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
  Purpose

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.


Condition Intervention Phase
Stroke
Procedure: Auditory Evoked Response
Phase 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: AERs in Aphasia: Severity and Improvement

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 20
Study Start Date: January 2000
Study Completion Date: December 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Stroke patients

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00013442

Locations
United States, Tennessee
VAMC, Nashville
Nashville, Tennessee, United States
Sponsors and Collaborators
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00013442     History of Changes
Other Study ID Numbers: C2133R
Study First Received: March 14, 2001
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Aphasia, auditory evoked, aging

Additional relevant MeSH terms:
Aphasia
Communication Disorders
Language Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Speech Disorders

ClinicalTrials.gov processed this record on October 23, 2014