Neuromodulation and Language Acquisition (Project Stage Ia) - Full Text View

Sponsor:	University Hospital Muenster
Information provided by:	University Hospital Muenster
ClinicalTrials.gov Identifier:	NCT00102284

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: levodopa Drug: rivastigmine Drug: pergolid Drug: modafinil	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Improved Language Acquisition Through Neuromodulation, Project Stage Ia

Resource links provided by NLM:

Drug Information available for: Levodopa Modafinil Rivastigmine SDZ-ENA 713

U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:

Boost in language learning success through neuromodulation

Secondary Outcome Measures:

Stability of language learning success

Estimated Enrollment:	100
Study Start Date:	March 2004
Estimated Study Completion Date:	April 2005

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.

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: NCT00102284

Locations

Germany, Nordrhein-Westfalen
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:

Breitenstein C, Korsukewitz C, Floel A, Kretzschmar T, Diederich K, Knecht S. Tonic Dopaminergic Stimulation Impairs Associative Learning in Healthy Subjects. Neuropsychopharmacology. 2006 Jul 26; [Epub ahead of print]

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.

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.

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 Jun 29; [Epub ahead of print]

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. German.

Study ID Numbers:	KS-NEUROMOD_01, Stage Ia, IZKF Muenster: Kne3/074/04
Study First Received:	January 26, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00102284 History of Changes
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:

Neurotransmitter Agents
Rivastigmine
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Stimulants
Enzyme Inhibitors
Cholinergic Agents

Neuroprotective Agents
Protective Agents
Modafinil
Pharmacologic Actions
Cholinesterase Inhibitors
Therapeutic Uses
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009