NCT00102284

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_4 healthy

Timeline
Completed

Started Mar 2004

Typical duration for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

January 27, 2010

Status Verified

September 1, 2006

First QC Date

January 26, 2005

Last Update Submit

January 26, 2010

Conditions

Healthy

Keywords

language acquisitionplasticitystroke recoveryassociative learning

Outcome Measures

Primary Outcomes (1)

  • Boost in language learning success through neuromodulation

Secondary Outcomes (1)

  • Stability of language learning success

Interventions

levodopaDRUG
rivastigmineDRUG
pergolidDRUG
modafinilDRUG

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Neurology, University Hospital Muenster

Münster, North Rhine-Westphalia, 48129, Germany

Location

Related Publications (5)

  • 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.

    PMID: 15236398BACKGROUND

  • 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.

    PMID: 15114342BACKGROUND

  • 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.

    PMID: 16815467BACKGROUND

  • 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.

    PMID: 16273340BACKGROUND

  • 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.

    PMID: 16880771RESULT

MeSH Terms

Interventions

LevodopaRivastigmineModafinil

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosinePhenylcarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsBenzhydryl Compounds

Study Officials

  • Caterina Breitenstein, PhD

    Dept. of Neurology, University Hospital Muenster

    STUDY DIRECTOR

  • Stefan Knecht, MD

    Dept. of Neurology, University Hospital Muenster

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2005

First Posted

January 27, 2005

Study Start

March 1, 2004

Study Completion

April 1, 2005

Last Updated

January 27, 2010

Record last verified: 2006-09

Locations

DE(1)