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Dopaminergic Enhancement of Learning and Memory in Aphasia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by University Hospital Muenster.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00102869
First received: February 3, 2005
Last updated: April 19, 2007
Last verified: April 2007
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Aphasia)

Resource links provided by NLM:

MedlinePlus related topics: Aphasia Memory
U.S. FDA Resources

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
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

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

Publications:

ClinicalTrials.gov Identifier: NCT00102869     History of Changes
Other Study ID Numbers: LL_001, Project on aphasia
Study First Received: February 3, 2005
Last Updated: April 19, 2007
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

Additional relevant MeSH terms:
Aphasia
Cerebral Infarction
Stroke
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Dopamine
Dopamine Agents
Levodopa
Dopamine Agonists
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 19, 2013