Status:
COMPLETED
Augmenting Language Therapy for Aphasia: Levodopa
Lead Sponsor:
Shirley Ryan AbilityLab
Collaborating Sponsors:
U.S. Department of Education
Conditions:
Nonfluent Aphasia
Stroke
Eligibility:
All Genders
21+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness of the medication levodopa, in combination with speech-language treatment, on the language outcome of study subjects with nonfluent aphasia (...
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
- A single unilateral left-hemisphere stroke
- Nonfluent aphasia, with a mean length of utterance of 0-4 words and an Aphasia Quotient between 20 and 75 on the Western Aphasia Battery
- Age 21 or older.
- At least 6 months post-stroke
- Able to comply with the study protocol
- Premorbidly right-handed, as determined by the Edinburgh Handedness Inventory
- Fluent in English premorbidly
- Completed at least 8th grade education
Exclusion
- More than one stroke
- Any other neurological condition that could potentially affect cognition or speech.
- Global aphasia or inability to participate in routine speech therapy.
- Major active psychiatric illness that may interfere with required study procedures.
- Untreated or inadequately treated depression.
- Has started taking a potentially confounding central nervous system (CNS) drug within the previous 2 months.
- Current abuse of alcohol or drugs
- Nursing a child or pregnant
- Participation in another drug, device or biologics trial within the preceding 90 days
- Unable to understand, cooperate or comply with study procedures
- Significant visual or auditory impairment
- History of sensitivity to ergot derivatives.
- Active medical illness or current medication that precludes safe participation in this study.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01429077
Start Date
October 1 2007
End Date
March 1 2012
Last Update
December 25 2013
Active Locations (1)
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1
Center for Aphasia Research & Treatment
Chicago, Illinois, United States, 60611