Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004, United States
NCT Number: NCT04267198
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.
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Notify Me21 year–89 year
All sexes
Interventional
Not applicable
Decatur, Georgia, 30033-4004, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Word retrieval treatment for aphasia that engages right hemisphere intention mechanisms using a left-hand circular gesture.
Time frame: 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
Change in the ability to correctly name 10 trained and 10 untrained pictures will be measured at 4 time points
Time frame: 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
Change in the ability to correctly name 5 trained and 5 untrained category members will be measured at 4 time points
Time frame: Baseline
This standardized assessment will be administered at baseline to investigate language predictors of treatment outcome
Time frame: Baseline
This standardized assessment will be administered at baseline to investigate language predictors of treatment outcome
Time frame: Baseline
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Time frame: Baseline
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Time frame: Baseline
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Time frame: Baseline
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Time frame: Baseline
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Time frame: Baseline
Tissue health (from structural scan) will be obtained at baseline to investigate neural predictors of treatment outcome.
Time frame: Baseline
Task-based activation location (from functional MRI scans) will be obtained at baseline to investigate neural predictors of treatment outcome.
Time frame: Baseline
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
VA Office of Research and Development
Fed
Intention Treatment for Anomia: Investigating Dose Frequency Effects and Predictors of Treatment Response to Improve Efficacy and Clinical Translation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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