Speech and Language Therapy After Stroke
Primary Purpose
Ischemic Stroke
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Imitate Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring stroke, aphasia, imitation, mirror neuron
Eligibility Criteria
Inclusion Criteria:
- Single ischemic infarction in the MCA territory involving the cerebral cortex (confirmed by CT or MRI)
- Aphasia
- Visual attention and language comprehension sufficient to perform imitation fMRI tasks
- Right handed (prior to stroke)
Exclusion Criteria:
Exclusions to the study are people with cardiac pacemakers, claustrophobia, neurosurgical clips, or cognitive impairments too severe to permit cooperation with cognitive tasks in an MRI scanner.
Sites / Locations
- Solodkin/Small Brain Circuits Laboratory
- University of California Irvine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
Computer-based Aphasia therapy
Control Arm - Healthy subjects.
Outcomes
Primary Outcome Measures
Changes in scores on Western Aphasia Battery
Secondary Outcome Measures
Full Information
NCT ID
NCT00713050
First Posted
July 9, 2008
Last Updated
June 10, 2013
Sponsor
University of Chicago
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), Shirley Ryan AbilityLab
1. Study Identification
Unique Protocol Identification Number
NCT00713050
Brief Title
Speech and Language Therapy After Stroke
Official Title
Neurophysiological Measurement in Aphasia Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
Protocol expired; PI retired
Study Start Date
August 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), Shirley Ryan AbilityLab
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Our overall goal is to advance the state of functional brain imaging in aphasia, and then to apply the method to an intensive, imitation-based treatment for non-fluent aphasia.
Detailed Description
Detailed information will follow in the next progress report.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
stroke, aphasia, imitation, mirror neuron
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Computer-based Aphasia therapy
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control Arm - Healthy subjects.
Intervention Type
Behavioral
Intervention Name(s)
Imitate Therapy
Other Intervention Name(s)
Imitate
Intervention Description
Imitation-based computer therapy
Primary Outcome Measure Information:
Title
Changes in scores on Western Aphasia Battery
Time Frame
Four months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Single ischemic infarction in the MCA territory involving the cerebral cortex (confirmed by CT or MRI)
Aphasia
Visual attention and language comprehension sufficient to perform imitation fMRI tasks
Right handed (prior to stroke)
Exclusion Criteria:
Exclusions to the study are people with cardiac pacemakers, claustrophobia, neurosurgical clips, or cognitive impairments too severe to permit cooperation with cognitive tasks in an MRI scanner.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Small, M.D., Ph.D.
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Solodkin/Small Brain Circuits Laboratory
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27053642
Citation
Duncan ES, Schmah T, Small SL. Performance Variability as a Predictor of Response to Aphasia Treatment. Neurorehabil Neural Repair. 2016 Oct;30(9):876-82. doi: 10.1177/1545968316642522. Epub 2016 Apr 6.
Results Reference
derived
Learn more about this trial
Speech and Language Therapy After Stroke
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