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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00734006
First Posted: August 13, 2008
Last Update Posted: May 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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

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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00734006     History of Changes
Other Study ID Numbers: 2008-0018
First Submitted: August 11, 2008
First Posted: August 13, 2008
Last Update Posted: May 7, 2015
Last Verified: May 2015

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

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