Study Results
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Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2008-09-30
2015-08-31
Brief Summary
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Detailed Description
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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 (STUDY).
A better understanding of brain changes during recovery from aphasia may help develop new methods to improve recovery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Aphasia - CIAT
Patients with aphasia \>1 year after left MCA stroke who will be randomized to receive CIAT
CIAT
Patients are to receive constraint-induced aphasia therapy for 2 weeks at 4 hours per day. Detailed description of this intervention is in Szaflarski et al., 2015 Medical Science Monitor.
Aphasia - observation
Patients with aphasia \>1 year after left MCA stroke who will be randomized to no intervention (observation)
No interventions assigned to this group
Interventions
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CIAT
Patients are to receive constraint-induced aphasia therapy for 2 weeks at 4 hours per day. Detailed description of this intervention is in Szaflarski et al., 2015 Medical Science Monitor.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate aphasia (Token Test score between 40th and 90th percentile)
* Written informed consent by the patient or the next of kin
Exclusion Criteria
* Severe depression or other psychiatric disorder
* Pregnancy
* Any contraindication to an MRI procedure (i.e., metal implants, claustrophobia)
19 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Jerzy P Szaflarski
Professor
Principal Investigators
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Jerzy P. Szaflarski, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham, Department of Neurology
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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References
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Jacola LM, Schapiro MB, Schmithorst VJ, Byars AW, Strawsburg RH, Szaflarski JP, Plante E, Holland SK. Functional magnetic resonance imaging reveals atypical language organization in children following perinatal left middle cerebral artery stroke. Neuropediatrics. 2006 Feb;37(1):46-52. doi: 10.1055/s-2006-923934.
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Muller RA, Rothermel RD, Behen ME, Muzik O, Chakraborty PK, Chugani HT. Language organization in patients with early and late left-hemisphere lesion: a PET study. Neuropsychologia. 1999 May;37(5):545-57. doi: 10.1016/s0028-3932(98)00109-2.
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