Dosage and Predictors of Naming Treatment Response in Aphasia

NCT02005016 | Completed Results

• 2 other identifiers: O0832-R1I01RX000832-01A2
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia; Stroke

Keywords

Aphasia; Language Therapy; Acquired Language Disorders; Semantics; Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (at study entry) to the day after completion of intervention (after 4 weeks of behavioral therapy).

Secondary Outcomes (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).

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Naming therapy BEHAVIORAL

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).

Also known as: Semantic feature analysis

Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Links

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

MeSH Terms

Conditions

Aphasia; Stroke; Language Disorders

Condition Hierarchy (Ancestors)

Speech Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and 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.

Results Point of Contact

• Title: Dr. Michael Dickey
• Organization: VA Pittsburgh Healthcare System

michael.dickey@va.gov

412-360-6467

Study Officials

• Michael W Dickey, PhD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: December 9, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: September 30, 2018
• Last Updated: November 4, 2019
• Results First Posted: November 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)