NCT04215952

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 24, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

5.5 years

First QC Date

December 20, 2019

Last Update Submit

June 25, 2025

Conditions

Keywords

AnomiaSemantic Feature Analysis

Outcome Measures

Primary Outcomes (1)

  • Confrontation Naming

    Change in naming accuracy on 30 treated pictured object nouns and 30 untreated pictured object nouns semantically related to the treated items.

    (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 Outcomes (6)

  • Nicholas and Brookshire Picture Descriptions

    (1) 1 week prior to intervention; (2) immediately prior to intervention; (3) 1-2 days post intervention (4) 8 to 12 weeks post intervention

  • Aphasia Communication Outcome Measure (ACOM)

    (1) 1 week prior to intervention; (2) immediately prior to intervention; (3) 1-2 days post intervention (4) 8 to 12 weeks post intervention

  • Visual World Paradigm

    (1) 1 week prior to intervention; (2) immediately prior to intervention; (3) 1-2 days post intervention (4) 8 to 12 weeks post intervention

  • Functional MRI

    (1) 1 week prior to intervention; (2) immediately prior to intervention; (3) 1-2 days post intervention (4) 8 to 12 weeks post intervention

  • Comprehensive Aphasia Test

    (1) 1 week prior to intervention; (2) immediately prior to intervention; (3) 1-2 days post intervention (4) 8 to 12 weeks post intervention

  • +1 more secondary outcomes

Study Arms (2)

SFA Experimental Intervention

EXPERIMENTAL

A modified version of Semantic Feature Analysis will be administered.

Behavioral: Semantic Feature Analysis Treatment

SFA Active Comparator Intervention

ACTIVE COMPARATOR

A standard version of Semantic Feature Analysis will be administered.

Behavioral: Semantic Feature Analysis Treatment

Interventions

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.

Also known as: Semantically Oriented Naming Treatment
SFA Active Comparator InterventionSFA Experimental Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Right Hemisphere stroke
  • Neurological disease other than stroke
  • Significant psychiatric disorder
  • Severe motor speech disorder
  • Active substance dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (4)

  • 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.

    PMID: 8487525BACKGROUND
  • 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.

    PMID: 8028321BACKGROUND
  • 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.

    PMID: 25813461BACKGROUND
  • 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.

    PMID: 25812178BACKGROUND

MeSH Terms

Conditions

AphasiaAnomia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William D Hula, Ph.D.

    VA Pittsburgh Healthcare System

    PRINCIPAL INVESTIGATOR
  • Patrick J Doyle, Ph.D.

    VA Pittsburgh Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study participants will be randomly assigned to one of two treatment conditions.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2019

First Posted

January 2, 2020

Study Start

February 24, 2020

Primary Completion

August 30, 2025

Study Completion

August 30, 2025

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations