NCT00494520

Brief Summary

Adults who sustain brain damage due to stroke, traumatic injury or surgery may develop difficulty finding words. This study compares the effectiveness of two behavior-based programs to improve picture naming ability in these individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2004

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 19, 2017

Status Verified

April 1, 2014

Enrollment Period

4.9 years

First QC Date

June 28, 2007

Last Update Submit

September 15, 2017

Conditions

Keywords

AnomiaAphasiaTraumatic Brain InjuryCerebrovascular Accident

Outcome Measures

Primary Outcomes (1)

  • Improved picture naming of trained words.

    Overall accuracy of named trained items

    Following conclusion of word treatment.

Secondary Outcomes (3)

  • Improved picture naming of trained words.

    At 6 months after conclusion of word treatment

  • Improved picture naming of untrained words.

    Following conclusion of word treatment.

  • Improved picture naming of untrained words.

    At 6 months after conclusion of word treatment

Study Arms (2)

Errorful training condition

EXPERIMENTAL

A type of anomia rehabilitation paradigm which allows for errors. The intervention involves providing minimal auditory cues to allow for errors in picture naming.

Procedure: Errorful training condition

Errorless training condition

EXPERIMENTAL

A type of anomia rehabilitation paradigm in which the situation surrounding the performance of the desired task (i.e., picture naming) is controlled to prevent errors. The intervention involves providing maximal auditory cues to prevent errors in picture naming.

Procedure: Errorless training condition

Interventions

Errorful training condition: Participant saw a picture and named it without any cues. If an error was produced, the cue with the least amount of information was provided (e.g. for "pumpkin", "pu"). Cues with increasing information were provided until the picture was correctly named (e.g. for "pumpkin": "pump", "pumpki", then "pumpkin"). Once the correct name was provided, the trial ended.

Errorful training condition

Errorless learning (EL) condition: Participant saw a picture with its name, and repeated the word. The participant continued to name the picture as the auditory cues provided less and less of the word (e.g. for "banana" she would hear "banan", "bana" then "ba" and finally no cue). If an error was produced at any stage, the whole word was presented, the participant repeated it, and the trial ended.

Errorless training condition

Eligibility Criteria

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

You may qualify if:

  • Word finding difficulty subsequent to stroke, traumatic brain injury, brain surgery or other brain damage occuring at least 6 month prior to participation
  • Ability to attend 2 sessions per week for several months at Georgetown University in Washington, DC

You may not qualify if:

  • History of learning disabilities
  • Best corrected vision less than 20/40
  • Corrected hearing within functional limits
  • Less than 10 years formal education
  • Significant memory or comprehension problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20057, United States

Location

Related Links

MeSH Terms

Conditions

AnomiaAphasiaBrain Injuries, TraumaticStroke

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpeech DisordersBrain InjuriesBrain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Rhonda B. Friedman, Ph.D.

    Georgetown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2007

First Posted

June 29, 2007

Study Start

July 1, 2004

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

September 19, 2017

Record last verified: 2014-04

Data Sharing

IPD Sharing
Will not share

Locations