Clinical trial NCT01429077: Augmenting Language Therapy for Aphasia: Levodopa
Official title: Augmenting Language Therapy for Aphasia: A Randomized Double-Blind Placebo-Controlled Trial of Levodopa in Combination With Speech-Language Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Nonfluent Aphasia
Stroke
Keywords: Levodopa
Ischemic Stroke
Aphasia
Speech Rehabilitation
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2011-09-05
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Language Quotient (LQ) on the Western Aphasia Battery
timeFrame: Change from Baseline in Western Aphasia Battery LQ at 6 weeks
Secondary outcomes:
measure: Functional Communication Skills
timeFrame: Change from Baseline in functional communication skills at 6 weeks
measure: Participation in Everyday Activities
timeFrame: Change from Baseline in participation in everyday activities at 6 weeks
measure: Western Aphasia Battery - Reading and Writing Scores
timeFrame: Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks
measure: Western Aphasia Battery Aphasia Quotient (Maintenance)
timeFrame: Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks
measure: Western Aphasia Battery Reading and Writing Scores (Maintenance)
timeFrame: Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks
measure: Functional Communication Skills (Maintenance)
timeFrame: Change in functional communication skills from 6 weeks to 12 weeks
measure: Participation in Everyday Activities (Maintenance)
timeFrame: Change in participation in everyday activities from 6 weeks to 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Center for Aphasia Research & Treatment
state: Illinois
Study officials:
References: