Neuromodulation and Language Acquisition (Stage Ib)

NCT ID: NCT00102856

Last Updated: 2010-06-24

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2006-06-30

Brief Summary

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

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 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Pramipexole

Intervention Type: DRUG

Rivastigmine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Muenster

OTHER

Sponsor Role: lead

Principal Investigators

Caterina Breitenstein, PhD

Role: STUDY_DIRECTOR

Dept. of Neurology, University Hospital Muenster

Stefan Knecht, MD

Role: STUDY_CHAIR

Dept. of Neurology, University Hospital Muenster

Locations

Dept. of Neurology, University Hospital Muenster

Münster, North Rhine-Westphalia, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 15236398 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15114342 (View on PubMed)

Other Identifiers

IZKF Muenster: Kne3/074/04

Identifier Type: -

Identifier Source: secondary_id

KS-NEUROMOD_01, Stage Ib

Identifier Type: -

Identifier Source: org_study_id