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Dopaminergic Enhancement of Learning and Memory in Aphasia

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ClinicalTrials.gov Identifier: NCT00102869
Recruitment Status : Completed
First Posted : February 4, 2005
Last Update Posted : October 7, 2013
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
University Hospital Muenster

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia Memory
Drug Information available for: Levodopa


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


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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102869


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

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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    Key Record Dates
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