Augmenting Language Therapy for Aphasia: Levodopa

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rehabilitation Institute of Chicago; Shirley Ryan AbilityLab
• Collaborator: U.S. Department of Education
• Treatments: Carbidopa; Levodopa

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.