Dopaminergic Enhancement of Learning and Memory in Aphasia

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00102869
First received: February 3, 2005
Last updated: October 4, 2013
Last verified: June 2008
  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 (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Aphasia)

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Boost in naming performance (percent correct) through levodopa as compared to placebo [ Time Frame: immediately after each treatmentphase ] [ Designated as safety issue: No ]
  • Brain activity pattern in successfully trained patients [ Time Frame: immediately after each treatmentphase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stability of naming performance after one month and six months post treatment [ Time Frame: from 1 month untill 6 months after treatment completion ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: January 2005
Study Completion Date: December 2008
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: levodopa
    100mg levodopa per day over 10 days/ treatment phase
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
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
Study First Received: February 3, 2005
Last Updated: October 4, 2013
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 July 20, 2014