Neuromodulation and Language Acquisition (Project Stage Ia)

This study has been terminated.
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00102284
First received: January 26, 2005
Last updated: January 26, 2010
Last verified: September 2006
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Improved Language Acquisition Through Neuromodulation, Project Stage Ia

Resource links provided by NLM:


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

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Both
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
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: 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
Study First Received: January 26, 2005
Last Updated: January 26, 2010
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:
Rivastigmine
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014