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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

February 3, 2005
June 23, 2010
January 2005
Not Provided
Boost in language learning success (percent hits) through neuromodulation
Same as current
Complete list of historical versions of study NCT00102856 on ClinicalTrials.gov Archive Site
Stability of language learning success after one week, one month, and one year
Same as current
Not Provided
Not Provided
 
Neuromodulation and Language Acquisition (Stage Ib)
Neuromodulation and Language Acquisition (KS-Neuromod_01, Stage Ib)

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Healthy
  • Drug: Pramipexole
  • Drug: Rivastigmine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
60
June 2006
Not Provided

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
Both
20 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00102856
KS-NEUROMOD_01, Stage Ib, IZKF Muenster: Kne3/074/04
Not Provided
Not Provided
University Hospital Muenster
Not Provided
Study Director: Caterina Breitenstein, PhD Dept. of Neurology, University Hospital Muenster
Study Chair: Stefan Knecht, MD Dept. of Neurology, University Hospital Muenster
University Hospital Muenster
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP