Neuromodulation and Language Acquisition (Project Stage Ia) - Tabular View

Tracking Information

First Received Date ^ICMJE

January 26, 2005

Last Updated Date

September 7, 2006

Start Date ^ICMJE

March 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Boost in language learning success through neuromodulation

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00102284 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Stability of language learning success

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Neuromodulation and Language Acquisition (Project Stage Ia)

Official Title ^ICMJE

Improved Language Acquisition Through Neuromodulation, Project Stage Ia

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.

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: levodopa
Drug: rivastigmine
Drug: pergolid
Drug: modafinil

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

100

Completion Date

April 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00102284

Responsible Party

Study ID Numbers ^ICMJE

KS-NEUROMOD_01, Stage Ia, IZKF Muenster: Kne3/074/04

Study Sponsor ^ICMJE

University Hospital Muenster

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	Caterina Breitenstein, PhD	Dept. of Neurology, University Hospital Muenster
Study Chair:	Stefan Knecht, MD	Dept. of Neurology, University Hospital Muenster

Information Provided By

University Hospital Muenster

Verification Date

September 2006

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