Neuromodulation and Language Acquisition (Stage Ib)
This study has suspended participant recruitment.
Sponsor:
University Hospital Muenster
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00102856
First received: February 3, 2005
Last updated: June 23, 2010
Last verified: September 2006
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Purpose
The purpose of this study is to determine whether rivastigmine or pramipexol are effective in boosting semantic language acquisition in healthy subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Pramipexole Drug: Rivastigmine |
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: | Neuromodulation and Language Acquisition (KS-Neuromod_01, Stage Ib) |
Resource links provided by NLM:
Further study details as provided by University Hospital Muenster:
Primary Outcome Measures:
- Boost in language learning success (percent hits) through neuromodulation
Secondary Outcome Measures:
- Stability of language learning success after one week, one month, and one year
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | June 2006 |
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.
Eligibility| Ages Eligible for Study: | 20 Years to 35 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102856
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102856
Locations
| Germany | |
| 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 Hospital Muenster |
| Study Chair: | Stefan Knecht, MD | Dept. of Neurology, University Hospital Muenster |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00102856 History of Changes |
| Other Study ID Numbers: | KS-NEUROMOD_01, Stage Ib IZKF Muenster: Kne3/074/04 |
| Study First Received: | February 3, 2005 |
| Last Updated: | June 23, 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:
|
Pramipexole Rivastigmine Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents |
Dopamine Agonists Dopamine Agents Neurotransmitter Agents Cholinesterase Inhibitors Enzyme Inhibitors Cholinergic Agents Neuroprotective Agents |
ClinicalTrials.gov processed this record on September 30, 2016