- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06649084
Primary Progressive Aphasia Multicomponent Language Treatment Study
Establishing Evidence-based Multicomponent Treatment for Speech and Language in Primary Progressive Aphasia
The goal of this clinical trial is to learn if a speech-language telerehabilitation helps improve communication in people with primary progressive aphasia (PPA), a form of dementia that affects speech and language. The study will also document how acceptable and helpful the program is for both patients and their care partners.
The main questions the study aims to answer are:
- Is the telerehabilitation program feasible and acceptable for people with PPA and their care partners?
- Do participants with PPA and care partners report satisfaction with the program?
- Which outcome measures are most useful for evaluating changes in communication and quality of life?
- What patterns of treatment response are seen in participants after completing the program?
Researchers will test the program in a small group of participants to see how people respond. The program includes both speech-language therapy and training for care partners.
Participants will:
- Take part in online speech-language therapy sessions
- Complete communication tasks and questionnaires before and after the program
- Have regular virtual check-ins with the research team
- Include their care partners in some parts of the program for training and support
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Austin, Texas, United States, 78712
- University of Texas
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Meets diagnostic criteria for Primary Progressive Aphasia (PPA; Gorno-Tempini et al., 2011)
- Scores of 10 or higher on the Mini-Mental State Examination
- Has a study partner who can consistently attend sessions
Exclusion Criteria:
- Other neurological or psychiatric diagnosis that may contribute to cognitive-linguistic deficits
- Significant, uncorrected visual or hearing impairment that would interfere with participation
- Score of less than 10 on the Mini-Mental State Examination
- Prominent initial non-speech-language impairment (cognitive, behavioral, motoric)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Multicomponent Lexical Retrieval Training (Multi-LRT)
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In person or via teletherapy: A multi-component treatment incorporating elements of restitutive, compensatory, and care-partner focused interventions.
Participants work on producing names of personally relevant target in multiple communication modalities.
Treatment focuses on the use of strategies which capitalize on residual linguistic ability and autobiographical memory to support word retrieval.
The participant completes two one-hour-long sessions per week plus daily homework.
The participant also meets 4 times during the course of treatment with a study partner (e.g., spouse) for communication counseling, education, and practice of communication strategies.
|
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Experimental: Multicomponent Video Implemented Script Training in Aphasia (Multi-VISTA)
|
In person or via teletherapy: A multi-component treatment incorporating elements of restitutive, compensatory, and care-partner focused interventions.
Participants work on producing personally relevant scripts of 3-5 sentences in length.
Length and complexity of scripts are individually tailored.
The participant completes 30 minutes per day of home practice, during which they speak in unison with a video/audio model of a healthy speaker clearly articulating the scripts.
Biweekly (one hour each) sessions with a clinician are held which target clear and accurate script production, script memorization, and conversational usage of the script and multimodal communication.
The participant also meets 6 times during the course of treatment with a study partner (e.g., spouse) for communication counseling, education, and practice of communication strategies.
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Experimental: Experimental: Multicomponent Communicaiton Partner Training (Multi-CPT)
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In person or via teletherapy: A multi-component treatment incorporating elements of compensatory and care-partner focused interventions.
Biweekly (one hour each) sessions with a clinician are held which target use of communication strategies including multimodal communication for the participant and study partner (e.g., spouse).
The participant also completes regular assignments meant to increase generalization of communication strategies and progress on personal goals.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in script production accuracy
Time Frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
|
Percent correct intelligible, scripted words for trained/untrained scripts
|
change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
|
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Change in spoken naming of trained/untrained items
Time Frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
|
Percent correctly named trained/untrained pictures
|
change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
|
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Information communicated in any modality for trained/untrained stimuli
Time Frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
|
Percent of major content units (key words) communicated via speech or nonspeech modalities (e.g., writing, drawing, gesture) for trained/untrained scripts (Multi-VISTA) or words (Multi-LRT) during structured probes and in conversation
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change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
|
|
Goal Attainment Score
Time Frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
|
The Goal Attainment Score is self-reported progress on personalized goals based on a five point scale.
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change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change on Quick Aphasia Battery
Time Frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
|
change on standardized aphasia assessment
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change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
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Change on Aphasia Impact Questionnaire
Time Frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
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change on psychosocial questionnaire for individuals with aphasia
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change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-treatment Communication Survey
Time Frame: post-treatment (approximately 6-12 weeks after treatment onset)
|
survey characterizing perceived response to treatment
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post-treatment (approximately 6-12 weeks after treatment onset)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maya L Henry, PhD, University of Texas - Austin
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Metabolic Diseases
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Dementia
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Communication Disorders
- Language Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Aphasia
- Neurodegenerative Diseases
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Memory Disorders
- Primary Progressive Nonfluent Aphasia
Other Study ID Numbers
- R56DC016291 (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
product manufactured in and exported from the U.S.
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
-
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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Johns Hopkins UniversityNational Institute on Aging (NIA)RecruitingPrimary Progressive Aphasia | Logopenic Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States, Canada
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Massachusetts General HospitalCompletedLogopenic Variant Primary Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States
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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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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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IRCCS San RaffaeleEnrolling by invitationPrimary Progressive Aphasia(PPA)Italy
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Mayo ClinicCompletedPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Apraxia of Speech | Primary Progressive Nonfluent Aphasia | PPA | Non-fluent Aphasia | Progressive AphasiaUnited States
-
University of British ColumbiaTerminatedPrimary Progressive Nonfluent AphasiaCanada
Clinical Trials on Multicomponent Lexical Retrieval Training (Multi-LRT)
-
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
-
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 AustinHospital Clinic of Barcelona; Fundació Institut de Recerca de l'Hospital de...RecruitingNeurocognitive Disorders | Neurodegenerative Diseases | Dementia | Alzheimer Disease | Language Disorders | Communication Disorders | Primary Progressive Aphasia | Aphasia | Speech Disorders | Frontotemporal Lobar Degeneration | Dysarthria | Apraxia, Motor | Dementia, Frontotemporal | Bilingual AphasiaSpain, United States
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University of Texas at AustinUniversity of California, San FranciscoEnrolling by invitationPrimary Progressive AphasiaUnited States
-
Universidad Católica del MauleUniversidad de Los Lagos; University of TalcaActive, not recruiting