Trial Outcomes & Findings for Effect of Verb Network Strengthening Treatment (VNeST) on Lexical Retrieval in Aphasia (NCT NCT01300624)

NCT ID: NCT01300624

Last Updated: 2015-06-09

Results Overview

Picture description task that include trained words.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

pre-treatment, post-treatment and 3-months post-treatment (maintenance)

Results posted on

2015-06-09

Participant Flow

Participant milestones

Participant milestones
Measure
Verb Network Strengthening Treatment
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.
Overall Study
STARTED
11
Overall Study
COMPLETED
11
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Verb Network Strengthening Treatment
n=11 Participants
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.
Age, Continuous
63.9 years
STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
Region of Enrollment
United States
11 participants
n=5 Participants
Noun naming
79.9 Percentage of correct naming
STANDARD_DEVIATION 12.3 • n=5 Participants
Verb naming
64.6 Percentage of correct naming
STANDARD_DEVIATION 18.2 • n=5 Participants
Trained sentence probes
20.4 Percentage correct sentence production
STANDARD_DEVIATION 13.3 • n=5 Participants
Untrained sentence probe
19.8 Percentage correct sentence production
STANDARD_DEVIATION 11.0 • n=5 Participants
Complete Utterances in discourse
39.7 Percentage of complete utterances
STANDARD_DEVIATION 1.9 • n=5 Participants
Western Aphasia Battery
75.9 units on a scale
STANDARD_DEVIATION 10.4 • n=5 Participants
Communicative Effectiveness Ratings
32.6 units on a scale
STANDARD_DEVIATION 65.3 • n=5 Participants

PRIMARY outcome

Timeframe: pre-treatment, post-treatment and 3-months post-treatment (maintenance)

Picture description task that include trained words.

Outcome measures

Outcome measures
Measure
Verb Network Strengthening Treatment
n=11 Participants
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.
Trained Sentence Probe
Pre-treatment
20.4 percentage of correct sentences
Standard Deviation 13.3
Trained Sentence Probe
Post-treatment
58.8 percentage of correct sentences
Standard Deviation 33.9
Trained Sentence Probe
3 months post-treatment (maintenance)
56.0 percentage of correct sentences
Standard Deviation 29.9

PRIMARY outcome

Timeframe: pre-treatment, post-treatment and 3-months post-treatment (maintenance)

Picture description with sentences containing untrained words.

Outcome measures

Outcome measures
Measure
Verb Network Strengthening Treatment
n=11 Participants
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.
Untrained Sentence Probes
Pre-treatment
19.8 percentage of correct sentences
Standard Deviation 11.0
Untrained Sentence Probes
Post-treatment
40.9 percentage of correct sentences
Standard Deviation 24.9
Untrained Sentence Probes
3 months post-treatment (maintenance)
43.0 percentage of correct sentences
Standard Deviation 27.5

PRIMARY outcome

Timeframe: pre-treatment, post-treatment and 3-months post-treatment (maintenance)

Sentence in discourse that were relevant to topic and syntactically correct

Outcome measures

Outcome measures
Measure
Verb Network Strengthening Treatment
n=11 Participants
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.
Complete Utterances in Discourse
Pre-treatment
39.7 percentage of complete utterances
Standard Deviation 11.9
Complete Utterances in Discourse
Post-treatment
46.7 percentage of complete utterances
Standard Deviation 16.0
Complete Utterances in Discourse
3 months post-treatment (maintenance)
47.9 percentage of complete utterances
Standard Deviation 13.8

SECONDARY outcome

Timeframe: pre-treatment and post-treatment

Confrontation naming of 162 objects

Outcome measures

Outcome measures
Measure
Verb Network Strengthening Treatment
n=11 Participants
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.
Noun Naming
Pre-treatment
79.9 percentage of correct naming
Standard Deviation 12.3
Noun Naming
Post-treatment
85.1 percentage of correct naming
Standard Deviation 12.6

SECONDARY outcome

Timeframe: pre-treatment and post-treatment

Confrontation of 100 action pictures

Outcome measures

Outcome measures
Measure
Verb Network Strengthening Treatment
n=11 Participants
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.
Verb Naming
Pre-treatment
64.6 percentage of correct naming
Standard Deviation 18.2
Verb Naming
Post-treatment
74.2 percentage of correct naming
Standard Deviation 16.0

SECONDARY outcome

Timeframe: pre-treatment and post-treatment

Standardized measure of aphasia severity

Outcome measures

Outcome measures
Measure
Verb Network Strengthening Treatment
n=11 Participants
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.
Western Aphasia Battery
Pre-treatment
75.9 units on a scale
Standard Deviation 10.4
Western Aphasia Battery
Post-treatment
82.1 units on a scale
Standard Deviation 8.6

SECONDARY outcome

Timeframe: pre-treatment, post-treatment and 3-months post-treatment (maintenance)

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.

Outcome measures

Outcome measures
Measure
Verb Network Strengthening Treatment
n=9 Participants
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.
Communicative Effectiveness Ratings
Pre-treatment
32.6 units on a scale
Standard Deviation 9.7
Communicative Effectiveness Ratings
Post-treatment
65.3 units on a scale
Standard Deviation 11.2
Communicative Effectiveness Ratings
3 months post-treatment (maintenance)
58.3 units on a scale
Standard Deviation 15.6

Adverse Events

Verb Network Strengthening Treatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lisa Edmonds, PhD

Brain Rehabilitation Research Center, Malcom Randall VA, Gainesville, FL

Phone: 352.262.4465

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place