NCT01300624

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2011

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
11 months until next milestone

Results Posted

Study results publicly available

June 9, 2015

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

2.8 years

First QC Date

January 21, 2011

Results QC Date

July 15, 2014

Last Update Submit

June 5, 2015

Conditions

Keywords

Aphasiatherapytreatmentverbssentences

Outcome Measures

Primary Outcomes (3)

  • Trained Sentence Probe

    Picture description task that include trained words.

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

  • Untrained Sentence Probes

    Picture description with sentences containing untrained words.

    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

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

Secondary Outcomes (4)

  • Noun Naming

    pre-treatment and post-treatment

  • Verb Naming

    pre-treatment and post-treatment

  • Western Aphasia Battery

    pre-treatment and post-treatment

  • Communicative Effectiveness Ratings

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

Study Arms (1)

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.

Behavioral: Verb Network Strengthening Treatment

Interventions

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
Verb Network Strengthening Treatment

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans with a diagnosis of aphasia
  • primary language is English
  • aphasia due to stroke

You may not qualify if:

  • Functionally bilingual

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Lisa Edmonds, PhD
Organization
Brain Rehabilitation Research Center, Malcom Randall VA, Gainesville, FL

Study Officials

  • Lisa A. Edmonds, PhD

    North Florida/South Georgia Veterans Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2011

First Posted

February 21, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2013

Study Completion

July 1, 2014

Last Updated

June 9, 2015

Results First Posted

June 9, 2015

Record last verified: 2015-06

Locations