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NCT00102856 Clinical Trial

Neuromodulation and Language Acquisition (Stage Ib)

Healthy Clinical Trial

Official title:
Neuromodulation and Language Acquisition (KS-Neuromod_01, Stage Ib)

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT00102856
Other study ID # KS-NEUROMOD_01, Stage Ib
Secondary ID IZKF Muenster: K
Status Suspended
Phase Phase 4
First received February 3, 2005
Last updated June 23, 2010
Start date January 2005
Est. completion date June 2006

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 rivastigmine or pramipexol 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 selective d2/d3 dopamine agonist (pramipexole) or cholinergic neuromodulation (rivastigmine), after a titration period of five days, will yield a learning enhancement comparable to using levodopa in healthy subjects. The expected scientific results will strengthen the basis for transferring neuromodulatory interventions from the laboratory to stroke patients with language dysfunctions.

Recruitment information / eligibility
Status Suspended
Enrollment 60
Est. completion date June 2006
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:
• Pramipexole

• Rivastigmine

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 (2)

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 language learning success (percent hits) through neuromodulation
Secondary Stability of language learning success after one week, one month, and one year
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