AphasiaPhase 2VNeSTNCT01300624
Effect of Verb Network Strengthening Treatment (VNeST) on Lexical Retrieval in Aphasia
A Phase 2 study testing Verb Network Strengthening Treatment in people with Aphasia, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Aphasia
- What is being tested?
- Verb Network Strengthening Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jul 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veterans with a diagnosis of aphasia
- primary language is English
- aphasia due to stroke
Who cannot join
- Functionally bilingual
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
About this study
Official title: Effect Of Verb Network Strengthening Treatment on Lexical Retrieval in Aphasia
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.
Read the 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.
- Conditions
- Aphasia
- Being tested
- Verb Network Strengthening Treatment
- Keywords
- Aphasia, therapy, treatment, verbs, sentences
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verb Network Strengthening TreatmentBehavioural
Also called aphasia treatment, anomia, sentence production, discourse
Treatment to improve word retrieval in sentences and discourse for persons with aphasia due to stroke.
| Study group | Role | What they receive |
|---|---|---|
| Verb Network Strengthening Treatment | Experimental | 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. Receives: Behavioral: Verb Network Strengthening Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trained Sentence Probe
Picture description task that include trained words.
Measured: pre-treatment, post-treatment and 3-months post-treatment (maintenance)
Untrained Sentence Probes
Picture description with sentences containing untrained words.
Measured: 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
Measured: pre-treatment, post-treatment and 3-months post-treatment (maintenance)
Secondary outcomes (4)
Noun Naming
Confrontation naming of 162 objects
Measured: pre-treatment and post-treatment
Verb Naming
Confrontation of 100 action pictures
Measured: pre-treatment and post-treatment
Western Aphasia Battery
Standardized measure of aphasia severity
Measured: 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.
Measured: pre-treatment, post-treatment and 3-months post-treatment (maintenance)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lisa A. Edmonds, PhD, Principal investigator, North Florida/South Georgia Veterans Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300624
- Sponsor's protocol ID
- C7695-R
- Acronym
- VNeST
- Status last verified
- Jun 2015
- First submitted
- 21 Jan 2011
- Last updated
- 9 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Verb Network Strengthening Treatment on Lexical Retrieval in Aphasia
- ClinicalTrials.gov ID
- NCT01300624
- Acronym / sponsor ID
- VNeST / C7695-R
- Conditions
- Aphasia
- Keywords
- Aphasia, therapy, treatment, verbs, sentences
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Mar 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 Feb 2011 (estimated)
- Results
- Posted 9 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Verb Network Strengthening Treatment | Experimental | Behavioral: Verb Network Strengthening TreatmentVerb 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veterans with a diagnosis of aphasia
- primary language is English
- aphasia due to stroke
Key exclusion criteria (1 listed)
- Functionally bilingual
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verb Network Strengthening TreatmentAlso: aphasia treatment, anomia, sentence production, discourseTreatment to improve word retrieval in sentences and discourse for persons with aphasia due to stroke. | Behavioural | Verb Network Strengthening Treatment |
Primary outcome
Trained Sentence Probe
Time frame: pre-treatment, post-treatment and 3-months post-treatment (maintenance)
Picture description task that include trained words.
Untrained Sentence Probes
Time frame: pre-treatment, post-treatment and 3-months post-treatment (maintenance)
Picture description with sentences containing untrained words.
Complete Utterances in Discourse
Time frame: pre-treatment, post-treatment and 3-months post-treatment (maintenance)
Sentence in discourse that were relevant to topic and syntactically correct
4 secondary outcomes
Noun Naming
Time frame: pre-treatment and post-treatment
Verb Naming
Time frame: pre-treatment and post-treatment
Western Aphasia Battery
Time frame: pre-treatment and post-treatment
Communicative Effectiveness Ratings
Time frame: pre-treatment, post-treatment and 3-months post-treatment (maintenance)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa A. Edmonds, PhD principal investigator
North Florida/South Georgia Veterans Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Verb Network Strengthening Treatment in people with Aphasia, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trained Sentence Probe (time frame: pre-treatment, post-treatment and 3-months post-treatment (maintenance)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.