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Dopaminergic Enhancement of Learning and Memory in Aphasia

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00102869
Enrollment
12
Registered
2005-02-04
Start date
2005-01-31
Completion date
2008-12-31
Last updated
2013-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphasia, Cerebrovascular Accident

Keywords

language acquisition, plasticity, stroke recovery, aphasia treatment, naming, levodopa, stroke

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.

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.

Interventions

DRUGlevodopa

100mg levodopa per day over 10 days/ treatment phase

Sponsors

German Federal Ministry of Education and Research
CollaboratorOTHER_GOV
University Hospital Muenster
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
Boost in naming performance (percent correct) through levodopa as compared to placeboimmediately after each treatmentphase
Brain activity pattern in successfully trained patientsimmediately after each treatmentphase

Secondary

MeasureTime frame
Stability of naming performance after one month and six months post treatmentfrom 1 month untill 6 months after treatment completion

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026