... and other conditionsUnited States
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Maya HenryNational Institute on Aging (NIA)RecruitingLogopenic Variant Primary Progressive Aphasia | Progressive Aphasia | Logopenic Progressive Aphasia (LPA) | Primary Progressive Aphasia(PPA) | Logopenic Variant of Primary Progressive Aphasia (LPA) | Progressive Aphasia in Alzheimer's DiseaseUnited States
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Massachusetts General HospitalCompletedLogopenic Variant Primary Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States
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Massachusetts General HospitalNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedLogopenic Variant Primary Progressive Aphasia | Non-fluent Variant Primary Progressive Aphasia | Semantic Variant Primary Progressive AphasiaUnited States
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Johns Hopkins UniversityNational Institute on Aging (NIA)RecruitingPrimary Progressive Aphasia | Logopenic Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States, Canada
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Mayo ClinicNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingPrimary Progressive Aphasia | Apraxia of Speech | PPA | Non-fluent Aphasia | Primary Progressive Non-fluent AphasiaUnited States
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University of Texas at AustinUniversity of California, San Francisco; National Institute on Deafness and...Active, not recruitingPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Semantic Memory Disorder | Nonfluent Aphasia, Progressive | Aphasia, ProgressiveUnited States
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University of Texas at AustinNational Institute on Deafness and Other Communication Disorders (NIDCD)Enrolling by invitationPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Semantic Memory Disorder | Nonfluent Aphasia, Progressive | Aphasia, ProgressiveUnited States
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IRCCS San RaffaeleEnrolling by invitationPrimary Progressive Aphasia(PPA)Italy
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University of British ColumbiaTerminatedPrimary Progressive Nonfluent AphasiaCanada
Clinical Trials on Communication Bridge
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University of ChicagoNational Institute on Aging (NIA)CompletedDementia | Communication | Alzheimer Disease | Primary Progressive Aphasia | AphasiaUnited States
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University of ChicagoNational Institute on Aging (NIA); Western University, CanadaRecruiting
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University of ChicagoNational Institute on Aging (NIA)Completed
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Centre Hospitalier Universitaire, AmiensCentre Hospitalier de BeauvaisCompleted
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Queen Mary University of LondonWithdrawn
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The Affiliated Hospital of Qingdao UniversityCompleted
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NYU Langone HealthWithdrawnDistal Radius FractureUnited States
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VA Office of Research and DevelopmentCompleted
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MicroPort NeuroTech Co., Ltd.RecruitingBrain Diseases | Vertebral Artery Stenosis | Vertebral Artery ThrombosisChina
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Middle East North Africa Stroke and Interventional...Not yet recruitingCerebral Venous Sinus ThrombosisEgypt, Pakistan, Saudi Arabia, Jordan, Morocco, Qatar, Tunisia, Turkey (Türkiye)