- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01300624
Effect of Verb Network Strengthening Treatment (VNeST) on Lexical Retrieval in Aphasia (VNeST)
Effect Of Verb Network Strengthening Treatment on Lexical Retrieval in Aphasia
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Florida
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Gainesville, Florida, United States, 32608
- North Florida/South Georgia Veterans Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Veterans with a diagnosis of aphasia
- primary language is English
- aphasia due to stroke
Exclusion Criteria:
- Functionally bilingual
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Verb Network Strengthening Treatment
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.
|
Treatment to improve word retrieval in sentences and discourse for persons with aphasia due to stroke.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trained Sentence Probe
Time Frame: pre-treatment, post-treatment and 3-months post-treatment (maintenance)
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Picture description task that include trained words.
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pre-treatment, post-treatment and 3-months post-treatment (maintenance)
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Untrained Sentence Probes
Time Frame: pre-treatment, post-treatment and 3-months post-treatment (maintenance)
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Picture description with sentences containing untrained words.
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pre-treatment, post-treatment and 3-months post-treatment (maintenance)
|
Complete Utterances in Discourse
Time Frame: pre-treatment, post-treatment and 3-months post-treatment (maintenance)
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Sentence in discourse that were relevant to topic and syntactically correct
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pre-treatment, post-treatment and 3-months post-treatment (maintenance)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Noun Naming
Time Frame: pre-treatment and post-treatment
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Confrontation naming of 162 objects
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pre-treatment and post-treatment
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Verb Naming
Time Frame: pre-treatment and post-treatment
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Confrontation of 100 action pictures
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pre-treatment and post-treatment
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Western Aphasia Battery
Time Frame: pre-treatment and post-treatment
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Standardized measure of aphasia severity
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pre-treatment and post-treatment
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Communicative Effectiveness Ratings
Time Frame: pre-treatment, post-treatment and 3-months post-treatment (maintenance)
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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.
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pre-treatment, post-treatment and 3-months post-treatment (maintenance)
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Collaborators and Investigators
Investigators
- Principal Investigator: Lisa A. Edmonds, PhD, North Florida/South Georgia Veterans Health System
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C7695-R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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