Dopaminergic Enhancement of Learning and Memory in Aphasia

Study Overview
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Brief Summary
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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.

Detailed Description
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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. We furthermore examine with magnetic resonance imaging which brain regions need to be functionally intact for a dopaminergic improvement of language therapy.

Official Title
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Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Aphasia)

Conditions
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Cerebrovascular Accident, Aphasia

Intervention / Treatment
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* Drug: levodopa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for patients with aphasia: 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 for patients and healthy controls: Known allergy to levodopa or tartrazine 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, asthma, or glaucoma Severe hearing disability Evidence for severe hippocampal damage Premorbid depression or psychosis Medication with dopamine agonists or antagonists Parkinsonian symptoms Changes in anticonvulsive medication during the week prior to study enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: levodopa|100mg levodopa per day over 10 days/ treatment phase|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boost in naming performance (percent correct) through levodopa as compared to placebo |  | immediately after each treatmentphase | 
| Brain activity pattern in successfully trained patients |  | immediately after each treatmentphase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability of naming performance after one month and six months post treatment |  | from 1 month untill 6 months after treatment completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plasticity, language acquisition, stroke recovery, aphasia treatment, naming, levodopa, stroke