Dopaminergic Enhancement of Learning and Memory in Aphasia

October 4, 2013 updated by: University Hospital Muenster

Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Aphasia)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Boost in naming performance (percent correct) through levodopa as compared to placebo
Time Frame: immediately after each treatmentphase
immediately after each treatmentphase
Brain activity pattern in successfully trained patients
Time Frame: immediately after each treatmentphase
immediately after each treatmentphase

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

February 3, 2005

First Submitted That Met QC Criteria

February 3, 2005

First Posted (Estimate)

February 4, 2005

Study Record Updates

Last Update Posted (Estimate)

October 7, 2013

Last Update Submitted That Met QC Criteria

October 4, 2013

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LL_001, Project on aphasia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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