Healthy Living |
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Clinical Trial: Improved Language Acquisition with Levodopa
This study is no longer recruiting patients.
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Purpose
The purpose of this study is to determine whether the non-daily administration of levodopa is effective in boosting semantic language acquisition in healthy subjects.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Healthy | Drug: levodopa | Phase IV |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Secondary Outcomes: Stability of language learning success after one month
Expected Total Enrollment: 20
Study start: March 2003; Study completion: June 2005
Last follow-up: December 2003; Data entry closure: January 2004
Our prior work using a between-subject design shows that daily administration of d-amphetamine or the dopamine precursor levodopa over the course of five days markedly improves word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind clinical trial, we probe whether the effect can be replicated using a within-subject design, with administration of levodopa and placebo on alternate days for a total period of 10 days.
The expected scientific results will strengthen the basis for transferring neuromodulatory interventions from the laboratory to stroke patients with language dysfunctions. Because of the heterogeneity of stroke patients, only a within-subject design can be used to probe the effects of pharmacological adjuncts to language therapy.
Eligibility
Ages Eligible for Study: 20 Years - 35 Years, Genders Eligible for Study: Male
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
- Healthy subjects
- 20-35 years old
- Right handedness
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
Location Information
Germany, Nordrhein-Westfalen
Dept. of Neurology, University Hospital Muenster, Muenster, Nordrhein-Westfalen, 48129, Germany
Caterina Breitenstein, PhD, Study Director, Dept. of Neurology, University of Muenster, Germany
Stefan Knecht, MD, Study Chair, Dept. of Neurology, University of Muenster, Germany
More Information
Homepage of Dr. Breitenstein
Publications
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.
Record last reviewed: February 2005
Last Updated: February 15, 2005
Record first received: February 14, 2005
ClinicalTrials.gov Identifier: NCT00103805
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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