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Dopaminergic Enhancement of Learning and Memory in Aphasia
This study has been completed.
Sponsor:
University Hospital Muenster
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00102869
First received: February 3, 2005
Last updated: October 4, 2013
Last verified: June 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Cerebrovascular Accident Aphasia | Drug: levodopa | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Aphasia) |
Resource links provided by NLM:
Further study details as provided by University Hospital Muenster:
Primary Outcome Measures:
- Boost in naming performance (percent correct) through levodopa as compared to placebo [ Time Frame: immediately after each treatmentphase ]
- Brain activity pattern in successfully trained patients [ Time Frame: immediately after each treatmentphase ]
Secondary Outcome Measures:
- Stability of naming performance after one month and six months post treatment [ Time Frame: from 1 month untill 6 months after treatment completion ]
| Enrollment: | 12 |
| Study Start Date: | January 2005 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: levodopa
100mg levodopa per day over 10 days/ treatment phase
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria for patients with aphasia:
- Unilateral cerebrovascular accident (stroke) in the territory of the arteria media
- Time post onset: > 6 months
- Aphasia with anomia
- Age between 18-75 years
- Premorbid right-handedness
- Primary language: German
Exclusion Criteria for patients and healthy controls:
- Known allergy to levodopa or tartrazine
- History of medication/drug abuse
- Acute nicotine withdrawal or > 15 cigarettes per day
- > 6 cups/glasses of coffee, caffeine drinks or energy drinks per day
- > 50 grams of alcohol per day
- Severe hypertonia (systole >180 mm Hg)
- Severe arteriosclerosis
- Diabetes, asthma, or glaucoma
- Severe hearing disability
- Evidence for severe hippocampal damage
- Premorbid depression or psychosis
- Medication with dopamine agonists or antagonists
- Parkinsonian symptoms
- Changes in anticonvulsive medication during the week prior to study enrollment
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00102869
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102869
Locations
| Germany | |
| Dept. of Neurology, University Hospital Muenster | |
| Muenster, Nordrhein-Westfalen, Germany, 48129 | |
Sponsors and Collaborators
University Hospital Muenster
German Federal Ministry of Education and Research
Investigators
| Study Director: | Caterina Breitenstein, PhD | Dept. of Neurology, University Hospital Muenster, Germany |
| Study Chair: | Stefan Knecht, MD | Dept. of Neurology, University Hospital Muenster, Germany |
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rainer Girgenrath, Bundesministerium für Bildung und Forschung (BMBF) |
| ClinicalTrials.gov Identifier: | NCT00102869 History of Changes |
| Other Study ID Numbers: |
LL_001, Project on aphasia |
| Study First Received: | February 3, 2005 |
| Last Updated: | October 4, 2013 |
Keywords provided by University Hospital Muenster:
|
language acquisition plasticity stroke recovery aphasia treatment |
naming levodopa stroke |
Additional relevant MeSH terms:
|
Aphasia Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms |
Levodopa Dopamine Dopamine Agents Dopamine Agonists Antiparkinson Agents Anti-Dyskinesia Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiotonic Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Protective Agents |
ClinicalTrials.gov processed this record on September 19, 2017