Dopaminergic Enhancement of Learning and Memory in Aphasia - Full Text View

Sponsored by:	University Hospital Muenster
Information provided by:	University Hospital Muenster
ClinicalTrials.gov Identifier:	NCT00102869

Purpose

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	Intervention	Phase
Cerebrovascular Accident Aphasia	Drug: levodopa	Phase IV

MedlinePlus related topics: Aphasia Memory

Drug Information available for: Dopamine Dopamine hydrochloride Levodopa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Aphasia)

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:

Boost in naming performance (percent correct) through levodopa as compared to placebo
Brain activity pattern in successfully trained patients

Secondary Outcome Measures:

Stability of naming performance after one month and six months post treatment

Estimated Enrollment:	10
Study Start Date:	January 2005
Estimated Study Completion Date:	December 2008

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102869

Contacts

Contact: Kira Wedler, MA	+49-251-83 ext 45304	kira.wedler@uni-muenster.de
Contact: Caterina Breitenstein, PhD	+49-251-83 ext 49969	breitens@uni-muenster.de

Locations

Germany, Nordrhein-Westfalen
Dept. of Neurology, University Hospital Muenster	Recruiting
Muenster, Nordrhein-Westfalen, Germany, 48129
Contact: Stefan Knecht, MD +49-251-83 ext 48195 knecht@uni-muenster.de
Contact: Caterina Breitenstein, PhD +49-251-83 ext 49969 breitens@uni-muenster.de
Principal Investigator: Caterina Breitenstein, PhD
Principal Investigator: Stefan Knecht, MD

Sponsors and Collaborators

University Hospital Muenster

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

Homepage of Dr. Breitenstein This link exits the ClinicalTrials.gov site

Publications:

Knecht S, Breitenstein C, Bushuven S, Wailke S, Kamping S, Floel 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.

Study ID Numbers:	LL_001, Project on aphasia
Study First Received:	February 3, 2005
Last Updated:	April 19, 2007
ClinicalTrials.gov Identifier:	NCT00102869
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:

language acquisition
plasticity
stroke recovery
aphasia treatment

naming
levodopa
stroke

Study placed in the following topic categories:

Levodopa
Speech Disorders
Cerebral Infarction
Aphasia
Stroke
Vascular Diseases
Central Nervous System Diseases
Language Disorders
Ischemia
Brain Diseases

Cerebrovascular Disorders
Signs and Symptoms
Dopamine
Neurologic Manifestations
Brain Ischemia
Brain Infarction
Infarction
Neurobehavioral Manifestations
Communication Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases

Antiparkinson Agents
Dopamine Agents
Cardiovascular Diseases
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009