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

Aphasia Clinical Trial

— VNeST  

Official title:

Effect Of Verb Network Strengthening Treatment on Lexical Retrieval in Aphasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300624
• Other study ID #: C7695-R
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2011
• Last updated: June 5, 2015
• Start date: March 2011
• Est. completion date: July 2014

Study information

• Verified date: June 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Veterans with a diagnosis of aphasia

• primary language is English

• aphasia due to stroke

Exclusion Criteria:

• Functionally bilingual

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphasia

Intervention

Behavioral:
• Verb Network Strengthening Treatment
Treatment to improve word retrieval in sentences and discourse for persons with aphasia due to stroke.

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trained Sentence Probe	Picture description task that include trained words.	pre-treatment, post-treatment and 3-months post-treatment (maintenance)	No
Primary	Untrained Sentence Probes	Picture description with sentences containing untrained words.	pre-treatment, post-treatment and 3-months post-treatment (maintenance)	No
Primary	Complete Utterances in Discourse	Sentence in discourse that were relevant to topic and syntactically correct	pre-treatment, post-treatment and 3-months post-treatment (maintenance)	No
Secondary	Noun Naming	Confrontation naming of 162 objects	pre-treatment and post-treatment	No
Secondary	Verb Naming	Confrontation of 100 action pictures	pre-treatment and post-treatment	No
Secondary	Western Aphasia Battery	Standardized measure of aphasia severity	pre-treatment and post-treatment	No
Secondary	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.	pre-treatment, post-treatment and 3-months post-treatment (maintenance)	No