Neuromodulation and Language Acquisition (Stage Ib)
The purpose of this study is to determine whether rivastigmine or pramipexol are effective in boosting semantic language acquisition in healthy subjects...
Brief Summary
Official Title: “Neuromodulation and Language Acquisition (KS-Neuromod_01, Stage Ib)”
The purpose of this study is to determine whether rivastigmine or pramipexol are effective in boosting semantic language acquisition in healthy subjects.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 selective d2/d3 dopamine agonist (pramipexole) or cholinergic neuromodulation (rivastigmine), after a titration period of five days, will yield a learning enhancement comparable to using levodopa in healthy subjects. The expected scientific results will strengthen the basis for transferring neuromodulatory interventions from the laboratory to stroke patients with language dysfunctions.
Intervention(s) in this Clinical Trial
- Drug: Pramipexole
- Drug: Rivastigmine
Outcome Measures for this Clinical Trial
Primary Measures
- Boost in language learning success (percent hits) through neuromodulation
Secondary Measures
- Stability of language learning success after one week, one month, and one year
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 Investigator Information
Lead Investigator: University Hospital Muenster Other
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.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00102856
Study ID Number: KS-NEUROMOD_01, Stage Ib
ClinicalTrials.gov Identifier: NCT00102856
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00102856
