N/A
Completed N=46
Dosage and Predictors of Naming Treatment Response in Aphasia
Source: ClinicalTrials.gov NCT02005016 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Change From Baseline in Philadelphia Naming Test Score — 5.91 score on a scale — p=<0.005
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Philadelphia Naming Test Score |
5.91 | <0.005 sig |
| SECONDARY Change From Baseline on Comprehensive Aphasia Test Modality Mean T-Score |
0.80 | <0.001 sig |
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
Data sourced from ClinicalTrials.gov (NCT02005016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.