The purpose of this study is to determine whether levodopa, pergolid, rivastigmine, or modafinil are effective in boosting semantic language acquisition in healthy subjects...
Date First Received: January 26, 2005
Last Updated: September 7, 2006
Verified by: University Hospital Muenster, September 2006
Clinical Trial Phase: Phase 4 | Start Date: March 2004
Overall Status: Terminated
Estimated Enrollment: 100
Brief Summary
Official Title: “Improved Language Acquisition Through Neuromodulation, Project Stage Ia”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to determine whether levodopa, pergolid, rivastigmine, or modafinil are effective in boosting semantic language acquisition in healthy subjects.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: levodopa
- Drug: rivastigmine
- Drug: pergolid
- Drug: modafinil
Outcome Measures for this Clinical Trial
Primary Measures
- Boost in language learning success through neuromodulation
Secondary Measures
- Stability of language learning success
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: 35 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: University Hospital Muenster
Overall Clinical Trial Officials and Contacts
Caterina Breitenstein, PhD Study Director Dept. of Neurology, University Hospital Muenster
Related Publications
References
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.
Citations Reporting Results
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]
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00102284
Study ID Number: KS-NEUROMOD_01, Stage Ia
ClinicalTrials.gov Identifier: NCT00102284
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Clinical Trials Authorship and Review
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