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AERs in Aphasia: Severity and Improvement

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00013442
First received: March 14, 2001
Last updated: January 20, 2009
Last verified: January 2001

March 14, 2001
January 20, 2009
January 2000
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Complete list of historical versions of study NCT00013442 on ClinicalTrials.gov Archive Site
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AERs in Aphasia: Severity and Improvement
AERs in Aphasia: Severity and Improvement

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.

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.

Observational
Time Perspective: Prospective
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Stroke
Procedure: Auditory Evoked Response
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2002
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Stroke patients

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00013442
C2133R
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Department of Veterans Affairs
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Investigator: John Fryer, Ph.D., Asst. Director Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Investigator: Nancy Rocheleau, Program Analyst Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Department of Veterans Affairs
January 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP