Clinical Trial: Augmenting Language Therapy for Aphasia: Levodopa

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Augmenting Language Therapy for Aphasia: A Randomized Double-Blind Placebo-Controlled Trial of Levodopa in Combination With Speech-Language Therapy

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 (i.e. difficulty with the comprehension and expression of spoken and written language) following a stroke.

Detailed Summary:

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.

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Sponsor: Rehabilitation Institute of Chicago

Current Primary Outcome: Language Quotient (LQ) on the Western Aphasia Battery [ Time Frame: Change from Baseline in Western Aphasia Battery LQ at 6 weeks ]

Original Primary Outcome: Aphasia Quotient (AQ) on the Western Aphasia Battery [ Time Frame: Change from Baseline in Western Aphasia Battery AQ at 6 weeks ]

Current Secondary Outcome:

• Functional Communication Skills [ Time Frame: Change from Baseline in functional communication skills at 6 weeks ]
  Scores derived from language sample analyses
• Participation in Everyday Activities [ Time Frame: Change from Baseline in participation in everyday activities at 6 weeks ]
  Measures on CETI, QCL,BOSS, CCRSA.
• Western Aphasia Battery - Reading and Writing Scores [ Time Frame: Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks ]
• Western Aphasia Battery Aphasia Quotient (Maintenance) [ Time Frame: Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks ]
• Western Aphasia Battery Reading and Writing Scores (Maintenance) [ Time Frame: Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks ]
• Functional Communication Skills (Maintenance) [ Time Frame: Change in functional communication skills from 6 weeks to 12 weeks ]
• Participation in Everyday Activities (Maintenance) [ Time Frame: Change in participation in everyday activities from 6 weeks to 12 weeks ]

Original Secondary Outcome: Same as current

Information By: Rehabilitation Institute of Chicago

Dates:
Date Received: August 2, 2011
Date Started: October 2007
Date Completion:
Last Updated: November 27, 2013
Last Verified: November 2013