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Completed

NCT Number: NCT00102869

Dopaminergic Enhancement of Learning and Memory in 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dept. of Neurology, University Hospital Muenster

Münster, North Rhine-Westphalia, 48129, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

levodopa

Drug

100mg levodopa per day over 10 days/ treatment phase

Primary outcomes

  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 outcomes

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

    Time frame: from 1 month untill 6 months after treatment completion

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Feb 4, 2005
Registry last updated
Oct 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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