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Neuromodulation and Language Acquisition (Stage Ib)

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ClinicalTrials.gov Identifier: NCT00102856
Recruitment Status : Suspended
First Posted : February 4, 2005
Last Update Posted : June 24, 2010
Sponsor:
Information provided by:
University Hospital Muenster

Study Description
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Brief Summary:
The purpose of this study is to determine whether rivastigmine or pramipexol are effective in boosting semantic language acquisition in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: Pramipexole Drug: Rivastigmine Phase 4

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 selective d2/d3 dopamine agonist (pramipexole) or cholinergic neuromodulation (rivastigmine), after a titration period of five days, will yield a learning enhancement comparable to using levodopa in healthy subjects. The expected scientific results will strengthen the basis for transferring neuromodulatory interventions from the laboratory to stroke patients with language dysfunctions.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Neuromodulation and Language Acquisition (KS-Neuromod_01, Stage Ib)
Study Start Date : January 2005
Study Completion Date : June 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Boost in language learning success (percent hits) through neuromodulation

Secondary Outcome Measures :
  1. Stability of language learning success after one week, one month, and one year

Eligibility Criteria
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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
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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): NCT00102856


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

Publications:

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ClinicalTrials.gov Identifier: NCT00102856    
Other Study ID Numbers: KS-NEUROMOD_01, Stage Ib
IZKF Muenster: Kne3/074/04
First Posted: February 4, 2005    Key Record Dates
Last Update Posted: June 24, 2010
Last Verified: September 2006
Keywords provided by University Hospital Muenster:
language acquisition
plasticity
stroke recovery
associative learning
Additional relevant MeSH terms:
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Pramipexole
Rivastigmine
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
 Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Neuroprotective Agents