The purpose of this study is to determine whether levodopa, in combination with a high frequency language training, is effective in boosting naming performance in patients with aphasia.

Condition	Treatment or Intervention	Phase
Cerebrovascular Accident Aphasia	Drug: levodopa	Phase IV

Further Study Details: 

Primary Outcomes: Boost in naming performance (percent correct) through levodopa as compared to placebo
Secondary Outcomes: Stability of naming performance after one month post treatment
Expected Total Enrollment:  20

Our prior work shows that d-amphetamine and the dopamine precursor levodopa markedly improve word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind clinical trial, we probe whether daily administration of levodopa, coupled with several hours of language training every day, will significantly improve naming abilities in patients with aphasia as compared to placebo administration.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Unilateral cerebrovascular accident (stroke) in the territory of the arteria media
• Time post onset: > 6 months
• Aphasia with anomia
• Age between 18-75 years
• Premorbid right-handedness
• Primary language: German

Exclusion Criteria:

• Known allergy to levodopa or tatrazine
• History of medication/drug abuse
• Acute nicotine withdrawal or > 15 cigarettes per day
• > 6 cups/glasses of coffee, caffeine drinks or energy drinks per day
• > 50 grams of alcohol per day
• Severe hypertonia (systole >180 mm Hg)
• Severe arteriosclerosis
• Diabetes, astma, or glaucoma
• Severe hearing disability
• Evidence for severe hippocampal damage
• Premorbid depression or psychosis
• Medication with dopamine agonists or antagonists Anhalt
• Parkinsonoid symptoms
• Changes in anticonvulsive medication during the week prior to study enrollment

Marion Schomacher, MA      +49-251-83  Ext. 45304    mschoma@uni-muenster.de
Caterina Breitenstein, PhD      +49-251-83  Ext. 49969    breitens@uni-muenster.de

Germany, Nordrhein-Westfalen
      Dept. of Neurology, University Hospital Muenster, Muenster,  Nordrhein-Westfalen,  48129,  Germany; Recruiting

Study chairs or principal investigators

Caterina Breitenstein, PhD,  Study Director,  Dept. of Neurology, University Hospital Muenster, Germany   
Stefan Knecht, MD,  Study Chair,  Dept. of Neurology, University Hospital Muenster, Germany   

Study ID Numbers:  LL_001, Project on aphasia
Record last reviewed:  February 2005
Last Updated:  February 3, 2005
Record first received:  February 3, 2005
ClinicalTrials.gov Identifier:  NCT00102869
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08