Augmenting Language Therapy for Aphasia: Levodopa

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Leora Cherney, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT01429077
First received: August 2, 2011
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Nonfluent Aphasia
Stroke
Drug: levodopa/carbidopa
Drug: Placebo comparator
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Augmenting Language Therapy for Aphasia: A Randomized Double-Blind Placebo-Controlled Trial of Levodopa in Combination With Speech-Language Therapy

Resource links provided by NLM:


Further study details as provided by Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • Language Quotient (LQ) on the Western Aphasia Battery [ Time Frame: Change from Baseline in Western Aphasia Battery LQ at 6 weeks ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Functional Communication Skills [ Time Frame: Change from Baseline in functional communication skills at 6 weeks ] [ Designated as safety issue: No ]
    Scores derived from language sample analyses

  • Participation in Everyday Activities [ Time Frame: Change from Baseline in participation in everyday activities at 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Western Aphasia Battery Aphasia Quotient (Maintenance) [ Time Frame: Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks ] [ Designated as safety issue: No ]
  • Western Aphasia Battery Reading and Writing Scores (Maintenance) [ Time Frame: Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks ] [ Designated as safety issue: No ]
  • Functional Communication Skills (Maintenance) [ Time Frame: Change in functional communication skills from 6 weeks to 12 weeks ] [ Designated as safety issue: No ]
  • Participation in Everyday Activities (Maintenance) [ Time Frame: Change in participation in everyday activities from 6 weeks to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: October 2007
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Levodopa/carbidopa
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.
Drug: levodopa/carbidopa
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.
Other Name: Sinemet
Placebo Comparator: Inactive pill
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.
Drug: 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.

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429077

Locations
United States, Illinois
Center for Aphasia Research & Treatment
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Rehabilitation Institute of Chicago
U.S. Department of Education
  More Information

No publications provided

Responsible Party: Leora Cherney, Principal Investigator, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT01429077     History of Changes
Other Study ID Numbers: H133G070074
Study First Received: August 2, 2011
Results First Received: June 5, 2013
Last Updated: November 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rehabilitation Institute of Chicago:
Levodopa
Ischemic Stroke
Aphasia
Speech Rehabilitation

Additional relevant MeSH terms:
Aphasia
Aphasia, Broca
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Carbidopa
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014