Dosage and Predictors of Naming Treatment Response in Aphasia

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02005016
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arm: 1
• Actual Duration (Months): 60
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aphasia; Stroke	Behavioral: Naming therapy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Dosage and Predictors of Naming Treatment Response in Aphasia
• Actual Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Sep 1, 2018
• Actual Study Completion Date: Sep 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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.	Behavioral: Naming therapy; 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).; Other Names: Semantic feature analysis

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Philadelphia Naming Test Score [Baseline (at study entry) to the day after completion of intervention (after 4 weeks of behavioral therapy).]

   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

1. Change From Baseline on Comprehensive Aphasia Test Modality Mean T-Score [Baseline (at study entry) to the day after completion of intervention (after 4 weeks of behavioral therapy).]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania	United States	15240

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Michael W Dickey, PhD, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 30, 2019

More Information

Additional Information:

• Click here for more information about this study: Dosage and Predictors of Naming Treatment Response in Aphasia

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02005016
• Other Study ID Numbers: O0832-R; 1I01RX000832-01A2
• First Posted: Dec 9, 2013
• Last Update Posted: Nov 4, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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 Therapy; Acquired Language Disorders; Semantics; Stroke
• Additional relevant MeSH terms: Aphasia

Study Results

Participant Flow

Arm/Group Title	Behavioral Therapy
Arm/Group 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. Naming therapy: 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).
Period Title: Overall Study
STARTED	46
COMPLETED	44
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Behavioral Therapy
Arm/Group 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. Naming therapy: 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).
Overall Participants	46
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	22 47.8%
>=65 years	22 47.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.56 (12.64)
Sex: Female, Male (Count of Participants)
Female	5 10.9%
Male	41 89.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.2%
Not Hispanic or Latino	45 97.8%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	5 10.9%
White	39 84.8%
More than one race	2 4.3%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	46 100%
Philadelphia Naming Test (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	111.96 (39.92)

Outcome Measures

1. Primary Outcome

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).

Outcome Measure Data

Analysis Population Description

The PNT was administered at two timepoints for the majority of the sample (32/44). The initial 12 participants received the PNT at study entry and abbreviated forms of the assessment during the protocol and at study exit. These abbreviated forms were found not to be reliable, so the full PNT was administered to remaining participants at exit.

Arm/Group Title	Behavioral Therapy
Arm/Group 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. Naming therapy: 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).
Measure Participants	32
Mean (Standard Error) [score on a scale]	5.91 (1.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral Therapy
	Comments
	Type of Statistical Test	Other
	Comments	This was a single-group study. A t-test was administered comparing pre- and post-treatment PNT scores (range: 1-175; higher scores are better).
Statistical Test of Hypothesis	p-Value	<0.005
	Comments
	Method	t-test, 1 sided
	Comments

2. Secondary Outcome

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).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Therapy
Arm/Group 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. Naming therapy: 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).
Measure Participants	44
Mean (Standard Error) [units on a scale]	0.80 (0.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral Therapy
	Comments
	Type of Statistical Test	Other
	Comments	This was a single-group study. A t-test was administered comparing pre- and post-treatment CAT modality mean T-scores (range: 30-70, mean: 50; higher scores are better).
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 1 sided
	Comments

Adverse Events

Time Frame	Adverse event data for each participant were collected over the period from baseline (study entry) to the day after completion of intervention (after 4 weeks of behavioral therapy).
Arm/Group Title	Behavioral Therapy
Arm/Group 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. Naming therapy: 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).
All Cause Mortality
	Behavioral Therapy
	Affected / at Risk (%)	# Events
Total	0/46 (0%)
Serious Adverse Events
	Behavioral Therapy
	Affected / at Risk (%)	# Events
Total	0/46 (0%)
Other (Not Including Serious) Adverse Events
	Behavioral Therapy
	Affected / at Risk (%)	# Events
Total	0/46 (0%)

Limitations/Caveats

The full PNT (primary outcome measure) was administered at entry and exit for a subset of the sample (32/44). 12 participants received the full PNT at entry but received abbreviated forms at exit; these forms were found not to be reliable.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.