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CompletedNCT00102869Updated Oct 7, 2013

Dopaminergic Enhancement of Learning and Memory in Aphasia

A Phase 4 interventional study of levodopa in Cerebrovascular Accident and Aphasia, sponsored by University Hospital Muenster. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-07.

Sponsored by University Hospital Muenster · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cerebrovascular Accident
  • Aphasia

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Keywords

  • language acquisition
  • plasticity
  • stroke recovery
  • aphasia treatment
  • naming
  • levodopa
  • stroke
03

In context

Aphasia

365 studies on the registry are indexed under Aphasia; 89 are open to participants now.

This study's enrollment of 12 is below the median of 30 across 316 interventional studies indexed under Aphasia.

Browse Aphasia studies →

Lead sponsor

University Hospital Muenster is the lead sponsor of 189 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Interventions

  • Druglevodopa

    100mg levodopa per day over 10 days/ treatment phase

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What researchers measure

Primary outcomes

  1. Boost in naming performance (percent correct) through levodopa as compared to placebo

    Time frame: immediately after each treatmentphase

  2. Brain activity pattern in successfully trained patients

    Time frame: immediately after each treatmentphase

Secondary outcomes

  1. Stability of naming performance after one month and six months post treatment

    Time frame: from 1 month untill 6 months after treatment completion

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Study locations

1 site
  • Dept. of Neurology, University Hospital Muenster
    Muenster, Nordrhein-Westfalen 48129, Germany
08

References and documents

Publications

  • 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. PubMed 15236398 ↗
  • 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. PubMed 15114342 ↗
  • Breitenstein C, Knecht S. [Language acquisition and statistical learning]. Nervenarzt. 2003 Feb;74(2):133-43. doi: 10.1007/s00115-002-1466-1. German. PubMed 12596014 ↗
  • 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. PubMed 25588456 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00102869
Lead sponsor
University Hospital Muenster
Collaborators
German Federal Ministry of Education and Research
First posted
Feb 4, 2005
Start date
Jan 2005
Primary completion
Feb 2007
Completion
Dec 2008
Last update
Oct 7, 2013

Study contacts

Caterina Breitenstein, PhD
study director · Dept. of Neurology, University Hospital Muenster, Germany
Stefan Knecht, MD
study chair · Dept. of Neurology, University Hospital Muenster, Germany

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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