Improved Language Acquisition With Levodopa

Sponsor

University Hospital Muenster (Other)

Overall Status

Completed

CT.gov ID

NCT00103805

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: levodopa	Phase 4

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Improved Language Acquisition With Levodopa

Study Start Date :

Mar 1, 2003

Actual Primary Completion Date :

Aug 1, 2005

Actual Study Completion Date :

Aug 1, 2005

Outcome Measures

Primary Outcome Measures

Boost in language learning success through levodopa compared to placebo []

Secondary Outcome Measures

Stability of language learning success after one month []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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 of Muenster, Germany
Study Chair: Stefan Knecht, MD, Dept. of Neurology, University of Muenster, Germany