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Treating Intention In Aphasia
This study is currently recruiting participants.
Verified by National Institute on Deafness and Other Communication Disorders (NIDCD), August 2008
Sponsored by: National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by: National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier: NCT00567242
  Purpose

The purpose of this study is to determine if an "intentional act" improves treatment response for patients with nonfluent aphasia. The treatment involves naming pictures and saying members of categories. The "intentional act" requires initiating picture naming or category member trials with a left-hand movement sequence. Nonfluent aphasia is a disorder of language production in which patients with damage to the brain's language system have trouble initiating and maintaining spoken communication. All patients participating in the study take part in functional MRI scans to determine how treatments affect brain systems.


Condition Intervention Phase
Aphasia
Cerebrovascular Accident
Behavioral: Intention treatment
Behavioral: Word finding
Phase I
Phase II

MedlinePlus related topics: Aphasia MRI Scans
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title: Treating Intention In Aphasia: Neuroplastic Substrates

Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

Primary Outcome Measures:
  • Lateralization of frontal lobe (and posterior perisylvian) activity during word production [ Time Frame: pre-treatment, post-treatment, 3-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Word-finding ability (picture-naming and category member generation accuracy) [ Time Frame: pre-treatment, post-treatment, 3-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: March 2007
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Word-finding trials with intention manipulation
Behavioral: Intention treatment
Word-finding trials are initiated with a complex left-hand movement.
2: Active Comparator
Word-finding trials without intention manipulation
Behavioral: Word finding
Word-finding trials are initiated without a complex left-hand movement.

Detailed Description:

A new treatment manipulating intention substrates for language production in "nonfluent" aphasia patients was developed. The intention component involves initiating word-finding trials with a complex left-hand movement. The study addresses (1) whether or not the intention manipulation (complex left-hand movement) makes a unique contribution to treatment outcome and (2) whether or not the intention manipulation helps to shift word production mechanisms from the left to the right frontal lobe. All study participants take part in functional magnetic resonance imaging (fMRI) scans of word-finding before and after treatment and at 3-month follow-up to measure changes in lateralization of frontal lobe activity during word finding. Only patients with a substantial degree of left frontal activity on the pre-treatment fMRI scan can participate. There are three specific aims: (1) to determine if repetitive initiation of word production with a complex left-hand movement leads to increased right-hemisphere lateralization of frontal activity and if these changes can be attributed to the intention component of treatment, (2) to determine whether activity in posterior perisylvian cortices that is entrained to right frontal activity shows a greater increase in right-hemisphere lateralization from pre- to post-treatment fMRI when the intention component is included in treatment, and (3) to determine whether onset of hemodynamic responses (HDRs) in right motor/premotor cortex becomes more closely associated with the temporal onset of participants' spoken responses across treatment when the intention component is included in treatment. If successful, the treatment can provide a new treatment vehicle for increasing language function in patients with "nonfluent" aphasia.

  Eligibility

Ages Eligible for Study:   21 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nonfluent aphasia caused by stroke
  • Moderate to severe word-finding problems
  • 6 or more months post stroke
  • Right handed prior to stroke
  • All strokes in left hemisphere
  • Native English speaker
  • Capable of following verbal directions

Exclusion Criteria:

  • Severe impairment of word comprehension
  • Brain injury or disease in addition to stroke
  • Drug or alcohol abuse within past 6 months
  • Schizophrenia or other psychiatric disorder necessitating hospitalization
  • History of learning disability
  • Claustrophobia
  • Cardiac pace-maker
  • Ferrous metal implants not attached to bone, metal fragments in body
  • Profound hearing loss
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567242

Contacts
Contact: Bruce Crosson, PhD nossorc1@phhp.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Michelle Benjamin, M.S.     352-376-1611 ext 5395     mlb27@phhp.ufl.edu    
Contact: Zvinka Zlatar, B.A.     352-376-1611 ext 5395     zvinka@ufl.edu    
Principal Investigator: Bruce Crosson, Ph.D.            
University of Florida/Shands Hospital Recruiting
Jacksonville, Florida, United States, 32209
Contact: Joellen Gilbert, M.S.     904-244-9057     joellen.gilbert@jax.ufl.edu    
Principal Investigator: Bruce Crosson, Ph.D.            
Brooks Center for Rehabilitation Studies Recruiting
Jacksonville, Florida, United States, 32216
Contact: Cecilia Brooks, M.Ed.     904-858-7260     cecilia.brooks@brookshealth.org    
Contact: Floris Singletary, M.S.     904-306-8973     fsinglet@phhp.ufl.edu    
Principal Investigator: Bruce Crosson, Ph.D.            
Sponsors and Collaborators
Investigators
Principal Investigator: Bruce Crosson, PhD University of Florida
  More Information

Brain Imaging, Rehabilitation, and Cognition laboratory website  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: University of Florida ( Bruce Crosson, Ph.D./Professor )
Study ID Numbers: R01DC007387-01A1
Study First Received: November 30, 2007
Last Updated: August 18, 2008
ClinicalTrials.gov Identifier: NCT00567242  
Health Authority: United States: Federal Government

Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):
aphasia
therapies, investigational
rehabilitation of speech and language disorders
magnetic resonance imaging, functional
language

Study placed in the following topic categories:
Speech Disorders
Cerebral Infarction
Aphasia
Stroke
Vascular Diseases
Central Nervous System Diseases
Language Disorders
Ischemia
Brain Diseases
Cerebrovascular Disorders
Signs and Symptoms
Neurologic Manifestations
Brain Ischemia
Brain Infarction
Infarction
Neurobehavioral Manifestations
Communication Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009