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

History of Changes

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Pramipexole Drug: Rivastigmine	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Neuromodulation and Language Acquisition (KS-Neuromod_01, Stage Ib)

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:

Boost in language learning success (percent hits) through neuromodulation

Secondary Outcome Measures:

Stability of language learning success after one week, one month, and one year


Estimated Enrollment:	60
Study Start Date:	January 2005
Estimated Study Completion Date:	June 2006

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 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.

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102856

Locations


Germany
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:

Knecht S, Breitenstein C, Bushuven S, Wailke S, Kamping S, Flöel 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.


ClinicalTrials.gov Identifier:	NCT00102856 History of Changes
Other Study ID Numbers:	KS-NEUROMOD_01, Stage Ib, IZKF Muenster: Kne3/074/04
Study First Received:	February 3, 2005
Last Updated:	June 23, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:


language acquisition plasticity stroke recovery associative learning

ClinicalTrials.gov processed this record on March 03, 2015

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