AERs in Aphasia: Severity and Improvement

January 20, 2009 updated by: US Department of Veterans Affairs
Over one million persons in the United States are aphasic subsequent to a stroke. Most of the individuals improve through spontaneous recovery and treatment. However, there are no precise methods for predicting which patients will improve and, for those who do, how much improvement will occur. There is a need to improve prognostic precision in aphasia. The purpose of this investigation is to test the precision of auditory evoked responses (AERs) to provide a prognosis for improvement in aphasia subsequent to a left hemisphere thromboembolic infarct. We hypothesize that the presence, absence, and pattern of the AER responses will predict severity of aphasia and prognosis for improvement. Phonemic, phonologic, semantic, and syntactic language tasks will be used to elicit AERs, including the auditory late response, the mismatch negativity response (MMN), the N400, and the P600.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Over one million persons in the United States are aphasic subsequent to a stroke. Most of the individuals improve through spontaneous recovery and treatment. However, there are no precise methods for predicting which patients will improve and, for those who do, how much improvement will occur. There is a need to improve prognostic precision in aphasia. Currently employed prognostic methods miss improvement levels by substantial margins. Prognostic information could have a great economic and social impact on patients, their families, and their treatment.

The purpose of this investigation is to test the precision of auditory evoked responses (AERs) to provide a prognosis for improvement in aphasia subsequent to a left hemisphere thromboembolic infarct. We hypothesize that the presence, absence, and pattern of the AER responses will predict severity of aphasia and prognosis for improvement. Phonemic, phonologic, semantic, and syntactic language tasks will be used to elicit AERs, including the auditory late response, the mismatch negativity response (MMN), the N400, and the P600. Twenty moderately aphasic subjects, 20 severely aphasic subjects, and 20 age-matched, normal subjects will be tested. All aphasic subjects will be evaluated with the AER test battery and a language test battery: Western Aphasia Battery (WAB), Porch Index of Communicative Ability (PICA), the Token Test (TT), the Auditory Comprehension Test for Sentences (ACTS), and the ASHA Functional Assessment of Communication Skills for Adults (ASHA FACS). All tests will be repeated in 6 and 12 weeks, during which the aphasic subjects will receive treatment. Aphasic subjects will receive follow-up testing 3 and 6 months after the treatment phase is completed. The patterns of the AERs will be examined. Correlations and analyses of variance (ANOVAs) will be used to assess the relationships between AER measures and improvement in aphasia quantified by behavioral measures. A multiple regression technique will be used to determine the best predictor(s) of improvement in aphasia. Correlations and analyses of variance (ANOVAs) will be used to assess the relationship between AER measures and severity of aphasia. Correlations and assessment of composite CT/MRI reconstructions for subject groups will be used to determine the relationship between size (correlations) and site of lesion, AERs, and severity and improvement in aphasia.

Study Type

Observational

Enrollment

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tennessee
      • Nashville, Tennessee, United States
        • VAMC, Nashville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Stroke patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Nancy Rocheleau, Program Analyst, Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
  • John Fryer, Ph.D., Asst. Director, Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Study Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

March 14, 2001

First Submitted That Met QC Criteria

March 15, 2001

First Posted (Estimate)

March 16, 2001

Study Record Updates

Last Update Posted (Estimate)

January 21, 2009

Last Update Submitted That Met QC Criteria

January 20, 2009

Last Verified

January 1, 2001

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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