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Intention Treatment for Anomia

Primary Purpose

Aphasia, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intention Treatment for Anomia
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring aphasia, language, rehabilitation, speech-language pathology

Eligibility Criteria

21 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Massed Intention Treatment (massed-INT)

Distributed Intention Treatment (distributed-INT)

Arm Description

Participants will receive 30 hours of Intention Treatment (INT) over 3 weeks.

Participants will receive 30 hours of Intention Treatment (INT) over 12 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Delis?Kaplan Executive Function System (D-KEFS) Trails
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.

Full Information

First Posted
February 4, 2020
Last Updated
February 7, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04267198
Brief Title
Intention Treatment for Anomia
Official Title
Intention Treatment for Anomia: Investigating Dose Frequency Effects and Predictors of Treatment Response to Improve Efficacy and Clinical Translation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2021 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke
Keywords
aphasia, language, rehabilitation, speech-language pathology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Delayed-start controlled trial with stratification across two groups (massed-INT, distributed-INT) based on severity of word retrieval deficits.
Masking
Outcomes Assessor
Masking Description
Assessments will be conducted by study staff blind to treatment condition
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Massed Intention Treatment (massed-INT)
Arm Type
Active Comparator
Arm Description
Participants will receive 30 hours of Intention Treatment (INT) over 3 weeks.
Arm Title
Distributed Intention Treatment (distributed-INT)
Arm Type
Active Comparator
Arm Description
Participants will receive 30 hours of Intention Treatment (INT) over 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Intention Treatment for Anomia
Intervention Description
Word retrieval treatment for aphasia that engages right hemisphere intention mechanisms using a left-hand circular gesture.
Primary Outcome Measure Information:
Title
Number of correctly named pictures
Description
Change in the ability to correctly name 10 trained and 10 untrained pictures will be measured at 4 time points
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
Title
Number of correctly generated category members
Description
Change in the ability to correctly name 5 trained and 5 untrained category members 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
Title
Western Aphasia Battery
Description
This standardized assessment will be administered at baseline to investigate language predictors of treatment outcome
Time Frame
Baseline
Title
Boston Naming Test
Description
This standardized assessment will be administered at baseline to investigate language predictors of treatment outcome
Time Frame
Baseline
Title
Test of Everyday Attention
Description
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Time Frame
Baseline
Title
Brief Visuospatial Memory Test-Revised
Description
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Time Frame
Baseline
Title
Hopkins Verbal Learning Test-Revised
Description
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Time Frame
Baseline
Title
Digit Span Backwards
Description
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Time Frame
Baseline
Title
Delis?Kaplan Executive Function System (D-KEFS) Sorting
Description
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Time Frame
Baseline
Title
Structural MRI scan
Description
Tissue health (from structural scan) will be obtained at baseline to investigate neural predictors of treatment outcome.
Time Frame
Baseline
Title
Functional MRI scan
Description
Task-based activation location (from functional MRI scans) will be obtained at baseline to investigate neural predictors of treatment outcome.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Delis?Kaplan Executive Function System (D-KEFS) Trails
Description
This standardized assessment will be administered at baseline to investigate cognitive predictors of treatment outcome.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy D Rodriguez, PhD
Phone
(404) 321-6111
Ext
204201
Email
amy.rodriguez@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Britan Lang, MPH
Phone
(404) 321-6111
Ext
7027
Email
Laura.Britan_Lang@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy D. Rodriguez, PhD
Organizational Affiliation
Atlanta VA Medical and Rehab Center, Decatur, GA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033-4004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley N Scales
Phone
404-321-6111
Ext
23952
Email
Ashley.Scales@va.gov
First Name & Middle Initial & Last Name & Degree
Laura Britan Lang, MPH
Phone
(404) 321-6111
Ext
7027
Email
Laura.Britan_Lang@va.gov
First Name & Middle Initial & Last Name & Degree
Amy D. Rodriguez, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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