Status:
COMPLETED
Assessment of Cortical Stimulation Combined With Rehabilitation to Enhance Recovery in Broca's Aphasia.
Lead Sponsor:
Northstar Neuroscience
Conditions:
Stroke
Broca's Aphasia
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
The primary objective of this feasibility study is to evaluate the safety and effectiveness of targeted sub-threshold epidural cortical stimulation delivered concurrent with speech-language rehabilita...
Detailed Description
Stroke is the third leading cause of death and the most common cause of disability in the United States. According to the American Stroke Association, the prevalence of stroke in the U.S. is approxima...
Eligibility Criteria
Inclusion
- Subjects must have an ischemic stroke.
- Subjects must have a language dominant left hemisphere.
- Subjects must be diagnosed as having predominantly Broca's aphasia.
- Age 21 years or older.
Exclusion
- Primary hemorrhagic stroke.
- Any additional stroke associated with incomplete speech recovery.
- Any neurologic or physical condition that impairs speech function.
- History of seizure disorder.
- Global aphasia or inability to participate in routine speech therapy.
- Untreated or inadequately treated depression.
- History of traumatic brain injury, or spontaneous subdural or epidural hematoma that has resulted in a fixed (stable) speech-language deficit.
- Major active psychiatric illness that may interfere with required study procedures.
- Contraindication to magnetic resonance (MR) imaging.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00170703
Start Date
December 1 2004
End Date
September 1 2007
Last Update
September 21 2007
Active Locations (2)
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1
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
2
Univ. of Chicago
Chicago, Illinois, United States, 60637