Intention Treatment for Anomia

Stroke Clinical Trial

Official title:

Intention Treatment for Anomia: Investigating Dose Frequency Effects and Predictors of Treatment Response to Improve Efficacy and Clinical Translation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04267198
• Other study ID #: N3093-R
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: Amy D Rodriguez, PhD
• Phone: (404) 321-6111
• Email: amy.rodriguez[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

Behavioral:
• Intention Treatment for Anomia
Word retrieval treatment for aphasia that engages right hemisphere intention mechanisms using a left-hand circular gesture.

Locations

Country	Name	City	State
United States	Atlanta VA Medical and Rehab Center, Decatur, GA	Decatur	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Western Aphasia Battery	This standardized assessment will be administered at baseline to investigate language predictors of treatment outcome	Baseline
Primary	Boston Naming Test	This standardized assessment will be administered at baseline to investigate language predictors of treatment outcome	Baseline
Primary	Test of Everyday Attention	This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.	Baseline
Primary	Brief Visuospatial Memory Test-Revised	This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.	Baseline
Primary	Hopkins Verbal Learning Test-Revised	This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.	Baseline
Primary	Digit Span Backwards	This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.	Baseline
Primary	Delis?Kaplan Executive Function System (D-KEFS) Sorting	This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.	Baseline
Primary	Structural MRI scan	Tissue health (from structural scan) will be obtained at baseline to investigate neural predictors of treatment outcome.	Baseline
Primary	Functional MRI scan	Task-based activation location (from functional MRI scans) will be obtained at baseline to investigate neural predictors of treatment outcome.	Baseline
Secondary	Delis?Kaplan Executive Function System (D-KEFS) Trails	This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.	Baseline