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Dopaminergic Enhancement of Learning and Memory in Aphasia

NCT ID: NCT00102869

Last Updated: 2013-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebrovascular Accident Aphasia

Keywords

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language acquisition plasticity stroke recovery aphasia treatment naming levodopa stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Interventions

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levodopa

100mg levodopa per day over 10 days/ treatment phase

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Bundesministerium für Bildung und Forschung (BMBF)

Principal Investigators

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Caterina Breitenstein, PhD

Role: STUDY_DIRECTOR

Dept. of Neurology, University Hospital Muenster, Germany

Stefan Knecht, MD

Role: STUDY_CHAIR

Dept. of Neurology, University Hospital Muenster, Germany

Locations

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Dept. of Neurology, University Hospital Muenster

Münster, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 15236398 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15114342 (View on PubMed)

Breitenstein C, Knecht S. [Language acquisition and statistical learning]. Nervenarzt. 2003 Feb;74(2):133-43. doi: 10.1007/s00115-002-1466-1. German.

Reference Type BACKGROUND
PMID: 12596014 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25588456 (View on PubMed)

Other Identifiers

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LL_001, Project on aphasia

Identifier Type: -

Identifier Source: org_study_id