Neuromodulation and Language Acquisition (Project Stage Ia)
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Purpose
The purpose of this study is to determine whether levodopa, pergolid, rivastigmine, or modafinil are effective in boosting semantic language acquisition in healthy subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: levodopa Drug: rivastigmine Drug: pergolid Drug: modafinil |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Improved Language Acquisition Through Neuromodulation, Project Stage Ia |
- Boost in language learning success through neuromodulation
- Stability of language learning success
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | April 2005 |
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.
Eligibility| Ages Eligible for Study: | 20 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Germany | |
| Dept. of Neurology, University Hospital Muenster | |
| Muenster, Nordrhein-Westfalen, Germany, 48129 | |
| Study Director: | Caterina Breitenstein, PhD | Dept. of Neurology, University Hospital Muenster |
| Study Chair: | Stefan Knecht, MD | Dept. of Neurology, University Hospital Muenster |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00102284 History of Changes |
| Other Study ID Numbers: | KS-NEUROMOD_01, Stage Ia, IZKF Muenster: Kne3/074/04 |
| Study First Received: | January 26, 2005 |
| Last Updated: | January 26, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University Hospital Muenster:
|
language acquisition plasticity stroke recovery associative learning |
Additional relevant MeSH terms:
|
Levodopa Modafinil Rivastigmine Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Central Nervous System Stimulants Neuroprotective Agents Protective Agents Cholinesterase Inhibitors Enzyme Inhibitors Cholinergic Agents |
ClinicalTrials.gov processed this record on June 18, 2013