NCT00102869

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 7, 2013

Status Verified

June 1, 2008

Enrollment Period

2.1 years

First QC Date

February 3, 2005

Last Update Submit

October 4, 2013

Conditions

Cerebrovascular AccidentAphasia

Keywords

language acquisitionplasticitystroke recoveryaphasia treatmentnaminglevodopastroke

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

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

    from 1 month untill 6 months after treatment completion

Interventions

levodopaDRUG

100mg levodopa per day over 10 days/ treatment phase

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Neurology, University Hospital Muenster

Münster, North Rhine-Westphalia, 48129, Germany

Location

Related Publications (4)

  • 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.

    PMID: 15236398BACKGROUND

  • 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.

    PMID: 15114342BACKGROUND

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

    PMID: 12596014BACKGROUND

  • 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.

    PMID: 25588456DERIVED

MeSH Terms

Conditions

StrokeAphasia

Interventions

Levodopa

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosine

Study Officials

  • Caterina Breitenstein, PhD

    Dept. of Neurology, University Hospital Muenster, Germany

    STUDY DIRECTOR

  • Stefan Knecht, MD

    Dept. of Neurology, University Hospital Muenster, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 3, 2005

First Posted

February 4, 2005

Study Start

January 1, 2005

Primary Completion

February 1, 2007

Study Completion

December 1, 2008

Last Updated

October 7, 2013

Record last verified: 2008-06

Locations

DE(1)