fMRI of Language Recovery Following Stroke in Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Primary outcome measure is aphasia improvement.
Study Overview
Brief Summary
The purpose of this study is to test the effectiveness of constraint-induced aphasia therapy.
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 (STUDY).
A better understanding of brain changes during recovery from aphasia may help develop new methods to improve recovery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Aphasia - CIAT
Patients with aphasia >1 year after left MCA stroke who will be randomized to receive CIAT
Intervention: CIAT (Behavioral)
Aphasia - observation
Patients with aphasia >1 year after left MCA stroke who will be randomized to no intervention (observation)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Jerzy P Szaflarski
Professor
University of Alabama at Birmingham