fMRI of Language Recovery Following Stroke in Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jerzy P Szaflarski, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00843427
First received: February 12, 2009
Last updated: July 3, 2014
Last verified: July 2014

February 12, 2009
July 3, 2014
September 2008
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00843427 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 or at 5-6 weeks after stroke , 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
fMRI of Language Recovery Following Stroke in Adults
fMRI of Language Recovery Following Stroke in Adults

The purpose of this study is to learn how language difficulties caused by stroke improve and 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.

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

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

The study population will be selected from the University of Cincinnati Hospital, The Drake Center, and the St. Elizabeth South Hospital.

  • Aphasia
  • Stroke
Not Provided
  • Aphasia
    The aphasia group will have left middle cerebral artery (LMCA) stroke with moderate aphasia.
  • Control
    The control group will be healthy with no aphasia or stroke.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
December 2014
December 2014   (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)

Inclusion Criteria for HEALTHY CONTROL group:

  • Written informed consent by the subject

Exclusion Criteria for HEALTHY CONTROL group:

  • History of degenerative or metabolic disorder or supervening medical illness
  • Previous medical history positive for neurological or mental illness
  • Pregnancy
  • Any contraindication to an MRI procedure (i.e., metallic implants, claustrophobia)
Both
19 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00843427
R01NS048281, 1RO1NS048281-01A2
No
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
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP