Back to resultsDopaminergic Enhancement of Learning and Memory in Aphasia
Primary Purpose
Cerebrovascular Accident, Aphasia
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
levodopa
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring language acquisition, plasticity, stroke recovery, aphasia treatment, naming, levodopa, stroke
Eligibility 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
Sites / Locations
- Dept. of Neurology, University Hospital Muenster
Outcomes
Primary Outcome Measures
Boost in naming performance (percent correct) through levodopa as compared to placebo
Brain activity pattern in successfully trained patients
Secondary Outcome Measures
Stability of naming performance after one month and six months post treatment
Full Information
NCT ID
NCT00102869
First Posted
February 3, 2005
Last Updated
October 4, 2013
Sponsor
University Hospital Muenster
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT00102869
Brief Title
Dopaminergic Enhancement of Learning and Memory in Aphasia
Official Title
Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Aphasia)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Muenster
Collaborators
German Federal Ministry of Education and Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident, Aphasia
Keywords
language acquisition, plasticity, stroke recovery, aphasia treatment, naming, levodopa, stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
levodopa
Intervention Description
100mg levodopa per day over 10 days/ treatment phase
Primary Outcome Measure Information:
Title
Boost in naming performance (percent correct) through levodopa as compared to placebo
Time Frame
immediately after each treatmentphase
Title
Brain activity pattern in successfully trained patients
Time Frame
immediately after each treatmentphase
Secondary Outcome Measure Information:
Title
Stability of naming performance after one month and six months post treatment
Time Frame
from 1 month untill 6 months after treatment completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caterina Breitenstein, PhD
Organizational Affiliation
Dept. of Neurology, University Hospital Muenster, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stefan Knecht, MD
Organizational Affiliation
Dept. of Neurology, University Hospital Muenster, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. of Neurology, University Hospital Muenster
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48129
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
15236398
Citation
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.
Results Reference
background
PubMed Identifier
15114342
Citation
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.
Results Reference
background
PubMed Identifier
12596014
Citation
Breitenstein C, Knecht S. [Language acquisition and statistical learning]. Nervenarzt. 2003 Feb;74(2):133-43. doi: 10.1007/s00115-002-1466-1. German.
Results Reference
background
PubMed Identifier
25588456
Citation
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.
Results Reference
derived
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Dopaminergic Enhancement of Learning and Memory in Aphasia
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