Augmenting Language Therapy for Aphasia: Levodopa

Shirley Ryan AbilityLab

Status and phase: Completed; Phase 3; Phase 2

Conditions: Nonfluent Aphasia; Stroke

Treatments: Drug: levodopa/carbidopa; Drug: Placebo comparator

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01429077

H133G070074

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Levodopa/carbidopa

Active Comparator group

Description:

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.

Treatment:

Drug: levodopa/carbidopa

Inactive pill

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo comparator