Neuromodulation and Language Acquisition (Stage Ib)

June 23, 2010 updated by: University Hospital Muenster

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

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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Muenster, Nordrhein-Westfalen, Germany, 48129
        • Dept. of Neurology, University Hospital Muenster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Boost in language learning success (percent hits) through neuromodulation

Secondary Outcome Measures

Outcome Measure
Stability of language learning success after one week, one month, and one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

February 3, 2005

First Submitted That Met QC Criteria

February 3, 2005

First Posted (ESTIMATE)

February 4, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2010

Last Update Submitted That Met QC Criteria

June 23, 2010

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS-NEUROMOD_01, Stage Ib
  • IZKF Muenster: Kne3/074/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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