Dopaminergic Enhancement of Learning and Memory in Aphasia - Full Text View

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 Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Aphasia)

Resource links provided by NLM:

MedlinePlus related topics: Aphasia Memory

Drug Information available for: Dopamine Levodopa Dopamine hydrochloride

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
Brain activity pattern in successfully trained patients [ Time Frame: immediately after each treatmentphase ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]


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:

100mg levodopa per day over 10 days/ treatment phase

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


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Homepage of Dr. Breitenstein This link exits the ClinicalTrials.gov site

Publications:

Knecht S, Breitenstein C, Bushuven S, Wailke S, Kamping S, Flöel A, Zwitserlood P, Ringelstein EB. Levodopa: faster and better word learning in normal humans. Ann Neurol. 2004 Jul;56(1):20-6.

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.

Breitenstein C, Knecht S. [Language acquisition and statistical learning]. Nervenarzt. 2003 Feb;74(2):133-43. Review. German.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Breitenstein C, Korsukewitz C, Baumgärtner A, Flöel 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.


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
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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 23, 2016