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| Name | Class |
|---|---|
| U.S. Department of Education | FED |
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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 (i.e. difficulty with the comprehension and expression of spoken and written language) following a stroke.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levodopa/carbidopa | Active Comparator | 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. |
|
| Inactive pill | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levodopa/carbidopa | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Language Quotient (LQ) on the Western Aphasia Battery | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Communication Skills | Scores derived from language sample analyses | Change from Baseline in functional communication skills at 6 weeks |
| Participation in Everyday Activities | Measures on CETI, QCL,BOSS, CCRSA. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Aphasia Research & Treatment | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Levodopa | The study drug (100 mg levodopa / 25 mg carbidopa), was received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks. |
| FG001 | Inactive Pill | The inactive pill was received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levodopa | |
| BG001 | Inactive Pill | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Language Quotient (LQ) on the Western Aphasia Battery | 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. | Posted | Mean | Standard Deviation | units on a scale | Change from Baseline in Western Aphasia Battery LQ at 6 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levodopa |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leora R. Cherney, PhD | Rehabilitation Institute of Chicago | 312-238-1117 | Lcherney@ric.org |
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| ID | Term |
|---|---|
| D001039 | Aphasia, Broca |
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D001037 | Aphasia |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
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|
| Placebo comparator | Drug | 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. |
|
| Change from Baseline in participation in everyday activities at 6 weeks |
| Western Aphasia Battery - Reading and Writing Scores | Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks |
| Western Aphasia Battery Aphasia Quotient (Maintenance) | Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks |
| Western Aphasia Battery Reading and Writing Scores (Maintenance) | Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks |
| Functional Communication Skills (Maintenance) | Change in functional communication skills from 6 weeks to 12 weeks |
| Participation in Everyday Activities (Maintenance) | Change in participation in everyday activities from 6 weeks to 12 weeks |
Total of all reporting groups
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Functional Communication Skills | Scores derived from language sample analyses | Not Posted | Change from Baseline in functional communication skills at 6 weeks |
| Secondary | Participation in Everyday Activities | Measures on CETI, QCL,BOSS, CCRSA. | Not Posted | Change from Baseline in participation in everyday activities at 6 weeks |
| Secondary | Western Aphasia Battery - Reading and Writing Scores | Not Posted | Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks |
| Secondary | Western Aphasia Battery Aphasia Quotient (Maintenance) | Not Posted | Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks |
| Secondary | Western Aphasia Battery Reading and Writing Scores (Maintenance) | Not Posted | Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks |
| Secondary | Functional Communication Skills (Maintenance) | Not Posted | Change in functional communication skills from 6 weeks to 12 weeks |
| Secondary | Participation in Everyday Activities (Maintenance) | Not Posted | Change in participation in everyday activities from 6 weeks to 12 weeks |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Inactive Pill | 0 | 14 | 0 | 14 |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |