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OpenTrials
Completed

NCT Number: NCT04267198

Intention Treatment for Anomia

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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Key information

Age range

21 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intention Treatment for Anomia

Behavioral

Word retrieval treatment for aphasia that engages right hemisphere intention mechanisms using a left-hand circular gesture.

Primary outcomes

  1. Number of correctly named pictures

    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

  2. Number of correctly generated category members

    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

  3. Western Aphasia Battery

    Time frame: Baseline

    This standardized assessment will be administered at baseline to investigate language predictors of treatment outcome

  4. Boston Naming Test

    Time frame: Baseline

    This standardized assessment will be administered at baseline to investigate language predictors of treatment outcome

  5. Test of Everyday Attention

    Time frame: Baseline

    This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.

  6. Brief Visuospatial Memory Test-Revised

    Time frame: Baseline

    This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.

  7. Hopkins Verbal Learning Test-Revised

    Time frame: Baseline

    This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.

  8. Digit Span Backwards

    Time frame: Baseline

    This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.

  9. Delis-Kaplan Executive Function System (D-KEFS) Sorting

    Time frame: Baseline

    This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.

  10. Structural MRI scan

    Time frame: Baseline

    Tissue health (from structural scan) will be obtained at baseline to investigate neural predictors of treatment outcome.

  11. Functional MRI scan

    Time frame: Baseline

    Task-based activation location (from functional MRI scans) will be obtained at baseline to investigate neural predictors of treatment outcome.

Secondary outcomes

  1. Delis-Kaplan Executive Function System (D-KEFS) Trails

    Time frame: Baseline

    This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2020
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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