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

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00734006
First received: August 11, 2008
Last updated: March 5, 2010
Last verified: March 2010
History of Changes
  Purpose

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
Healthy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cortico-cortical Connectivity During Midazolam Sedation in Humans; a TMS/EEG Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Defining the neurophysiological conditions that are necessary for conscious experience. [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Understanding the neurophysiological correlates of conditions associated with restricted conscious experience such as sedation and anesthesia. [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: July 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy right-handed men aged 18-35 who do not smoke or have any metallic implants may be eligible for this study.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734006

Locations
United States, Wisconsin
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
  More Information

No publications provided

Responsible Party: Robert Pearce, MD, PhD, University of Wisconsin School of Medicine and Public Health
ClinicalTrials.gov Identifier: NCT00734006     History of Changes
Other Study ID Numbers: 2008-0018
Study First Received: August 11, 2008
Last Updated: March 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Cortico-cortical
connectivity
Transcranial
Magnetic
Stimulation

Additional relevant MeSH terms:
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
 Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013