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Treatment for Speech and Language in Primary Progressive Aphasia

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ClinicalTrials.gov Identifier: NCT04881617
Recruitment Status : Recruiting
First Posted : May 11, 2021
Last Update Posted : May 11, 2021
Sponsor:
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of California, San Francisco
Information provided by (Responsible Party):
University of Texas at Austin

Brief Summary:
Primary progressive aphasia (PPA) is a progressive neurological disorder that causes a gradual decline in communication ability as a result of selective neurodegeneration of speech and language networks in the brain. PPA is a devastating condition affecting adults as young as their 40's or 50's, depriving them of the ability to communicate and function in society. There has been significant progress in discovering the neurobiological mechanisms that underlie PPA and in identifying its clinical phenotypes. With these advances, we are poised to investigate behavioral treatments that are grounded in modern cognitive and neuroanatomical concepts. Research documenting the efficacy of speech-language treatment for PPA is emerging, but limited. Systematic research is needed to establish best clinical practices in this unique patient population for whom pharmacological treatment remains elusive. The long-term objectives of this project are to provide evidence-based treatment methods addressing the speech and language deficits in PPA and to determine the neural predictors of responsiveness to intervention. The study has three main goals that build on the findings of our previous work: 1) to examine the utility of treatments designed to facilitate significant, generalized and lasting improvement of speech-language function in PPA, 2) to determine whether treatment alters the trajectory of decline in PPA by comparing performance on primary outcome measures in treated versus untreated participants after a one-year interval, and 3) to identify imaging predictors (gray matter, white matter, and functional connectivity measures) of responsiveness to behavioral intervention in individuals with PPA. In order to accomplish these aims, we will enroll 60 individuals with PPA, who will undergo a comprehensive multidisciplinary evaluation and neuroimaging. Subsequently, participants will be enrolled in treatment designed to promote lasting and generalized improvement of communicative function in core speech-language domains. Participants will be followed for up to one-year post-treatment in order to determine long-term effects of rehabilitation, and their performance will be compared with a historical cohort of untreated PPA patients. This ambitious study and the necessary recruitment will be possible due to an ongoing collaboration with the UCSF Memory and Aging Center, a leading institution in the field of PPA research. The study will broaden the evidence base supporting the efficacy of speech-language intervention in PPA and will provide novel evidence regarding neural predictors of treatment outcomes, with the potential to inform clinical decision-making and improve clinical care for individuals with this debilitating disorder.

Condition or disease Intervention/treatment Phase
Primary Progressive Aphasia Semantic Dementia Semantic Memory Disorder Logopenic Progressive Aphasia Nonfluent Aphasia, Progressive Aphasia Aphasia, Progressive Behavioral: Lexical Retrieval Training (LRT) Behavioral: Video-Implemented Script Training for Aphasia (VISTA) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Establishing Evidence-based Treatment for Speech and Language in Primary Progressive Aphasia
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022


Arm Intervention/treatment
Experimental: Lexical Retrieval Treatment Behavioral: Lexical Retrieval Training (LRT)
In person or via teletherapy: Participants work on producing spoken and written names of personally relevant target items using a self-cueing hierarchy. Treatment focuses on the use of strategies that capitalize on spared cognitive-linguistic abilities to support word retrieval. The participant completes two (one hour each) sessions per week with a clinician plus daily home practice exercises.

Experimental: Script Training Behavioral: Video-Implemented Script Training for Aphasia (VISTA)
In person or via teletherapy: Participants work on producing personally relevant scripts of 4-6 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 target clear and accurate script production, script memorization, and conversational usage of scripts.




Primary Outcome Measures :
  1. Change in spoken naming of target items [ Time Frame: change from pre-treatment to post-treatment (approximately 8-12 weeks after treatment onset) and follow-ups at 3 months post-treatment, 6 months post-treatment, and 12 months post-treatment ]
    Change in percent correctly named trained/untrained pictures

  2. Change in script production accuracy [ Time Frame: change from pre-treatment to post-treatment (approximately 6 weeks after treatment onset) and follow-ups at 3 months post-treatment, 6 months post-treatment, and 12 months post-treatment ]
    Change in percent correct intelligible, scripted words for trained/untrained scripts


Secondary Outcome Measures :
  1. Change on Western Aphasia Battery, Revised [ Time Frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment, 6 months post-treatment, and 12 months post-treatment ]
    change on standardized aphasia assessment

  2. Change on Mini Mental State Exam [ Time Frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment, 6 months post-treatment, and 12 months post-treatment ]
    change on cognitive screen

  3. Change on Boston Naming Test [ Time Frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment, 6 months post-treatment, and 12 months post-treatment ]
    change on standardized word retrieval assessment

  4. Change on Northwestern Assessment of Verbs and Sentences [ Time Frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment, 6 months post-treatment, and 12 months post-treatment ]
    change on standardized assessment of verb and sentence processing in aphasia

  5. Change on Communicative Effectiveness Index [ Time Frame: change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) ]
    change on measure of functional communication for individuals with aphasia


Other Outcome Measures:
  1. Post-treatment Communication Survey [ Time Frame: post-treatment (approximately 6-12 weeks after treatment onset) ]
    survey characterizing perceived response to treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meets diagnostic criteria for Primary Progressive Aphasia (PPA; Gorno-Tempini et al., 2011)
  • Score of 15 or higher on the Mini-Mental State Examination

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 15 on the Mini-Mental State Examination
  • Prominent initial non-speech-language impairment (cognitive, behavioral, motoric)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04881617


Contacts
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Contact: Maya L Henry, PhD 512-471-7720 maya.henry@austin.utexas.edu
Contact: Karinne Berstis, MS 512-471-3420 aphasialab@austin.utexas.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Carly Miller, MS    415-353-3800    carly.miller@ucsf.edu   
Contact    415-353-3800      
Sub-Investigator: Maria Luisa Gorno Tempini, MD, PhD         
United States, Texas
University of Texas Recruiting
Austin, Texas, United States, 78712
Contact: Maya L Henry, PhD    512-471-7720    maya.henry@austin.utexas.edu   
Contact: Karinne Berstis, MS    512-471-3420    aphasialab@austin.utexas.edu   
Principal Investigator: Maya L Henry, PhD         
Sponsors and Collaborators
University of Texas at Austin
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of California, San Francisco
Investigators
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Principal Investigator: Maya L Henry, PhD University of Texas, Austin
Additional Information:
Publications:
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Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT04881617    
Other Study ID Numbers: R01DC016291 ( U.S. NIH Grant/Contract )
R01DC016291 ( U.S. NIH Grant/Contract )
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aphasia
Memory Disorders
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Aphasia, Broca
Primary Progressive Nonfluent Aphasia
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases