Clinical trial NCT04267198: Intention Treatment for Anomia
Official title: Intention Treatment for Anomia: Investigating Dose Frequency Effects and Predictors of Treatment Response to Improve Efficacy and Clinical Translation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aphasia
Stroke
Keywords: aphasia
language
rehabilitation
speech-language pathology
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-02-12
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Delayed-start controlled trial with stratification across two groups (massed-INT, distributed-INT) based on severity of word retrieval deficits.
Primary purpose: TREATMENT

Brief summary: Every year approximately 15,000 Veterans are hospitalized for stroke, and up to 40% of those Veterans will experience stroke-related language impairment (i.e., aphasia). Stroke-induced aphasia results in increased healthcare costs and decreased quality of life. As the population of Veterans continues to age, there will be an increasing number for Veterans living with the aphasia and its consequences. Those Veterans deserve to receive aphasia treatment designed to facilitate the best possible outcomes. In the proposed study, the investigators will investigate optimal treatment intensity and predictors of treatment response for a novel word retrieval treatment. The knowledge the investigators gain will have direct implications for the selecting the right treatment approach for the right Veteran.

Detailed description: Difficulty retrieving words is one of the most common language complaints in individuals with stroke-induced aphasia. The negative consequences related to word retrieval impairment include increased health care costs and decreased quality of life. A variety of treatment approaches exist to improve word retrieval, and most of the treatments result in immediate improvement on trained words. However, long-term improvement and improvement on untrained words or behaviors is less common. Additionally, the investigators currently know very little about optimal treatment administration parameters, and the investigators know even less about predictors of treatment response. To make the best use of the limited clinical resources available for aphasia treatment, and to maximize outcomes for Veterans with aphasia, the investigators must: 1) develop clinically translatable treatments that yield widespread and lasting effects and 2) develop clinically accessible ways of identifying who will acquire benefit from a specific treatment approach. This study takes on these two challenges by investigating dose frequency (massed vs. distributed practice) effects and by identifying the language, cognitive and neural predictors of response to Intention treatment (INT), a novel word retrieval treatment. Specifically, the investigators will address the following aims:

Aim 1: To investigate dose frequency effects on maintenance and generalization of INT gains. Outcome measure: Word retrieval accuracy for trained and untrained words.

Aim 2: To identify the language and cognitive variables that predict response to m-INT vs. d-INT. Outcome measure: Language and cognitive ability as measured by standardized assessments.

Aim 3: To identify the neural predictors of response to m-INT vs. d-INT. Outcome measure: Tissue health and task activation location as measured by structural and functional MRI.

Eligibility criteria: Inclusion Criteria:

* English as primary language
* \> 6 months post-onset a left-hemisphere stroke. Multiple strokes are acceptable as long as they are confined to the left hemisphere.
* Diagnosis of aphasia
* Presence of word retrieval deficits
* Adequate comprehension as judged by ability to complete two-step commands on the Western Aphasia Battery.

Exclusion Criteria:

* Severe apraxia of speech or dysarthria
* Clinically significant depression
* For MRI safety: implanted medical devices, metal in the body and claustrophobia.

Primary outcomes:
measure: Number of correctly named pictures
timeFrame: Through study completion, an average of 6 months; Change from baseline to 3 weeks (post massed-INT) or 12 weeks (post distributed-INT), change at 3 months post-treatment, change at 6 months post-treatment
measure: Number of correctly generated category members
timeFrame: Through study study completion, an average of 6 months; Change from baseline to 3 weeks (post m-INT) or 12 weeks (post d-INT), change at 3 months post-treatment, change at 6 months post-treatment
measure: Western Aphasia Battery
timeFrame: Baseline
measure: Boston Naming Test
timeFrame: Baseline
measure: Test of Everyday Attention
timeFrame: Baseline
measure: Brief Visuospatial Memory Test-Revised
timeFrame: Baseline
measure: Hopkins Verbal Learning Test-Revised
timeFrame: Baseline
measure: Digit Span Backwards
timeFrame: Baseline
measure: Delis-Kaplan Executive Function System (D-KEFS) Sorting
timeFrame: Baseline
measure: Structural MRI scan
timeFrame: Baseline
measure: Functional MRI scan
timeFrame: Baseline
Secondary outcomes:
measure: Delis-Kaplan Executive Function System (D-KEFS) Trails
timeFrame: Baseline
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
Study officials:
affiliation: Atlanta VA Medical and Rehab Center, Decatur, GA
name: Amy D. Rodriguez, PhD
role: PRINCIPAL_INVESTIGATOR
References: