- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06191198
Communication Bridge 3 Study (CB3)
January 17, 2024 updated by: University of Chicago
Communication Bridge: Optimizing an Evidence-based Intervention for Individuals With Primary Progressive Aphasia
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Participants with a diagnosis of PPA and their actively-engaged care partners will be involved in the study for approximately 17 months.
Each participant will receive a laptop equipped with the necessary applications and features for the study.
Participants will receive up to 10 evaluations and 20 speech therapy sessions with a licensed speech therapist, as well as access to Communication Bridge, a personalized web application to practice home exercises that reinforce treatment strategies.
There are no costs to participate in this study.
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Matthew Bona, MPH
- Phone Number: 51145 773-702-1220
- Email: cbtrial@uchicago.edu
Study Contact Backup
- Name: Emily Cummings
- Phone Number: 773-702-1221
- Email: cbtrial@uchicago.edu
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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Contact:
- Matthew Bona, MPH
- Email: cbtrial@uchicago.edu
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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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Active Comparator: Evidence-Based Impairment Focused
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.
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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 |
---|---|---|
Change in Communication Participation Person Centered Goals
Time Frame: 5 assessment time points through study completion, an average of 1 year, 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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5 assessment time points through study completion, an average of 1 year, including change over time
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emily Roglaski, PhD, Professor of Neurology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2024
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Study Registration Dates
First Submitted
December 20, 2023
First Submitted That Met QC Criteria
December 20, 2023
First Posted (Actual)
January 5, 2024
Study Record Updates
Last Update Posted (Actual)
January 19, 2024
Last Update Submitted That Met QC Criteria
January 17, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Dementia
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Aphasia
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
Other Study ID Numbers
- IRB23-1175
- 7R01AG055425-07 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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Massachusetts General HospitalCompletedLogopenic Variant Primary Progressive Aphasia | Non-Fluent Primary Progressive 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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Johns Hopkins UniversityNational Institute on Aging (NIA)RecruitingPrimary Progressive Aphasia | Logopenic Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States, Canada
-
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
-
Massachusetts General HospitalNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingLogopenic Variant Primary Progressive Aphasia | Non-fluent Variant Primary Progressive Aphasia | Semantic Variant Primary Progressive AphasiaUnited States
-
Mayo ClinicCompletedPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Apraxia of Speech | Primary Progressive Nonfluent Aphasia | PPA | Non-fluent Aphasia | Progressive AphasiaUnited States
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University of British ColumbiaTerminatedPrimary Progressive Nonfluent AphasiaCanada
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Axon Neuroscience SEUnknownPrimary Progressive Nonfluent AphasiaGermany
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Montreal Heart InstituteActive, not recruitingNeurodegenerative Diseases | Primary Progressive Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Non-fluent AphasiaCanada
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Mayo ClinicRecruitingPrimary Progressive Aphasia | Apraxia of Speech | Primary Progressive Nonfluent Aphasia | Non-fluent AphasiaUnited States
Clinical Trials on Communication Bridge™
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Northwestern UniversityNational Institute on Aging (NIA)CompletedDementia | Communication | Alzheimer Disease | Primary Progressive Aphasia | AphasiaUnited States
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Northwestern UniversityNational Institute on Aging (NIA)CompletedPrimary Progressive AphasiaUnited States
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University of ChicagoNational Institute on Aging (NIA); Western University, CanadaNot yet recruiting
-
Andrew ParrentUniversity of Western Ontario, Canada; Synaptive MedicalUnknownTemporal Lobe Epilepsy
-
Masimo CorporationEnrolling by invitation
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London Health Sciences CentreUniversity of Western Ontario, Canada; Synaptive MedicalUnknownBrain Damage, Chronic | Cerebellar Cognitive Affective Syndrome | Cerebellar Mutism
-
Centre Hospitalier Universitaire, AmiensCentre Hospitalier de BeauvaisActive, not recruiting
-
MicroPort NeuroTech Co., Ltd.RecruitingBrain Diseases | Vertebral Artery Stenosis | Vertebral Artery ThrombosisChina
-
Jacques E. ChellyNational Institute on Drug Abuse (NIDA); Masimo CorporationRecruitingOpioid Use | Cancer Pain | Auriculotherapy | Pain, AbdominalUnited States
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Tau Pnu Medical Co., Ltd.CompletedFunctional Tricuspid RegurgitationKorea, Republic of