Dopaminergic Enhancement of Learning and Memory in Aphasia

Sponsor

University Hospital Muenster (Other)

Overall Status

Completed

CT.gov ID

NCT00102869

Collaborator

German Federal Ministry of Education and Research (Other)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Accident Aphasia	Drug: levodopa	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

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)

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

Boost in naming performance (percent correct) through levodopa as compared to placebo [immediately after each treatmentphase]
Brain activity pattern in successfully trained patients [immediately after each treatmentphase]

Secondary Outcome Measures

Stability of naming performance after one month and six months post treatment [from 1 month untill 6 months after treatment completion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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