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Neuromodulation and Language Acquisition (Project Stage Ia)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00102284
First Posted: January 27, 2005
Last Update Posted: January 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Muenster
  Purpose
The purpose of this study is to determine whether levodopa, pergolid, rivastigmine, or modafinil are effective in boosting semantic language acquisition in healthy subjects.

Condition Intervention Phase
Healthy Drug: levodopa Drug: rivastigmine Drug: pergolid Drug: modafinil Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Improved Language Acquisition Through Neuromodulation, Project Stage Ia

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Boost in language learning success through neuromodulation

Secondary Outcome Measures:
  • Stability of language learning success

Estimated Enrollment: 100
Study Start Date: March 2004
Estimated Study Completion Date: April 2005
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 a mixed d1/d2 dopamine agonist (pergolid) or cholinergic neuromodulation (rivastigmine) or a general centrally arousing substance (modafinil) will yield a learning enhancement comparable to using levodopa in healthy subjects.

Our results show that the dopamine agonist pergolide impaired learning in healthy subjects compared to placebo, whereas cholinergic neuromodulation had no effect.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects
  • 20-35 years old
  • Right handedness
  • Left language dominance (as assessed by functional transcranial Doppler ultrasonography [fTCD])

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
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): NCT00102284


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 Hospital Muenster
Study Chair: Stefan Knecht, MD Dept. of Neurology, University Hospital Muenster
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00102284     History of Changes
Other Study ID Numbers: KS-NEUROMOD_01, Stage Ia
IZKF Muenster: Kne3/074/04
First Submitted: January 26, 2005
First Posted: January 27, 2005
Last Update Posted: January 27, 2010
Last Verified: September 2006

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

Additional relevant MeSH terms:
Levodopa
Rivastigmine
Modafinil
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Neuroprotective Agents
Protective Agents