Semantic Feature Analysis Treatment for Aphasia

• ClinicalTrials.gov Identifier: NCT04215952
• Recruitment Status: Recruiting
• First Posted: January 2, 2020
• Last Update Posted: January 18, 2022
• Sponsor: VA Pittsburgh Healthcare System
• Collaborator: Penn State University
• Information provided by (Responsible Party): VA Pittsburgh Healthcare System

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.

Condition or disease	Intervention/treatment	Phase
Aphasia	Behavioral: Semantic Feature Analysis Treatment	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Study participants will be randomly assigned to one of two treatment conditions.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
• Primary Purpose: Treatment
• Official Title: Optimizing and Understanding Semantic Feature Analysis Treatment for Aphasia: A Randomized Controlled Comparative Effectiveness Trial
• Actual Study Start Date: February 24, 2020
• Estimated Primary Completion Date: April 30, 2024
• Estimated Study Completion Date: August 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: SFA Experimental Intervention; A modified version of Semantic Feature Analysis will be administered.	Behavioral: Semantic Feature Analysis Treatment; 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.; Other Name: Semantically Oriented Naming Treatment
Active Comparator: SFA Active Comparator Intervention; A standard version of Semantic Feature Analysis will be administered.	Behavioral: Semantic Feature Analysis Treatment; 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.; Other Name: Semantically Oriented Naming Treatment

Outcome Measures

Primary Outcome Measures :

1. Confrontation Naming [ 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 ]
   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 :

1. Nicholas and Brookshire Picture Descriptions [ 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 ]
   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).
2. Aphasia Communication Outcome Measure (ACOM) [ 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 ]
   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.
3. Visual World Paradigm [ 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 ]
   Change in the mean proportions of fixations to the target and to the related competitor (compared to unrelated distractor images), averaged across trials.
4. Functional MRI [ 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 ]
   Changes in task-related blood oxygen level dependent (BOLD) activation, and task-related and resting state functional connectivity
5. Comprehensive Aphasia Test [ 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 ]
   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.
6. Philadelphia Naming Test (PNT) [ 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 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Mary Sullivan, B.S.; 412-360-6472; mary.sullivan@va.gov

Contact: Alyssa Autenreith, M.A.; 412-360-6495; alyssa.autenreith@va.gov

Locations

United States, Pennsylvania

VA Pittsburgh Healthcare System; Recruiting

Pittsburgh, Pennsylvania, United States, 15240

Sponsors and Collaborators

VA Pittsburgh Healthcare System

Penn State University

Investigators

• Principal Investigator: William D Hula, Ph.D.; VA Pittsburgh Healthcare System
• Principal Investigator: Patrick J Doyle, Ph.D.; VA Pittsburgh Healthcare System

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: VA Pittsburgh Healthcare System
• ClinicalTrials.gov Identifier: NCT04215952
• Other Study ID Numbers: PRO00003086
• First Posted: January 2, 2020
• Last Update Posted: January 18, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by VA Pittsburgh Healthcare System:

Anomia; Semantic Feature Analysis

Additional relevant MeSH terms:

Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases