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
  Purpose

The purpose of this study is to learn how language difficulties caused by stroke improve and test the effectiveness of constraint-induced aphasia therapy.


Condition
Aphasia
Stroke

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: fMRI of Language Recovery Following Stroke in Adults

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: September 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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)

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843427

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Jerzy P. Szaflarski, MD, PhD University of Alabama at Birmingham, Department of Neurology
  More Information

Publications:

Responsible Party: Jerzy P Szaflarski, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00843427     History of Changes
Other Study ID Numbers: R01NS048281, 1RO1NS048281-01A2
Study First Received: February 12, 2009
Last Updated: July 3, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Alabama at Birmingham:
aphasia
stroke
functional magnetic resonance imaging
fMRI
language recovery after stroke
constraint-induced aphasia therapy
CIAT

Additional relevant MeSH terms:
Aphasia
Stroke
Cerebral Infarction
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 24, 2014