Clinical trial NCT00843427: fMRI of Language Recovery Following Stroke in Adults
Official title: fMRI of Language Recovery Following Stroke in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Stroke
Keywords: aphasia
stroke
functional magnetic resonance imaging
fMRI
language recovery after stroke
constraint-induced aphasia therapy
CIAT
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2009-02-13
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Primary outcome measure is aphasia improvement.
timeFrame: 1 week and 3 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham, Department of Neurology
name: Jerzy P. Szaflarski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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