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

August 11, 2008
March 5, 2010
July 2008
March 2010   (final data collection date for primary outcome measure)
Defining the neurophysiological conditions that are necessary for conscious experience. [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00734006 on ClinicalTrials.gov Archive Site
Understanding the neurophysiological correlates of conditions associated with restricted conscious experience such as sedation and anesthesia. [ Time Frame: Immediate ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Cortico-cortical Connectivity During Midazolam Sedation in Humans; a TMS/EEG Study
Cortico-cortical Connectivity During Midazolam Sedation in Humans; a TMS/EEG Study

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Healthy
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Male
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00734006
2008-0018
Yes
Robert Pearce, MD, PhD, University of Wisconsin School of Medicine and Public Health
University of Wisconsin, Madison
Not Provided
Principal Investigator: Robert Pearce, MD, PhD University of Wisconsin, Madison
University of Wisconsin, Madison
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP