Dosage and Predictors of Naming Treatment Response in Aphasia - Full Text View

Purpose

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	Intervention	Phase
Aphasia Stroke	Behavioral: Naming therapy	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Dosage and Predictors of Naming Treatment Response in Aphasia

Resource links provided by NLM:

MedlinePlus related topics: Aphasia

U.S. FDA Resources

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:

Philadelphia Naming Test [ Time Frame: This will be administered after completion of intervention, the day after intervention is complete. ] [ Designated as safety issue: No ]
The Philadelphia Naming Test is a performance-based measure commonly used to assess naming (word production) ability among adults with aphasia.

Secondary Outcome Measures:

Comprehensive Aphasia Test [ Time Frame: This will be administered after completion of intervention, the day after intervention is complete. ] [ Designated as safety issue: No ]
The Comprehensive Aphasia Test is a performance-based measure of language processing across multiple language domains commonly used to assess language-processing ability among adults with aphasia.


Estimated Enrollment:	60
Study Start Date:	October 2013
Estimated Study Completion Date:	September 2017
Estimated Primary Completion Date:	September 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: Semantic feature analysis

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.

Eligibility


Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005016

Contacts


Contact: Michael W Dickey, PhD		Michael.Dickey@va.gov

Locations


United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Michael W Dickey, PhD Michael.Dickey@va.gov
Principal Investigator: Michael Walsh Dickey, PhD

Sponsors and Collaborators

VA Office of Research and Development

Investigators


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

More Information

Additional Information:

Click here for more information about this study: Dosage and Predictors of Naming Treatment Response in Aphasia This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site


Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT02005016 History of Changes
Other Study ID Numbers:	O0832-R 1I01RX000832-01A2
Study First Received:	November 14, 2013
Last Updated:	August 9, 2016
Health Authority:	United States: Federal Government
Individual Participant Data
Plan to Share IPD:	No

Keywords provided by VA Office of Research and Development:


Aphasia Language Therapy Acquired Language Disorders Semantics Stroke

Additional relevant MeSH terms:


Aphasia Speech Disorders Language Disorders Communication Disorders	Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2016