Improved Language Acquisition With Levodopa

NCT ID: NCT00103805

Last Updated: 2014-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2005-08-31

Brief Summary

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.

Detailed Description

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

levodopa

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Muenster

OTHER

Sponsor Role: lead

Principal Investigators

Caterina Breitenstein, PhD

Role: STUDY_DIRECTOR

Dept. of Neurology, University of Muenster, Germany

Stefan Knecht, MD

Role: STUDY_CHAIR

Dept. of Neurology, University of Muenster, Germany

Locations

Dept. of Neurology, University Hospital Muenster

Münster, North Rhine-Westphalia, Germany

Countries

Germany

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. 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)

Other Identifiers

KS-LD_01

Identifier Type: -

Identifier Source: org_study_id