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TerminatedNCT00102284Updated Jan 27, 2010

Neuromodulation and Language Acquisition (Project Stage Ia)

A Phase 4 interventional study of levodopa and rivastigmine in Healthy, sponsored by University Hospital Muenster. Terminated at 1 site in Germany. Open to participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-01-27.

Sponsored by University Hospital Muenster · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
All
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Study summary

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

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • language acquisition
  • plasticity
  • stroke recovery
  • associative learning
03

In context

Lead sponsor

University Hospital Muenster is the lead sponsor of 189 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
100 participants

Interventions

  • Druglevodopa
  • Drugrivastigmine
  • Drugpergolid
  • Drugmodafinil
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What researchers measure

Primary outcomes

  1. Boost in language learning success through neuromodulation

Secondary outcomes

  1. Stability of language learning success

07

Study locations

1 site
  • Dept. of Neurology, University Hospital Muenster
    Muenster, Nordrhein-Westfalen 48129, Germany
08

References and documents

Publications

  • Knecht S, Breitenstein C, Bushuven S, Wailke S, Kamping S, Floel A, Zwitserlood P, Ringelstein EB. Levodopa: faster and better word learning in normal humans. Ann Neurol. 2004 Jul;56(1):20-6. doi: 10.1002/ana.20125. PubMed 15236398 ↗
  • Breitenstein C, Wailke S, Bushuven S, Kamping S, Zwitserlood P, Ringelstein EB, Knecht S. D-amphetamine boosts language learning independent of its cardiovascular and motor arousing effects. Neuropsychopharmacology. 2004 Sep;29(9):1704-14. doi: 10.1038/sj.npp.1300464. PubMed 15114342 ↗
  • Breitenstein C, Floel A, Korsukewitz C, Wailke S, Bushuven S, Knecht S. A shift of paradigm: from noradrenergic to dopaminergic modulation of learning? J Neurol Sci. 2006 Oct 25;248(1-2):42-7. doi: 10.1016/j.jns.2006.05.012. Epub 2006 Jul 11. PubMed 16815467 ↗
  • Korsukewitz C, Breitenstein C, Schomacher M, Knecht S. [Present status and future possibilities of adjuvant pharmacotherapy for aphasia]. Nervenarzt. 2006 Apr;77(4):403-15. doi: 10.1007/s00115-005-2006-6. German. PubMed 16273340 ↗
  • Breitenstein C, Korsukewitz C, Floel A, Kretzschmar T, Diederich K, Knecht S. Tonic dopaminergic stimulation impairs associative learning in healthy subjects. Neuropsychopharmacology. 2006 Nov;31(11):2552-64. doi: 10.1038/sj.npp.1301167. Epub 2006 Jul 26. PubMed 16880771 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00102284
Lead sponsor
University Hospital Muenster
First posted
Jan 27, 2005
Start date
Mar 2004
Completion
Apr 2005
Last update
Jan 27, 2010

Study contacts

Caterina Breitenstein, PhD
study director · Dept. of Neurology, University Hospital Muenster
Stefan Knecht, MD
study chair · Dept. of Neurology, University Hospital Muenster
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.

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