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fMRI of Language Recovery Following Stroke in Adults

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ClinicalTrials.gov Identifier: NCT00843427
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : April 12, 2017
Information provided by (Responsible Party):

February 12, 2009
February 13, 2009
April 12, 2017
September 2008
August 2015   (Final data collection date for primary outcome measure)
Primary outcome measure is aphasia improvement. [ Time Frame: 1 week and 3 months after intervention ]
The Token Test was used only for primary screening and study qualification. All participants received NAT which included: (1) the Boston Naming Test (BNT) (Kaplan, Goodglass et al. 1983), (2) the Controlled Oral Word Association Test (Lezak 1995), (3) the Semantic Fluency Test (SFT) (Kozora and Cullum 1995, Lezak 1995), (4) the Complex Ideation subtest from the Boston Diagnostic Aphasia Examination (BDAE) (Goodglass and Kaplan 1972), (5) the Peabody Picture Vocabulary Test III (PPVT III) (Dunn and Dunn 1997), and (6) the Mini-Communicative Activities Log (Mini-CAL) which is a subjective measure of communicative abilities (Pulvermuller, Neininger et al. 2001, Szaflarski, Ball et al. 2008).
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 ]
Complete list of historical versions of study NCT00843427 on ClinicalTrials.gov Archive Site
Not Provided
  • In participants with stroke, changes in language activation will be mapped using fMRI [ Time Frame: 2 weeks after stroke, at 5-6 weeks, 3 months, 6 months and 12 months ]
  • CIAT will be applied & fMRI & neuropsychological measures will be used to document the relationship between the clinical and anatomical correlates of post-stroke language recovery in people with stroke [ Time Frame: 2 weeks after stroke, at 5-6 weeks, 3 months, 6 months and 12 months ]
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fMRI of Language Recovery Following Stroke in Adults
fMRI of Language Recovery Following Stroke in Adults
The purpose of this study is to test the effectiveness of constraint-induced aphasia therapy.

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 (STUDY).

A better understanding of brain changes during recovery from aphasia may help develop new methods to improve recovery.

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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Aphasia
  • Stroke
Behavioral: 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 Name: CILT
  • Experimental: Aphasia - CIAT
    Patients with aphasia >1 year after left MCA stroke who will be randomized to receive CIAT
    Intervention: Behavioral: CIAT
  • No Intervention: Aphasia - observation
    Patients with aphasia >1 year after left MCA stroke who will be randomized to no intervention (observation)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2015
August 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • MCA stroke as indicated by the presence of aphasia and MRI lesion in the LMCA distribution
  • Moderate aphasia (Token Test score between 40th and 90th percentile)
  • Written informed consent by the patient or the next of kin

Exclusion Criteria:

  • Underlying degenerative or metabolic disorder or supervening medical illness
  • Severe depression or other psychiatric disorder
  • Pregnancy
  • Any contraindication to an MRI procedure (i.e., metal implants, claustrophobia)
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01NS048281( U.S. NIH Grant/Contract )
1R01NS048281-01A2 ( U.S. NIH Grant/Contract )
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Jerzy P Szaflarski, University of Alabama at Birmingham
University of Alabama at Birmingham
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Jerzy P. Szaflarski, MD, PhD University of Alabama at Birmingham, Department of Neurology
University of Alabama at Birmingham
April 2017

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