Dopaminergic Enhancement of Learning and Memory in Aphasia

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Cerebrovascular Accident; Aphasia	Drug: levodopa	Phase 4

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	12 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Aphasia)
Study Start Date :	January 2005
Actual Primary Completion Date :	February 2007
Actual Study Completion Date :	December 2008

Arms and Interventions

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Intervention Details:

Drug: levodopa
100mg levodopa per day over 10 days/ treatment phase

Outcome Measures

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Primary Outcome Measures :

1. Boost in naming performance (percent correct) through levodopa as compared to placebo [ Time Frame: immediately after each treatmentphase ]
2. Brain activity pattern in successfully trained patients [ Time Frame: immediately after each treatmentphase ]

Secondary Outcome Measures :

1. Stability of naming performance after one month and six months post treatment [ Time Frame: from 1 month untill 6 months after treatment completion ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

University Hospital Muenster

German Federal Ministry of Education and Research

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Homepage of Dr. Breitenstein 

Publications:

Knecht S, Breitenstein C, Bushuven S, Wailke S, Kamping S, Flöel A, Zwitserlood P, Ringelstein EB. Levodopa: faster and better word learning in normal humans. Ann Neurol. 2004 Jul;56(1):20-6.

Breitenstein C, Wailke S, Bushuven S, Kamping S, Zwitserlood P, Ringelstein EB, Knecht S. D-amphetamine boosts language learning independent of its cardiovascular and motor arousing effects. Neuropsychopharmacology. 2004 Sep;29(9):1704-14.

Breitenstein C, Knecht S. [Language acquisition and statistical learning]. Nervenarzt. 2003 Feb;74(2):133-43. Review. German.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Breitenstein C, Korsukewitz C, Baumgärtner A, Flöel A, Zwitserlood P, Dobel C, Knecht S. L-dopa does not add to the success of high-intensity language training in aphasia. Restor Neurol Neurosci. 2015;33(2):115-20. doi: 10.3233/RNN-140435.

Responsible Party:	Rainer Girgenrath, Bundesministerium für Bildung und Forschung (BMBF)
ClinicalTrials.gov Identifier:	NCT00102869 History of Changes
Other Study ID Numbers:	LL_001, Project on aphasia
First Posted:	February 4, 2005
Last Update Posted:	October 7, 2013
Last Verified:	June 2008

Keywords provided by University Hospital Muenster:

language acquisition; plasticity; stroke recovery; aphasia treatment	naming; levodopa; stroke

Additional relevant MeSH terms:

Aphasia; Stroke; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases	Levodopa; Dopamine; Dopamine Agents; Dopamine Agonists; Antiparkinson Agents; Anti-Dyskinesia Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Cardiotonic Agents; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents