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Cortico-cortical Connectivity During Midazolam Sedation in Humans; a TMS/EEG Study

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT00734006
Collaborator
(none)
20
Enrollment
1
Location
20
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the proposed research is to measure the effect of drug-induced sedation on the functional connectivity between brain regions as indicated by EEG signal transmission within the human brain. The results of this study will help to identify the neurophysiological correlates of changes in conscious experience that occur during drug-induced sedation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In the proposed experiments cortical areas will be stimulated using low frequency, low-amplitude transcranial magnetic stimulation (TMS) in healthy human subjects during wakefulness and during drug-induced responsive sedation and unresponsive sedation. Simultaneously, high-density electroencephalography (Hd-EEG) will be recorded to evaluate the temporal and spatial characteristics of evoked responses and induced rhythms over the cortex.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Cortico-cortical Connectivity During Midazolam Sedation in Humans; a TMS/EEG Study
    Study Start Date :
    Jul 1, 2008
    Actual Primary Completion Date :
    Mar 1, 2010
    Actual Study Completion Date :
    Mar 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. Defining the neurophysiological conditions that are necessary for conscious experience. [Immediate]

    Secondary Outcome Measures

    1. Understanding the neurophysiological correlates of conditions associated with restricted conscious experience such as sedation and anesthesia. [Immediate]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy right-handed men

    • Aged 18-35

    • Non-smokers

    • No metallic implants

    Exclusion Criteria:
    • Younger than 18 or over the age of 35.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792

    Sponsors and Collaborators

    • University of Wisconsin, Madison

    Investigators

    • Principal Investigator: Robert Pearce, MD, PhD, University of Wisconsin, Madison

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT00734006
    Other Study ID Numbers:
    • 2008-0018
    First Posted:
    Aug 13, 2008
    Last Update Posted:
    May 7, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by University of Wisconsin, Madison
    Cortico-cortical
    connectivity
    Transcranial
    Magnetic
    Stimulation

    Study Results

    No Results Posted as of May 7, 2015