A Phase 2 interventional study of Verb Network Strengthening Treatment in Aphasia, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-09.
Sponsored by US Department of Veterans Affairs · Phase 2, Interventional, and Treatment
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.
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.
365 studies on the registry are indexed under Aphasia; 89 are open to participants now.
This study's enrollment of 11 is below the median of 30 across 316 interventional studies indexed under Aphasia.
Browse Aphasia studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Verb Network Strengthening Treatment
Treatment to improve word retrieval in sentences and discourse for persons with aphasia due to stroke.
Also known as: aphasia treatment, anomia, sentence production, discourse
Trained Sentence Probe
Picture description task that include trained words.
Time frame: pre-treatment, post-treatment and 3-months post-treatment (maintenance)
Untrained Sentence Probes
Picture description with sentences containing untrained words.
Time frame: pre-treatment, post-treatment and 3-months post-treatment (maintenance)
Complete Utterances in Discourse
Sentence in discourse that were relevant to topic and syntactically correct
Time frame: pre-treatment, post-treatment and 3-months post-treatment (maintenance)
Noun Naming
Confrontation naming of 162 objects
Time frame: pre-treatment and post-treatment
Verb Naming
Confrontation of 100 action pictures
Time frame: pre-treatment and post-treatment
Western Aphasia Battery
Standardized measure of aphasia severity
Time frame: pre-treatment and post-treatment
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.
Time frame: pre-treatment, post-treatment and 3-months post-treatment (maintenance)
| Milestone | Verb Network Strengthening Treatment |
|---|---|
| Started | 11 |
| Completed | 11 |
| Not completed | 0 |
Picture description task that include trained words.
| percentage of correct sentences | Verb Network Strengthening Treatment |
|---|---|
| Pre-treatment | 20.4 ± 13.3 |
| Post-treatment | 58.8 ± 33.9 |
| 3 months post-treatment (maintenance) | 56.0 ± 29.9 |
Picture description with sentences containing untrained words.
| percentage of correct sentences | Verb Network Strengthening Treatment |
|---|---|
| Pre-treatment | 19.8 ± 11.0 |
| Post-treatment | 40.9 ± 24.9 |
| 3 months post-treatment (maintenance) | 43.0 ± 27.5 |
Confrontation naming of 162 objects
| percentage of correct naming | Verb Network Strengthening Treatment |
|---|---|
| Pre-treatment | 79.9 ± 12.3 |
| Post-treatment | 85.1 ± 12.6 |
Confrontation of 100 action pictures
| percentage of correct naming | Verb Network Strengthening Treatment |
|---|---|
| Pre-treatment | 64.6 ± 18.2 |
| Post-treatment | 74.2 ± 16.0 |
Sentence in discourse that were relevant to topic and syntactically correct
| percentage of complete utterances | Verb Network Strengthening Treatment |
|---|---|
| Pre-treatment | 39.7 ± 11.9 |
| Post-treatment | 46.7 ± 16.0 |
| 3 months post-treatment (maintenance) | 47.9 ± 13.8 |
Standardized measure of aphasia severity
| units on a scale | Verb Network Strengthening Treatment |
|---|---|
| Pre-treatment | 75.9 ± 10.4 |
| Post-treatment | 82.1 ± 8.6 |
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.
| units on a scale | Verb Network Strengthening Treatment |
|---|---|
| Pre-treatment | 32.6 ± 9.7 |
| Post-treatment | 65.3 ± 11.2 |
| 3 months post-treatment (maintenance) | 58.3 ± 15.6 |
Collected over 3 years, 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Verb Network Strengthening Treatment | — | 0/11 (0%) | 0/11 (0%) |
Number of participants was based on pilot study results and consistent with the relevant literature.
| Age, Continuous(years) | Verb Network Strengthening Treatment |
|---|---|
| Mean | 63.9 ± 12.4 |
| Sex: Female, Male(Participants) | Verb Network Strengthening Treatment |
|---|---|
| Female | 4 |
| Male | 7 |
| Region of Enrollment(participants) | Verb Network Strengthening Treatment |
|---|---|
| United States | 11 |
| Noun naming(Percentage of correct naming) | Verb Network Strengthening Treatment |
|---|---|
| Mean | 79.9 ± 12.3 |
| Verb naming(Percentage of correct naming) | Verb Network Strengthening Treatment |
|---|---|
| Mean | 64.6 ± 18.2 |
| Trained sentence probes(Percentage correct sentence production) | Verb Network Strengthening Treatment |
|---|---|
| Mean | 20.4 ± 13.3 |
| Untrained sentence probe(Percentage correct sentence production) | Verb Network Strengthening Treatment |
|---|---|
| Mean | 19.8 ± 11.0 |
| Complete Utterances in discourse(Percentage of complete utterances) | Verb Network Strengthening Treatment |
|---|---|
| Mean | 39.7 ± 1.9 |
2 further baseline measures are reported on the registry.
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs