Clinical trial NCT00102869: Dopaminergic Enhancement of Learning and Memory in Aphasia
Official title: Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Aphasia)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebrovascular Accident
Aphasia
Keywords: language acquisition
plasticity
stroke recovery
aphasia treatment
naming
levodopa
stroke
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2005-02-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Boost in naming performance (percent correct) through levodopa as compared to placebo
timeFrame: immediately after each treatmentphase
measure: Brain activity pattern in successfully trained patients
timeFrame: immediately after each treatmentphase
Secondary outcomes:
measure: Stability of naming performance after one month and six months post treatment
timeFrame: from 1 month untill 6 months after treatment completion
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Dept. of Neurology, University Hospital Muenster
state: Nordrhein-Westfalen
Study officials:
affiliation: Dept. of Neurology, University Hospital Muenster, Germany
name: Caterina Breitenstein, PhD
role: STUDY_DIRECTOR
affiliation: Dept. of Neurology, University Hospital Muenster, Germany
name: Stefan Knecht, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.