Neuromodulation and Language Acquisition (Project Stage Ia)

NCT ID: NCT00102284

Last Updated: 2010-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-04-30

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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levodopa

Intervention Type DRUG

rivastigmine

Intervention Type DRUG

pergolid

Intervention Type DRUG

modafinil

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Principal Investigators

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Caterina Breitenstein, PhD

Role: STUDY_DIRECTOR

Dept. of Neurology, University Hospital Muenster

Stefan Knecht, MD

Role: STUDY_CHAIR

Dept. of Neurology, University Hospital Muenster

Locations

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Dept. of Neurology, University Hospital Muenster

Münster, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 15236398 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15114342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16815467 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16273340 (View on PubMed)

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.

Reference Type RESULT
PMID: 16880771 (View on PubMed)

Other Identifiers

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IZKF Muenster: Kne3/074/04

Identifier Type: -

Identifier Source: secondary_id

KS-NEUROMOD_01, Stage Ia

Identifier Type: -

Identifier Source: org_study_id

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