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Intention Treatment for Anomia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04267198
Recruitment Status : Not yet recruiting
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Aphasia Stroke Behavioral: Intention Treatment for Anomia Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Delayed-start controlled trial with stratification across two groups (massed-INT, distributed-INT) based on severity of word retrieval deficits.
Masking: Single (Outcomes Assessor)
Masking Description: Assessments will be conducted by study staff blind to treatment condition
Primary Purpose: Treatment
Official Title: Intention Treatment for Anomia: Investigating Dose Frequency Effects and Predictors of Treatment Response to Improve Efficacy and Clinical Translation
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Active Comparator: Massed Intention Treatment (massed-INT)
Participants will receive 30 hours of Intention Treatment (INT) over 3 weeks.
Behavioral: Intention Treatment for Anomia
Word retrieval treatment for aphasia that engages right hemisphere intention mechanisms using a left-hand circular gesture.

Active Comparator: Distributed Intention Treatment (distributed-INT)
Participants will receive 30 hours of Intention Treatment (INT) over 12 weeks.
Behavioral: Intention Treatment for Anomia
Word retrieval treatment for aphasia that engages right hemisphere intention mechanisms using a left-hand circular gesture.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267198


Contacts
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Contact: Amy D Rodriguez, PhD (404) 321-6111 ext 204201 amy.rodriguez@va.gov
Contact: Laura Britan Lang, MPH (404) 321-6111 ext 7027 Laura.Britan_Lang@va.gov

Locations
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United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
Contact: Amy D Rodriguez, PhD    404-321-6111 ext 204201    amy.rodriguez@va.gov   
Principal Investigator: Amy D. Rodriguez, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Amy D. Rodriguez, PhD Atlanta VA Medical and Rehab Center, Decatur, GA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04267198    
Other Study ID Numbers: N3093-R
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
aphasia
language
rehabilitation
speech-language pathology
Additional relevant MeSH terms:
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Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms