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NCT00102284 Clinical Trial

Neuromodulation and Language Acquisition (Project Stage Ia)

Healthy Clinical Trial

Official title:
Improved Language Acquisition Through Neuromodulation, Project Stage Ia

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00102284
Other study ID # KS-NEUROMOD_01, Stage Ia
Secondary ID IZKF Muenster: K
Status Terminated
Phase Phase 4
First received January 26, 2005
Last updated January 26, 2010
Start date March 2004
Est. completion date April 2005

Study information
Verified date September 2006
Source University Hospital Muenster
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether levodopa, pergolid, rivastigmine, or modafinil are effective in boosting semantic language acquisition in healthy subjects.

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 a mixed d1/d2 dopamine agonist (pergolid) or cholinergic neuromodulation (rivastigmine) or a general centrally arousing substance (modafinil) will yield a learning enhancement comparable to using levodopa in healthy subjects.

Our results show that the dopamine agonist pergolide impaired learning in healthy subjects compared to placebo, whereas cholinergic neuromodulation had no effect.

Recruitment information / eligibility
Status Terminated
Enrollment 100
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria:

- Healthy subjects

- 20-35 years old

- Right handedness

- Left language dominance (as assessed by functional transcranial Doppler ultrasonography [fTCD])

Exclusion Criteria:

- Neurological/psychiatric/metabolic/cardiac disorders

- Asthma

- Known allergic reactions to one of the experimental drugs

- Other drugs affecting the central nervous system

- Leisure drug ingestion during the past 4 weeks (urine test)

- Smoking cessation during the past 2 weeks

- > 6 cups of coffee or energy drinks per day

- > 10 cigarettes per day

- > 50 grams of alcohol per day

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• levodopa

• rivastigmine

• pergolid

• modafinil

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

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Breitenstein C, Flöel A, Korsukewitz C, Wailke S, Bushuven S, Knecht S. A shift of paradigm: from noradrenergic to dopaminergic modulation of learning? J Neurol Sci. 2006 Oct 25;248(1-2):42-7. Epub 2006 Jul 11. — View Citation

Breitenstein C, Korsukewitz C, Flöel A, Kretzschmar T, Diederich K, Knecht S. Tonic dopaminergic stimulation impairs associative learning in healthy subjects. Neuropsychopharmacology. 2006 Nov;31(11):2552-64. Epub 2006 Jul 26. — 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

Korsukewitz C, Breitenstein C, Schomacher M, Knecht S. [Present status and future possibilities of adjuvant pharmacotherapy for aphasia]. Nervenarzt. 2006 Apr;77(4):403-15. Review. German. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Boost in language learning success through neuromodulation
Secondary Stability of language learning success
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