fMRI of Language Recovery Following Stroke in Adults
| Tracking Information | |||||
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| First Received Date ICMJE | February 12, 2009 | ||||
| Last Updated Date | February 28, 2013 | ||||
| Start Date ICMJE | September 2008 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Primary outcome measure is aphasia improvement. In young and old adults, longitudinal changes in language activation patterns will be mapped & language localization and lateralization will be determined using fMRI after stroke [ Time Frame: 2 weeks after stroke, at 5-6 weeks, 3 months, 6 months and 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00843427 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | fMRI of Language Recovery Following Stroke in Adults | ||||
| Official Title ICMJE | fMRI of Language Recovery Following Stroke in Adults | ||||
| Brief Summary | The purpose of this study is to learn how language difficulties caused by stroke improve and test the effectiveness of constraint-induced aphasia therapy. |
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| Detailed Description | Aphasia (difficulty speaking) is one of the most dreaded consequences of stroke. It is associated with high mortality and severe motor, social, and cognitive disability. During the past decade, therapies administered by stroke teams have made great strides in limiting the damage due to a stroke. Unfortunately, progress in aphasia rehabilitation has not experienced the same rapid advancement. Evidence suggests that the brain may have untapped potential for recovery of aphasia after stroke. Using functional magnetic resonance imaging (fMRI), researchers now are able to examine the areas of the brain that are responsible for language recovery after stroke. Such data may explain how the brain recovers after stroke, and may lead to new therapies to help individuals who have suffered an aphasia-causing stroke. In this study, researchers will examine the changes the brain undergoes while recovering from an aphasia-causing stroke and the mechanisms that underlie such recovery, and test the effectiveness of a new and promising method of aphasia rehabilitation called constraint-induced aphasia therapy (CIAT). The scientists will perform fMRI studies of brain activation in people who have suffered an aphasia-causing stroke in order to better understand the underlying mechanisms of recovery from aphasia. Specifically the researchers will compare language activation between adults with stroke and children with perinatal and postnatal stroke (from previous studies); map changes in language activation, characterize the patterns of language reorganization that occur following stroke; and use the fMRI measures to assess recovery using CIAT. The study will last one year, during this time participants will have language testing to evaluate the degree of aphasia and its recovery; and five fMRI scans scheduled at 2 weeks, 6 weeks, 12 weeks, 26 weeks, and 56 weeks. Participants with remaining moderate aphasia will be offered a chance to participate in an extension treatment study that will last up to 3 months. A better understanding of brain changes during recovery from aphasia may help develop new methods to improve recovery. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | The study population will be selected from the University of Cincinnati Hospital, The Drake Center, and the St. Elizabeth South Hospital. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Estimated Completion Date | July 2013 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria for HEALTHY CONTROL group:
Exclusion Criteria for HEALTHY CONTROL group:
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| Gender | Both | ||||
| Ages | 19 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00843427 | ||||
| Other Study ID Numbers ICMJE | R01NS048281, 1RO1NS048281-01A2 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jerzy P Szaflarski, University of Alabama at Birmingham | ||||
| Study Sponsor ICMJE | University of Alabama at Birmingham | ||||
| Collaborators ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Alabama at Birmingham | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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