Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00467103
Status:
COMPLETED
Last Update Posted:
2022-03-24
First Post:
2007-04-25
Brief Title:
Neural Networks and Language Recovery in Aphasia From Stroke fMRI Studies
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Neural Networks and Language Recovery in Aphasia From Stroke fMRI Studies
Status:
COMPLETED
Status Verified Date:
2022-03
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:
The purpose of this research is to utilize functional magnetic resonance imaging fMRI to investigate brain reorganization for language behavior in stroke patients with aphasia A primary focus of the study is on recovery of nonfluent propositional speech and naming in chronic aphasia patients The fMRI technique is used to examine activation in the left hemisphere LH and right hemisphere RH during recovery of specific language behaviors in chronic nonfluent aphasia patients
Detailed Description:
PURPOSE The purpose of this 4-year fMRI research is to study brain reorganization for language in patients with left hemisphere LH stroke who have chronic nonfluent aphasia This fMRI research is fundamental and critical to the PIs NIH RO1 grant Transcranial Magnetic Stimulation TMS to Improve Speech in nonfluent aphasia which was recently renewed for 5 years 2006-11 There is no overlap in the studies The NIH grant provides the TMS real and sham This VA grant provides 4 different fMRI tasks performed pre- and post- a series of TMS treatments real and sham - Overt Naming fMRI Overt Propositional Speech fMRI and Nonverbal Semantic Decision tasks for Nouns and for Actions
The investigators have observed that application of TMS to an anterior portion of right R Brocas homologue pars triangularis PTr results in significantly improved picture naming ability at 2 and 8 Mo after the last 10th TMS treatment in aphasia patients who began TMS at 5-11 years poststroke Also half of these nonfluent aphasia patients improved their Phrase Length in propositional speech post-TMS
RATIONALE The investigators and others have observed that patients with chronic nonfluent aphasia poor hesitant speech have overactivation of R hemisphere RH cortical language homologues The investigators hypothesize this represents a maladaptive plasticity and probably poor active inhibition during speech Slow 1 Hz TMS can be used to suppress cortical excitability The goal is to use 1 Hz TMS to inhibitsuppress the overactivation in RH language homologues The investigators early TMS research has shown that suppression of R PTr in these patients is associated with improved speech The fMRI studies proposed in this VA grant will help to investigate the neurophysiological changes underlying improvement post- TMS in propositional speech and in nonverbal semantic decision tasks The new MRI technique diffusion tensor imaging DTI will be used to study WM pathways subjacent to cortex treated with TMS
DESIGN Randomized sham-control incomplete crossover design with 32 patients 16 mild-moderate 16 severe nonfluent half receive real TMS series only half sham TMS 1st and real 2nd Language Neuropsych testing and fMRIs are performed at Entry and at 2 Mo post-10 real or sham TMS treatments and at 6 Mo post real There are 4 Projects 1 fMRI during overt naming and propositional speech Overt Picture Naming and Picture DescriptionsStory Telling 2 fMRI during a Nonverbal Semantic Decision Task with Superordinate Noun Icons 3 fMRI during a Nonverbal Semantic Decision Task with Action and Object Icons 4 DTI DTI is performed only at Entry all subjects Normal controls n8 do not receive TMS they are studied with fMRI at Entry at 2 and 6 Mo later
HYPOTHESES Following the real TMS to suppress R PTr there will be less overactivation on fMRI better modulation in RH language homologues and new LH activation including L perilesional areas and L SMA This will be associated with improved propositional speech BDAE and nonverbal semantic decision ability at 2 and 6 Mo post-real TMS No language or fMRI changes are expected post-sham TMS The fMRIs performed 3x with the normal controls are not expected to show change but will document the neural networks for the fMRI tasks
The investigators have observed that application of TMS to an anterior portion of right R Brocas homologue pars triangularis PTr results in significantly improved picture naming ability at 2 and 8 Mo after the last 10th TMS treatment in aphasia patients who began TMS at 5-11 years poststroke Also half of these nonfluent aphasia patients improved their Phrase Length in propositional speech post-TMS
RATIONALE The investigators and others have observed that patients with chronic nonfluent aphasia poor hesitant speech have overactivation of R hemisphere RH cortical language homologues The investigators hypothesize this represents a maladaptive plasticity and probably poor active inhibition during speech Slow 1 Hz TMS can be used to suppress cortical excitability The goal is to use 1 Hz TMS to inhibitsuppress the overactivation in RH language homologues The investigators early TMS research has shown that suppression of R PTr in these patients is associated with improved speech The fMRI studies proposed in this VA grant will help to investigate the neurophysiological changes underlying improvement post- TMS in propositional speech and in nonverbal semantic decision tasks The new MRI technique diffusion tensor imaging DTI will be used to study WM pathways subjacent to cortex treated with TMS
DESIGN Randomized sham-control incomplete crossover design with 32 patients 16 mild-moderate 16 severe nonfluent half receive real TMS series only half sham TMS 1st and real 2nd Language Neuropsych testing and fMRIs are performed at Entry and at 2 Mo post-10 real or sham TMS treatments and at 6 Mo post real There are 4 Projects 1 fMRI during overt naming and propositional speech Overt Picture Naming and Picture DescriptionsStory Telling 2 fMRI during a Nonverbal Semantic Decision Task with Superordinate Noun Icons 3 fMRI during a Nonverbal Semantic Decision Task with Action and Object Icons 4 DTI DTI is performed only at Entry all subjects Normal controls n8 do not receive TMS they are studied with fMRI at Entry at 2 and 6 Mo later
HYPOTHESES Following the real TMS to suppress R PTr there will be less overactivation on fMRI better modulation in RH language homologues and new LH activation including L perilesional areas and L SMA This will be associated with improved propositional speech BDAE and nonverbal semantic decision ability at 2 and 6 Mo post-real TMS No language or fMRI changes are expected post-sham TMS The fMRIs performed 3x with the normal controls are not expected to show change but will document the neural networks for the fMRI tasks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None