Treatment for Speech and Language in Primary Progressive Aphasia

Aphasia Clinical Trial

Official title:

Establishing Evidence-based Treatment for Speech and Language in Primary Progressive Aphasia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04881617
• Other study ID #: R01DC016291
• Secondary ID: R01DC016291
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Broca
• Aphasia, Primary Progressive
• Frontotemporal Dementia
• Logopenic Progressive Aphasia
• Memory Disorders
• Nonfluent Aphasia, Progressive
• Pick Disease of the Brain
• Primary Progressive Aphasia
• Primary Progressive Nonfluent Aphasia
• Semantic Dementia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Texas	Austin	Texas
United States	University of California San Francisco	San Francisco	California

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

References & Publications (3)

Dial HR, Hinshelwood HA, Grasso SM, Hubbard HI, Gorno-Tempini ML, Henry ML. Investigating the utility of teletherapy in individuals with primary progressive aphasia. Clin Interv Aging. 2019 Feb 25;14:453-471. doi: 10.2147/CIA.S178878. eCollection 2019. — View Citation

Henry ML, Hubbard HI, Grasso SM, Dial HR, Beeson PM, Miller BL, Gorno-Tempini ML. Treatment for Word Retrieval in Semantic and Logopenic Variants of Primary Progressive Aphasia: Immediate and Long-Term Outcomes. J Speech Lang Hear Res. 2019 Aug 15;62(8):2723-2749. doi: 10.1044/2018_JSLHR-L-18-0144. Epub 2019 Aug 7. — View Citation

Henry ML, Hubbard HI, Grasso SM, Mandelli ML, Wilson SM, Sathishkumar MT, Fridriksson J, Daigle W, Boxer AL, Miller BL, Gorno-Tempini ML. Retraining speech production and fluency in non-fluent/agrammatic primary progressive aphasia. Brain. 2018 Jun 1;141(6):1799-1814. doi: 10.1093/brain/awy101. Erratum In: Brain. 2018 Jul 1;141(7):e57. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-treatment Communication Survey	survey characterizing perceived response to treatment	post-treatment (approximately 6-12 weeks after treatment onset)
Primary	Change in spoken naming of target items	Change in percent correctly named trained/untrained pictures	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
Primary	Change in script production accuracy	Change in percent correct intelligible, scripted words for trained/untrained scripts	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
Secondary	Change on Western Aphasia Battery, Revised	change on standardized aphasia assessment	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
Secondary	Change on Mini Mental State Exam	change on cognitive screen	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
Secondary	Change on Boston Naming Test	change on standardized word retrieval assessment	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
Secondary	Change on Northwestern Assessment of Verbs and Sentences	change on standardized assessment of verb and sentence processing in aphasia	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
Secondary	Change on Communicative Effectiveness Index	change on measure of functional communication for individuals with aphasia	change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset)

External Links

•   UCSF Language Neurobiology Lab
•   University of Texas Aphasia Research and Treatment Lab