Dopaminergic Enhancement of Learning and Memory in Aphasia

Cerebrovascular Accident Clinical Trial

Official title:

Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Aphasia)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102869
• Other study ID #: LL_001, Project on aphasia
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2005
• Last updated: October 4, 2013
• Start date: January 2005
• Est. completion date: December 2008

Study information

• Verified date: June 2008
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2008
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Cerebrovascular Accident
• Stroke

Intervention

Drug:
• levodopa
100mg levodopa per day over 10 days/ treatment phase

Locations

Country	Name	City	State
Germany	Dept. of Neurology, University Hospital Muenster	Muenster	Nordrhein-Westfalen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boost in naming performance (percent correct) through levodopa as compared to placebo		immediately after each treatmentphase
Primary	Brain activity pattern in successfully trained patients		immediately after each treatmentphase
Secondary	Stability of naming performance after one month and six months post treatment		from 1 month untill 6 months after treatment completion

External Links

•   Homepage of Dr. Breitenstein