- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01429077
Augmenting Language Therapy for Aphasia: Levodopa
Augmenting Language Therapy for Aphasia: A Randomized Double-Blind Placebo-Controlled Trial of Levodopa in Combination With Speech-Language Therapy
Study Overview
Status
Conditions
Intervention / Treatment
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 approximately 4.8 million with approximately 700,000 additional strokes occurring annually. Approximately 150,000 to 250,000 stroke survivors becoming severely and permanently disabled each year.
A common neurological deficit among stroke survivors, and thus a substantial contributor to post-stroke disability, is aphasia. The loss of, or difficulty with language is extremely debilitating and has enormous social and economic impact on quality of life. Presently, the only treatment available for persons with aphasia is speech-language rehabilitation.
With rehabilitation only, however, many patients achieve a less than satisfactory improvement in speech-language function, and thus are left with significant disability.
To enhance motor and language recovery in patients with neurological impairments, interest in the use of novel biological therapies, including pharmacological agents, has recently emerged. There is preliminary evidence that increased levels of dopamine, in combination with language treatment, may improve the deficits of aphasia following stroke. Most studies have investigated the adjunctive effects of the dopamine agonist bromocriptine, with mixed results. However, new evidence is suggesting that levodopa, a precursor to dopamine, may be more effective in promoting language learning.
This study proposes to evaluate the effectiveness of levodopa in study subjects with Broca's aphasia after stroke, delivered concurrent with speech-language rehabilitation.
The language changes in subjects who receive speech and language therapy combined with levodopa will be compared to that of subjects who receive the same speech-language rehabilitation but with a placebo (i.e. a pill that does not contain the study drug, levodopa). The two study groups will be compared to determine the degree to which improvements in language performance occur and the degree to which they are maintained over time.
The protocol is double-blind: neither subjects nor researchers will know whether a subject took levodopa or placebo until the study's conclusion.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Center for Aphasia Research & Treatment
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Levodopa/carbidopa
The study drug (100 mg levodopa / 25 mg carbidopa), is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
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The study drug (100 mg levodopa / 25 mg carbidopa), is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
Other Names:
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PLACEBO_COMPARATOR: Inactive pill
The placebo comparator (inactive pill) is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
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The placebo comparator (inactive pill) is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Language Quotient (LQ) on the Western Aphasia Battery
Time Frame: Change from Baseline in Western Aphasia Battery LQ at 6 weeks
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Includes a measure of auditory comprehension, oral expression, reading and written expression skills. The scale ranges from 1 - 100 with 100 being better. The change or gain score from baseline to immediately post-treatment (at 6 weeks) is reported. The larger the change score, the greater the improvement. |
Change from Baseline in Western Aphasia Battery LQ at 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Communication Skills
Time Frame: Change from Baseline in functional communication skills at 6 weeks
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Scores derived from language sample analyses
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Change from Baseline in functional communication skills at 6 weeks
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Participation in Everyday Activities
Time Frame: Change from Baseline in participation in everyday activities at 6 weeks
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Measures on CETI, QCL,BOSS, CCRSA.
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Change from Baseline in participation in everyday activities at 6 weeks
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Western Aphasia Battery - Reading and Writing Scores
Time Frame: Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks
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Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks
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Western Aphasia Battery Aphasia Quotient (Maintenance)
Time Frame: Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks
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Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks
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Western Aphasia Battery Reading and Writing Scores (Maintenance)
Time Frame: Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks
|
Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks
|
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Functional Communication Skills (Maintenance)
Time Frame: Change in functional communication skills from 6 weeks to 12 weeks
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Change in functional communication skills from 6 weeks to 12 weeks
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Participation in Everyday Activities (Maintenance)
Time Frame: Change in participation in everyday activities from 6 weeks to 12 weeks
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Change in participation in everyday activities from 6 weeks to 12 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Language Disorders
- Communication Disorders
- Speech Disorders
- Aphasia
- Aphasia, Broca
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Aromatic Amino Acid Decarboxylase Inhibitors
- Levodopa
- Carbidopa
Other Study ID Numbers
- H133G070074
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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