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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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The purpose of this study is to determine whether levodopa, in combination with a high frequency language training, is effective in boosting naming performance in patients with aphasia.
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 daily administration of levodopa, coupled with several hours of language training every day, will significantly improve naming abilities in patients with aphasia as compared to placebo administration. We furthermore examine with magnetic resonance imaging which brain regions need to be functionally intact for a dopaminergic improvement of language therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levodopa | Drug | 100mg levodopa per day over 10 days/ treatment phase |
| Measure | Description | Time Frame |
|---|---|---|
| Boost in naming performance (percent correct) through levodopa as compared to placebo | immediately after each treatmentphase | |
| Brain activity pattern in successfully trained patients | immediately after each treatmentphase |
| Measure | Description | Time Frame |
|---|---|---|
| Stability of naming performance after one month and six months post treatment | from 1 month untill 6 months after treatment completion |
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Inclusion Criteria for patients with aphasia:
Exclusion Criteria for patients and healthy controls:
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| Name | Affiliation | Role |
|---|---|---|
| Caterina Breitenstein, PhD | Dept. of Neurology, University Hospital Muenster, Germany | Study Director |
| Stefan Knecht, MD | Dept. of Neurology, University Hospital Muenster, Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Neurology, University Hospital Muenster | Münster | North Rhine-Westphalia | 48129 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15236398 | Background | 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. | |
| 15114342 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 10, 2013 | |
| Unrelease | Yes | |
| Release | Oct 14, 2013 | |
| Reset | Dec 6, 2013 | |
| Release | Dec 9, 2013 | |
| Reset | Jan 28, 2014 | |
| Release | Jan 29, 2014 | |
| Reset | Mar 18, 2014 | |
| Release | May 20, 2014 | |
| Reset | Jun 4, 2014 | |
| Release | Sep 25, 2017 | |
| Reset | Sep 27, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 10, 2013 | Yes | |||
| Oct 14, 2013 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D001037 | Aphasia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007980 | Levodopa |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| 12596014 | Background | Breitenstein C, Knecht S. [Language acquisition and statistical learning]. Nervenarzt. 2003 Feb;74(2):133-43. doi: 10.1007/s00115-002-1466-1. German. |
| 25588456 | Derived | Breitenstein C, Korsukewitz C, Baumgartner A, Floel A, Zwitserlood P, Dobel C, Knecht S. L-dopa does not add to the success of high-intensity language training in aphasia. Restor Neurol Neurosci. 2015;33(2):115-20. doi: 10.3233/RNN-140435. |
| Dec 6, 2013 |
| Dec 9, 2013 | Jan 28, 2014 |
| Jan 29, 2014 | Mar 18, 2014 |
| May 20, 2014 | Jun 4, 2014 |
| Sep 25, 2017 | Sep 27, 2017 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002396 |
| Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |