Semantic Feature Analysis Treatment for Aphasia
Primary Purpose
Aphasia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Semantic Feature Analysis Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring Anomia, Semantic Feature Analysis
Eligibility Criteria
Inclusion Criteria:
- 6 months post-onset of aphasia due to unilateral left-hemisphere (LH) stroke
- Independent in activities of daily living (ADLs) necessary to live in community-based housing or available caregiver to assist with ADLs
- Medically stable and able to tolerate intensive treatment schedule (e.g. no uncontrolled seizures, difficulty breathing, frequent migraines)
- English as a first language
- No participation in any other speech-language treatment during this study, including follow-up period
- Sufficient auditory comprehension abilities demonstrated during screening
- Sufficient naming impairment exhibited during screening
Exclusion Criteria:
- Right Hemisphere stroke
- Neurological disease other than stroke
- Significant psychiatric disorder
- Severe motor speech disorder
- Active substance dependence
Sites / Locations
- VA Pittsburgh Healthcare SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SFA Experimental Intervention
SFA Active Comparator Intervention
Arm Description
A modified version of Semantic Feature Analysis will be administered.
A standard version of Semantic Feature Analysis will be administered.
Outcomes
Primary Outcome Measures
Confrontation Naming
Change in naming accuracy on 30 treated pictured object nouns and 30 untreated pictured object nouns semantically related to the treated items.
Secondary Outcome Measures
Nicholas and Brookshire Picture Descriptions
Change in the number of correct information units produced during connected speech in response to the stimuli and procedures described by Nicholas and Brookshire (1993) and Brookshire & Nicholas (1994).
Aphasia Communication Outcome Measure (ACOM)
Change in ACOM T-scores derived from the scoring model described by Hula and colleagues (2015). Higher scores on this scale indicate better self-reported communicative functioning. The scale was constructed such that the average score is 50 and the standard deviation is 10 points. The minimum possible score is 15 and the maximum possible score is 85.
Visual World Paradigm
Change in the mean proportions of fixations to the target and to the related competitor (compared to unrelated distractor images), averaged across trials.
Functional MRI
Changes in task-related blood oxygen level dependent (BOLD) activation, and task-related and resting state functional connectivity
Comprehensive Aphasia Test
Change in the Modality Mean T-Score computed from the following six modality subtests: Spoken Language Comprehension, Written Language Comprehension, Repetition, Naming, Reading, and Writing.
Philadelphia Naming Test (PNT)
Change in PNT score estimates derived from the item response theory model described by Fergadiotis, Kellough, & Hula (2015). Scores will be scaled such that the expected average score among persons with aphasia is 50 and the standard deviation is 10, with minimum and maximum possible scores of approximately 20 and 80, respectively. Higher scores indicate better outcomes.
Full Information
NCT ID
NCT04215952
First Posted
December 20, 2019
Last Updated
January 14, 2022
Sponsor
VA Pittsburgh Healthcare System
Collaborators
Penn State University
1. Study Identification
Unique Protocol Identification Number
NCT04215952
Brief Title
Semantic Feature Analysis Treatment for Aphasia
Official Title
Optimizing and Understanding Semantic Feature Analysis Treatment for Aphasia: A Randomized Controlled Comparative Effectiveness Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Pittsburgh Healthcare System
Collaborators
Penn State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This randomized controlled comparative effectiveness study examines manipulation of a key component of an established and efficacious treatment for naming impairments in aphasia, along with cognitive and brain correlates of treatment success. Study participants will be randomly assigned to one of two treatment conditions comparing two different versions of Semantic Feature Analysis treatment. Their performance on standardized and study-specific measures will be used to determine which version of the treatment provides superior outcomes, and measures of automatic language processing and functional brain imaging will also be used to identify the underlying neurocognitive mechanisms associated with positive treatment response.
Detailed Description
This randomized comparative effectiveness trial examines whether active manipulation of a key component of semantic feature analysis (SFA) treatment for word-finding difficulty in aphasia improves outcomes. 40 study participants will be recruited and randomized to receive one of the two versions of the treatment. The total treatment time will be equated in the two conditions.
Study participants will be housed locally at the Pittsburgh site at no cost and will be eligible to receive reimbursement for travel expenses. During the five-week treatment phase of the study, participants will receive 60 hours of SFA treatment with pre- and post-treatment assessment of their ability to name pictures of treated and untreated, semantically related nouns. Other secondary outcomes, including measures of connected speech and patient-reported communication ability will also be collected. In order to address unresolved questions about the underlying cognitive and neural mechanisms of SFA, participants will also receive concurrent pre- and post-treatment assessment of automatic word processing ability using eye-tracking methods and functional magnetic resonance imaging (fMRI). Participants will also be asked to return to Pittsburgh for two days approximately 2-3 months later for follow-up language, eye-tracking, and fMRI testing.
The language testing results will be used to determine which version of SFA treatment optimizes outcomes. The eye-tracking results will be used to infer whether SFA's positive effects can be attributed to improved activation of lexical-semantic representations, improved ability to inhibit competing representations, or both. The fMRI results will be used to identify the brain networks and activation changes associated with changes in naming ability resulting from SFA. This study will provide theoretically and clinically relevant information about how aphasia treatment should be delivered and the neurocognitive mechanisms underlying its effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
Anomia, Semantic Feature Analysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study participants will be randomly assigned to one of two treatment conditions.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Administration and scoring of all primary and secondary outcome measures will be carried out by a speech pathologist on study staff who (1) is not the treating clinician for the participant being assessed, and (2) is blind to the group assignment of the participant being assessed. Because SFA is a behavioral intervention, it will not be possible to blind the treating clinician to group assignment. It will also be impossible to definitively blind participants to their group assignment. However, we will not formally disclose to participants the group to which they have been assigned, and in the informed consent process, we will describe the conditions only in relative terms.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SFA Experimental Intervention
Arm Type
Experimental
Arm Description
A modified version of Semantic Feature Analysis will be administered.
Arm Title
SFA Active Comparator Intervention
Arm Type
Active Comparator
Arm Description
A standard version of Semantic Feature Analysis will be administered.
Intervention Type
Behavioral
Intervention Name(s)
Semantic Feature Analysis Treatment
Other Intervention Name(s)
Semantically Oriented Naming Treatment
Intervention Description
On each treatment trial, the clinician will show the participant with aphasia a pictured object and ask them to name it. The clinician will then guide the participant in verbally generating semantic features for the target, using a chart that specifies five kinds of features: group, use/action, properties, location, and personal associations. When the participant cannot generate a given feature, cueing or other assistance will be provided. After feature generation, the clinician will ask the participant to name the picture again and provide cueing if needed. The clinician will then review the generated features and ask the participant to name the item once more, with cueing if needed. Finally, the clinician will ask the participant to say a sentence containing the target word and provide cueing if needed. Treatment will then proceed to the next item. Participants will receive approximately 20 hours of treatment on each of three 10-item lists, for a total of 60 hours of treatment.
Primary Outcome Measure Information:
Title
Confrontation Naming
Description
Change in naming accuracy on 30 treated pictured object nouns and 30 untreated pictured object nouns semantically related to the treated items.
Time Frame
(1) 1 week prior to intervention; (2) immediately prior to intervention; (3) 1-2 days post intervention (4) 8 to 12 weeks post intervention
Secondary Outcome Measure Information:
Title
Nicholas and Brookshire Picture Descriptions
Description
Change in the number of correct information units produced during connected speech in response to the stimuli and procedures described by Nicholas and Brookshire (1993) and Brookshire & Nicholas (1994).
Time Frame
(1) 1 week prior to intervention; (2) immediately prior to intervention; (3) 1-2 days post intervention (4) 8 to 12 weeks post intervention
Title
Aphasia Communication Outcome Measure (ACOM)
Description
Change in ACOM T-scores derived from the scoring model described by Hula and colleagues (2015). Higher scores on this scale indicate better self-reported communicative functioning. The scale was constructed such that the average score is 50 and the standard deviation is 10 points. The minimum possible score is 15 and the maximum possible score is 85.
Time Frame
(1) 1 week prior to intervention; (2) immediately prior to intervention; (3) 1-2 days post intervention (4) 8 to 12 weeks post intervention
Title
Visual World Paradigm
Description
Change in the mean proportions of fixations to the target and to the related competitor (compared to unrelated distractor images), averaged across trials.
Time Frame
(1) 1 week prior to intervention; (2) immediately prior to intervention; (3) 1-2 days post intervention (4) 8 to 12 weeks post intervention
Title
Functional MRI
Description
Changes in task-related blood oxygen level dependent (BOLD) activation, and task-related and resting state functional connectivity
Time Frame
(1) 1 week prior to intervention; (2) immediately prior to intervention; (3) 1-2 days post intervention (4) 8 to 12 weeks post intervention
Title
Comprehensive Aphasia Test
Description
Change in the Modality Mean T-Score computed from the following six modality subtests: Spoken Language Comprehension, Written Language Comprehension, Repetition, Naming, Reading, and Writing.
Time Frame
(1) 1 week prior to intervention; (2) immediately prior to intervention; (3) 1-2 days post intervention (4) 8 to 12 weeks post intervention
Title
Philadelphia Naming Test (PNT)
Description
Change in PNT score estimates derived from the item response theory model described by Fergadiotis, Kellough, & Hula (2015). Scores will be scaled such that the expected average score among persons with aphasia is 50 and the standard deviation is 10, with minimum and maximum possible scores of approximately 20 and 80, respectively. Higher scores indicate better outcomes.
Time Frame
(1) 1 week prior to intervention; (2) immediately prior to intervention; (3) 1-2 days post intervention (4) 8 to 12 weeks post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
6 months post-onset of aphasia due to unilateral left-hemisphere (LH) stroke
Independent in activities of daily living (ADLs) necessary to live in community-based housing or available caregiver to assist with ADLs
Medically stable and able to tolerate intensive treatment schedule (e.g. no uncontrolled seizures, difficulty breathing, frequent migraines)
English as a first language
No participation in any other speech-language treatment during this study, including follow-up period
Sufficient auditory comprehension abilities demonstrated during screening
Sufficient naming impairment exhibited during screening
Exclusion Criteria:
Right Hemisphere stroke
Neurological disease other than stroke
Significant psychiatric disorder
Severe motor speech disorder
Active substance dependence
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Sullivan, B.S.
Phone
412-360-6472
Email
mary.sullivan@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Alyssa Autenreith, M.A.
Phone
412-360-6495
Email
alyssa.autenreith@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William D Hula, Ph.D.
Organizational Affiliation
VA Pittsburgh Healthcare System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick J Doyle, Ph.D.
Organizational Affiliation
VA Pittsburgh Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8487525
Citation
Nicholas LE, Brookshire RH. A system for quantifying the informativeness and efficiency of the connected speech of adults with aphasia. J Speech Hear Res. 1993 Apr;36(2):338-50. doi: 10.1044/jshr.3602.338.
Results Reference
background
PubMed Identifier
8028321
Citation
Brookshire RH, Nicholas LE. Speech sample size and test-retest stability of connected speech measures for adults with aphasia. J Speech Hear Res. 1994 Apr;37(2):399-407. doi: 10.1044/jshr.3702.399.
Results Reference
background
PubMed Identifier
25813461
Citation
Fergadiotis G, Kellough S, Hula WD. Item Response Theory Modeling of the Philadelphia Naming Test. J Speech Lang Hear Res. 2015 Jun 1;58(3):865-877. doi: 10.1044/2015_JSLHR-L-14-0249.
Results Reference
background
PubMed Identifier
25812178
Citation
Hula WD, Doyle PJ, Stone CA, Austermann Hula SN, Kellough S, Wambaugh JL, Ross KB, Schumacher JG, St Jacque A. The Aphasia Communication Outcome Measure (ACOM): Dimensionality, Item Bank Calibration, and Initial Validation. J Speech Lang Hear Res. 2015 Jun;58(3):906-19. doi: 10.1044/2015_JSLHR-L-14-0235.
Results Reference
background
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Semantic Feature Analysis Treatment for Aphasia
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