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Effect of Verb Network Strengthening Treatment (VNeST) on Lexical Retrieval in Aphasia (VNeST)

Primary Purpose

Aphasia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Verb Network Strengthening Treatment
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Aphasia, therapy, treatment, verbs, sentences

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Veterans with a diagnosis of aphasia
  • primary language is English
  • aphasia due to stroke

Exclusion Criteria:

  • Functionally bilingual

Sites / Locations

  • North Florida/South Georgia Veterans Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Verb Network Strengthening Treatment

Arm Description

Verb Network Strengthening Treatment (VNeST) tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced.

Outcomes

Primary Outcome Measures

Trained Sentence Probe
Picture description task that include trained words.
Untrained Sentence Probes
Picture description with sentences containing untrained words.
Complete Utterances in Discourse
Sentence in discourse that were relevant to topic and syntactically correct

Secondary Outcome Measures

Noun Naming
Confrontation naming of 162 objects
Verb Naming
Confrontation of 100 action pictures
Western Aphasia Battery
Standardized measure of aphasia severity
Communicative Effectiveness Ratings
This questionnaire (Lomas et al, 1989) was provided to persons who communicated with the treatment participant regularly (e.g., a spouse). They rated how well the participant was able to perform on 16 common communication tasks (e.g., participating in a conversation over coffee). They rated each scenario along a line that spanned between the two extremes of ability, from "not at all able" to "as able as before the stroke." The line was 100 mm. To score responses, the place where they bisected the line was measured. An average of their responses across the 16 questions was calculated.

Full Information

First Posted
January 21, 2011
Last Updated
June 5, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT01300624
Brief Title
Effect of Verb Network Strengthening Treatment (VNeST) on Lexical Retrieval in Aphasia
Acronym
VNeST
Official Title
Effect Of Verb Network Strengthening Treatment on Lexical Retrieval in Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of Verb Network Strengthening Treatment (VNeST) on the ability to produce sentences and connected speech in persons with aphasia.
Detailed Description
Stroke is the leading cause of disability in the United States today, and aphasia, a language disorder that affects production and comprehension of language, remains one of the most devastating aspects of stroke recovery. The most prominent symptom of aphasia is difficulty retrieving words, especially in sentence production and connected speech (e.g., telling a story, having a conversation). The current project examines the effect Verb Network Strengthening Treatment (VNeST), a language therapy, on the ability of persons with moderate aphasia to retrieve words in sentences and connected speech. The primary goals of VNeST are to 1) increase the specificity of nouns and verbs in sentences, 2) maximize improvement to untrained words across a variety of language tasks, and 3) engage and challenge participants with salient and relevant treatment materials and activities. Persons with aphasia who are enrolled in the study will receive VNeST for 10 weeks for 4 hours per week. Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say "to get the right length of board," (why) "at a construction site," (where) and "when building a house" (where)). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced. Prior to treatment, testing will be conducted on participants to establish their abilities to retrieve words in the following contexts: 1) naming pictures of objects and actions, 2) sentences, and 3) connected speech. Participants and a family member or friend (i.e., proxy) will also complete a questionnaire about how the participant is able to communicate in everyday tasks (e.g., indicating yes or no, providing medical information). During the treatment phase, sentence production abilities on items related to treatment will be examined in order to determine how word retrieval abilities are changing with treatment. After the completion of treatment, all measures examined prior to treatment (including the questionnaire) will be re-examined in order to determine whether improvement was observed. Additionally, participants will complete testing one more time 3 months after the completion of treatment to determine if post-treatment improvements were maintained. Finally, an analysis of improvement over time across the treatment phase will be examined in order to determine the rate of improvement (or lack of it) over time. All statistical analyses will use group data (i.e., group design), but additional examination of improvements for each participant (i.e., single subject design) will also be conducted. Thus, the overall experimental design is a mix of group and single subject analyses. The findings from this study will help to inform aphasia treatment practices and potentially allow for a larger study with more participants in a clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
Aphasia, therapy, treatment, verbs, sentences

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verb Network Strengthening Treatment
Arm Type
Experimental
Arm Description
Verb Network Strengthening Treatment (VNeST) tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced.
Intervention Type
Behavioral
Intervention Name(s)
Verb Network Strengthening Treatment
Other Intervention Name(s)
aphasia treatment, anomia, sentence production, discourse
Intervention Description
Treatment to improve word retrieval in sentences and discourse for persons with aphasia due to stroke.
Primary Outcome Measure Information:
Title
Trained Sentence Probe
Description
Picture description task that include trained words.
Time Frame
pre-treatment, post-treatment and 3-months post-treatment (maintenance)
Title
Untrained Sentence Probes
Description
Picture description with sentences containing untrained words.
Time Frame
pre-treatment, post-treatment and 3-months post-treatment (maintenance)
Title
Complete Utterances in Discourse
Description
Sentence in discourse that were relevant to topic and syntactically correct
Time Frame
pre-treatment, post-treatment and 3-months post-treatment (maintenance)
Secondary Outcome Measure Information:
Title
Noun Naming
Description
Confrontation naming of 162 objects
Time Frame
pre-treatment and post-treatment
Title
Verb Naming
Description
Confrontation of 100 action pictures
Time Frame
pre-treatment and post-treatment
Title
Western Aphasia Battery
Description
Standardized measure of aphasia severity
Time Frame
pre-treatment and post-treatment
Title
Communicative Effectiveness Ratings
Description
This questionnaire (Lomas et al, 1989) was provided to persons who communicated with the treatment participant regularly (e.g., a spouse). They rated how well the participant was able to perform on 16 common communication tasks (e.g., participating in a conversation over coffee). They rated each scenario along a line that spanned between the two extremes of ability, from "not at all able" to "as able as before the stroke." The line was 100 mm. To score responses, the place where they bisected the line was measured. An average of their responses across the 16 questions was calculated.
Time Frame
pre-treatment, post-treatment and 3-months post-treatment (maintenance)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Veterans with a diagnosis of aphasia primary language is English aphasia due to stroke Exclusion Criteria: Functionally bilingual
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa A. Edmonds, PhD
Organizational Affiliation
North Florida/South Georgia Veterans Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

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Effect of Verb Network Strengthening Treatment (VNeST) on Lexical Retrieval in Aphasia

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