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Neuromodulation and Language Acquisition (Stage Ib)

This study has suspended participant recruitment.
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00102856
First received: February 3, 2005
Last updated: June 23, 2010
Last verified: September 2006
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Pramipexole
Drug: Rivastigmine
 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: Neuromodulation and Language Acquisition (KS-Neuromod_01, Stage Ib)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Boost in language learning success (percent hits) through neuromodulation

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

Estimated Enrollment: 60
Study Start Date: January 2005
Estimated Study Completion Date: June 2006
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.

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102856

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:
Homepage of Dr. Breitenstein  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00102856     History of Changes
Other Study ID Numbers: KS-NEUROMOD_01, Stage Ib, IZKF Muenster: Kne3/074/04
Study First Received: February 3, 2005
Last Updated: June 23, 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:
Pramipexol
Rivastigmine
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
 Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on May 23, 2013