Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013442
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2001-03-14
Brief Title:
AERs in Aphasia Severity and Improvement
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
AERs in Aphasia Severity and Improvement
Status:
COMPLETED
Status Verified Date:
2001-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 predictors 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 CTMRI 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
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 predictors 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 CTMRI 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None