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Dosage and Predictors of Naming Treatment Response in Aphasia

Primary Purpose

Aphasia, Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Naming therapy
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 Therapy, Acquired Language Disorders, Semantics, Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All study participants will be community-dwelling adults with aphasia.
  • Both Veterans and non-Veterans who are able to arrange daily transportation to and from the campus of the VA Pittsburgh Healthcare System (VAPHS), and who do not require housing, may be eligible to be study participants.

  • In addition, Veterans who are accepted into the Program for Intensive Residential Aphasia Treatment and Education (PIRATE) of VAPHS may be eligible to participate.

    • PIRATE participants are Veterans who are referred nationally to VAPHS.
    • Aphasia diagnosis is provided by the referring medical provider, based on performance on standardized aphasia-assessment measures, and will be verified by PIRATE staff prior to enrollment. Diagnosis will be based on clinical impression and performance on the Comprehensive Aphasia Test (CAT).

Study participants must also meet the following inclusion criteria:

  • 18 years of age or older
  • Eligible for participation in the standard PIRATE program
  • Aphasia due to unilateral left hemisphere stroke equal to or more than 6 months post onset
  • Overall CAT mean language modality t-score of less than or equal to 70
  • CAT naming modality t-score greater than or equal to 40
  • No progressive neurological disease or prior central nervous system injury/disorder
  • No severe motor speech disorders (apraxia and/or dysarthria)
  • Learned English as a first language
  • Investigators able to construct lists of sufficient treatment targets and generalization probes based on performance on naming assessments

Exclusion Criteria:

Since all study candidates must be present on the VAPHS campus for treatment, and must undergo intensive speech-language therapy (up to 5 hours per day for 4 weeks), the following exclusionary criteria apply to all participants:

  • Inability to carry out activities of daily living necessary for self-care during the time they are present on the VAPHS campus
  • Lack of physical independence which would interfere with their ability to be present on the VAPHS campus
  • History of progressive neurological disease
  • History of drug or alcohol dependence that is not currently stable/medically managed
  • Inability to tolerate intensive treatment as determined by previous therapy experiences and tolerance of the intensive initial evaluation (2 days of testing)

In addition, participants who are enrolling in the study through the PIRATE program have the following exclusion criteria apply:

  • Inability to carry out activities of daily living necessary for self-care as determined by an occupational therapy assessment prior to program entry
  • Lack of physical independence
  • History of significant mood or behavioral disorder that is not currently stable/medically managed
  • History of progressive neurological disease
  • History of drug or alcohol dependence that is not currently stable/medically managed
  • Inability to tolerate intensive treatment as determined by previous therapy experiences and tolerance of the intensive initial evaluation (2 days of testing)
  • Medical conditions which would preclude independent living as determined by the medical assessment provided by a VAPHS physician prior to program entry

Sites / Locations

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

All study participants will be assigned to this arm of this single-arm study. Participants will receive intensive behavioral therapy intended to improve their naming (word production) ability.

Outcomes

Primary Outcome Measures

Change From Baseline in Philadelphia Naming Test Score
The Philadelphia Naming Test is a performance-based measure commonly used to assess naming (word production) ability among adults with aphasia. Participants are shown 175 pictures of common objects and asked to name each stimulus item within 30 seconds. Score range is from 0 to 175 (number out of 175 items that were correctly named), with higher scores representing better performance. Change in PNT score from entry to exit is the primary study outcome. Mean PNT change score measures treatment-related changes in naming ability.

Secondary Outcome Measures

Change From Baseline on Comprehensive Aphasia Test Modality Mean T-Score
The Comprehensive Aphasia Test (CAT) is a performance-based measure of language processing across multiple language domains commonly used to assess language-processing ability among adults with aphasia. The CAT Modality Mean T-Score represents an measurement of overall language-processing ability (aphasia severity). Scores are on a T-score scale (mean score 50, 2 SD range from 30 to 70), with higher scores representing better performance. Change in CAT score from entry to exit (secondary outcome) measures treatment-related changes in overall aphasia severity.

Full Information

First Posted
November 14, 2013
Last Updated
October 15, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02005016
Brief Title
Dosage and Predictors of Naming Treatment Response in Aphasia
Official Title
Dosage and Predictors of Naming Treatment Response in Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2013 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

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
This study examines aphasia treatment response among Veterans and non-Veterans living with aphasia. It seeks to identify cognitive and neural factors which are predictive of positive response to treatment targeting naming impairments in aphasia. It also examines the dose-response relationship for naming treatment. More broadly, it seeks to determine who aphasia therapy works best for, and how much aphasia therapy is sufficient to achieve positive treatment response.
Detailed Description
Language and communicative impairments following stroke (aphasia) affect more than 30% of stroke survivors, with an incidence of over 180,000 new cases annually. The consequences of aphasia are far reaching and can affect psychosocial adjustment, family role participation, vocational opportunities, and the ability to function independently in society. Recent estimates suggest that VHA outpatient clinics see 2000 new cases of aphasia each year, meaning that approximately 20,000 enrolled VHA patients and 100,000 United States Veterans are currently living with the condition. In response to this need, the VA Pittsburgh Healthcare System Geriatric Research, Education, and Clinical Center (GRECC) initiated the Program for Intensive Residential Aphasia Treatment and Education (PIRATE) in January 2009. PIRATE is a clinical demonstration project that provides approximately 100 hours of cognitive-linguistically oriented aphasia treatment to community dwelling Veterans over a 4-week period. PIRATE currently serves 18 Veterans per year in bi-monthly sessions. Resource limitations associated with PIRATE and aphasia treatment in general require that treatments be offered in the most cost-effective doses to those Veterans most likely to benefit from them. This treatment-effectiveness research study addresses these issues by examining the dose-response relationship for semantically-oriented naming treatment, and identifying cognitive, psycholinguistic and neuroanatomical predictors of treatment success. Study participants (n=60, over a 4-year period) will be recruited nationwide from Veterans enrolled in PIRATE. They will have their naming performance measured prior to PIRATE entry, during each week of treatment, and at program exit/follow-up. A battery of cognitive measures and structural magnetic resonance images of their brains will also be collected prior to treatment. Participants' performance on trained and untrained lexical items and a standardized measure of naming performance will be compared across time intervals to specify the therapy amounts for which maximum treatment benefits are achieved. Their treatment outcomes will also be correlated with specific cognitive test scores and the location and extent of their brain lesions to identify cognitive and neurological markers predictive of positive treatment response. Treatment response will also be compared across participants with different psycholinguistic profiles, to determine which groups of patients show greatest benefit from semantically-oriented naming treatment. This study should provide answers to two interlocking questions: for whom is aphasia therapy most effective, and how much of it is needed to optimize treatment outcomes. These answers have the potential to set transformative new standards for how aphasia treatment is delivered within VHA and to stroke survivors with aphasia more broadly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke
Keywords
Aphasia, Language Therapy, Acquired Language Disorders, Semantics, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
All study participants will be assigned to this arm of this single-arm study. Participants will receive intensive behavioral therapy intended to improve their naming (word production) ability.
Intervention Type
Behavioral
Intervention Name(s)
Naming therapy
Other Intervention Name(s)
Semantic feature analysis
Intervention Description
Participants will receive behavioral therapy which is designed to stimulate semantic (meaning) representations which are required for successful naming (word production). Therapy will be administered for 4 weeks on an intensive schedule (5 days a week, approximately 4.5 hours per day).
Primary Outcome Measure Information:
Title
Change From Baseline in Philadelphia Naming Test Score
Description
The Philadelphia Naming Test is a performance-based measure commonly used to assess naming (word production) ability among adults with aphasia. Participants are shown 175 pictures of common objects and asked to name each stimulus item within 30 seconds. Score range is from 0 to 175 (number out of 175 items that were correctly named), with higher scores representing better performance. Change in PNT score from entry to exit is the primary study outcome. Mean PNT change score measures treatment-related changes in naming ability.
Time Frame
Baseline (at study entry) to the day after completion of intervention (after 4 weeks of behavioral therapy).
Secondary Outcome Measure Information:
Title
Change From Baseline on Comprehensive Aphasia Test Modality Mean T-Score
Description
The Comprehensive Aphasia Test (CAT) is a performance-based measure of language processing across multiple language domains commonly used to assess language-processing ability among adults with aphasia. The CAT Modality Mean T-Score represents an measurement of overall language-processing ability (aphasia severity). Scores are on a T-score scale (mean score 50, 2 SD range from 30 to 70), with higher scores representing better performance. Change in CAT score from entry to exit (secondary outcome) measures treatment-related changes in overall aphasia severity.
Time Frame
Baseline (at study entry) to the day after completion of intervention (after 4 weeks of behavioral therapy).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All study participants will be community-dwelling adults with aphasia. Both Veterans and non-Veterans who are able to arrange daily transportation to and from the campus of the VA Pittsburgh Healthcare System (VAPHS), and who do not require housing, may be eligible to be study participants. In addition, Veterans who are accepted into the Program for Intensive Residential Aphasia Treatment and Education (PIRATE) of VAPHS may be eligible to participate. PIRATE participants are Veterans who are referred nationally to VAPHS. Aphasia diagnosis is provided by the referring medical provider, based on performance on standardized aphasia-assessment measures, and will be verified by PIRATE staff prior to enrollment. Diagnosis will be based on clinical impression and performance on the Comprehensive Aphasia Test (CAT). Study participants must also meet the following inclusion criteria: 18 years of age or older Eligible for participation in the standard PIRATE program Aphasia due to unilateral left hemisphere stroke equal to or more than 6 months post onset Overall CAT mean language modality t-score of less than or equal to 70 CAT naming modality t-score greater than or equal to 40 No progressive neurological disease or prior central nervous system injury/disorder No severe motor speech disorders (apraxia and/or dysarthria) Learned English as a first language Investigators able to construct lists of sufficient treatment targets and generalization probes based on performance on naming assessments Exclusion Criteria: Since all study candidates must be present on the VAPHS campus for treatment, and must undergo intensive speech-language therapy (up to 5 hours per day for 4 weeks), the following exclusionary criteria apply to all participants: Inability to carry out activities of daily living necessary for self-care during the time they are present on the VAPHS campus Lack of physical independence which would interfere with their ability to be present on the VAPHS campus History of progressive neurological disease History of drug or alcohol dependence that is not currently stable/medically managed Inability to tolerate intensive treatment as determined by previous therapy experiences and tolerance of the intensive initial evaluation (2 days of testing) In addition, participants who are enrolling in the study through the PIRATE program have the following exclusion criteria apply: Inability to carry out activities of daily living necessary for self-care as determined by an occupational therapy assessment prior to program entry Lack of physical independence History of significant mood or behavioral disorder that is not currently stable/medically managed History of progressive neurological disease History of drug or alcohol dependence that is not currently stable/medically managed Inability to tolerate intensive treatment as determined by previous therapy experiences and tolerance of the intensive initial evaluation (2 days of testing) Medical conditions which would preclude independent living as determined by the medical assessment provided by a VAPHS physician prior to program entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael W Dickey, PhD
Organizational Affiliation
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.pittsburgh.va.gov/PIRATE/
Description
Click here for more information about this study: Dosage and Predictors of Naming Treatment Response in Aphasia

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Dosage and Predictors of Naming Treatment Response in Aphasia

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