Improved Language Acquisition With Levodopa

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by University Hospital Muenster.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00103805
First received: February 14, 2005
Last updated: September 7, 2006
Last verified: September 2006
  Purpose

The purpose of this study is to determine whether the non-daily administration of levodopa is effective in boosting semantic language acquisition in healthy subjects.


Condition Intervention Phase
Healthy
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: Improved Language Acquisition With Levodopa

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Boost in language learning success through levodopa compared to placebo

Secondary Outcome Measures:
  • Stability of language learning success after one month

Estimated Enrollment: 20
Study Start Date: March 2003
Estimated Study Completion Date: December 2003
Detailed Description:

Our prior work using a between-subject design shows that daily administration of d-amphetamine or the dopamine precursor levodopa over the course of five days markedly improves word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind clinical trial, we probe whether the effect can be replicated using a within-subject design, with administration of levodopa and placebo on alternate days for a total period of 10 days.

The expected scientific results will strengthen the basis for transferring neuromodulatory interventions from the laboratory to stroke patients with language dysfunctions. Because of the heterogeneity of stroke patients, only a within-subject design can be used to probe the effects of pharmacological adjuncts to language therapy.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects
  • 20-35 years old
  • Right handedness

Exclusion Criteria:

  • Neurological/psychiatric/metabolic/cardiac disorders
  • Asthma
  • Known allergic reactions to one of the experimental drugs
  • Other drugs affecting the central nervous system
  • Leisure drug ingestion during the past 4 weeks (urine test)
  • Smoking cessation during the past 2 weeks
  • > 6 cups of coffee or energy drinks per day
  • > 10 cigarettes per day
  • > 50 grams of alcohol per day
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103805

Locations
Germany
Dept. of Neurology, University Hospital Muenster
Muenster, Nordrhein-Westfalen, Germany, 48129
Sponsors and Collaborators
University Hospital Muenster
Investigators
Study Director: Caterina Breitenstein, PhD Dept. of Neurology, University of Muenster, Germany
Study Chair: Stefan Knecht, MD Dept. of Neurology, University of Muenster, Germany
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00103805     History of Changes
Other Study ID Numbers: KS-LD_01
Study First Received: February 14, 2005
Last Updated: September 7, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
language acquisition
plasticity
stroke recovery
associative learning

Additional relevant MeSH terms:
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014