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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Massed Intention Treatment (massed-INT) | Active Comparator | Participants will receive 30 hours of Intention Treatment (INT) over 3 weeks. |
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| Distributed Intention Treatment (distributed-INT) | Active Comparator | Participants will receive 30 hours of Intention Treatment (INT) over 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intention Treatment for Anomia | Behavioral | Word retrieval treatment for aphasia that engages right hemisphere intention mechanisms using a left-hand circular gesture. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of correctly named pictures | Change in the ability to correctly name 10 trained and 10 untrained pictures will be measured at 4 time points | 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 |
| Number of correctly generated category members | Change in the ability to correctly name 5 trained and 5 untrained category members will be measured at 4 time points | 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 |
| Western Aphasia Battery | This standardized assessment will be administered at baseline to investigate language predictors of treatment outcome | Baseline |
| Boston Naming Test | This standardized assessment will be administered at baseline to investigate language predictors of treatment outcome | Baseline |
| Test of Everyday Attention | This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome. | Baseline |
| Brief Visuospatial Memory Test-Revised | This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Delis-Kaplan Executive Function System (D-KEFS) Trails | This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy D. Rodriguez, PhD | Atlanta VA Medical and Rehab Center, Decatur, GA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia | 30033-4004 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 29, 2024 | May 27, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001037 | Aphasia |
| D020521 | Stroke |
| D007802 | Language |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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Delayed-start controlled trial with stratification across two groups (massed-INT, distributed-INT) based on severity of word retrieval deficits.
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Assessments will be conducted by study staff blind to treatment condition
| Hopkins Verbal Learning Test-Revised |
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome. |
| Baseline |
| Digit Span Backwards | This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome. | Baseline |
| Delis-Kaplan Executive Function System (D-KEFS) Sorting | This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome. | Baseline |
| Structural MRI scan | Tissue health (from structural scan) will be obtained at baseline to investigate neural predictors of treatment outcome. | Baseline |
| Functional MRI scan | Task-based activation location (from functional MRI scans) will be obtained at baseline to investigate neural predictors of treatment outcome. | Baseline |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003142 | Communication |
| D001519 | Behavior |