Treatment for Speech and Language in Primary Progressive Aphasia

Sponsor
University of Texas at Austin (Other)
Overall Status
Recruiting
CT.gov ID
NCT04881617
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH), University of California, San Francisco (Other)
60
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2
84
30
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Study Details

Study Description

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
  • Behavioral: Lexical Retrieval Training (LRT)
  • Behavioral: Video-Implemented Script Training for Aphasia (VISTA)
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jul 1, 2017
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in spoken naming of target items [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 [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 [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 [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 [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 [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 [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 [post-treatment (approximately 6-12 weeks after treatment onset)]

    survey characterizing perceived response to treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Meets diagnostic criteria for Primary Progressive Aphasia (PPA; Gorno-Tempini et al.,
  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California San Francisco San Francisco California United States 94158
2 University of Texas Austin Texas United States 78712

Sponsors and Collaborators

  • University of Texas at Austin
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • University of California, San Francisco

Investigators

  • Principal Investigator: Maya L Henry, PhD, University of Texas, Austin

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT04881617
Other Study ID Numbers:
  • R01DC016291
  • R01DC016291
First Posted:
May 11, 2021
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 25, 2022