NCT00734006

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

August 11, 2008

Last Update Submit

May 6, 2015

Conditions

Healthy

Keywords

Cortico-corticalconnectivityTranscranialMagneticStimulation

Outcome Measures

Primary Outcomes (1)

  • Defining the neurophysiological conditions that are necessary for conscious experience.

    Immediate

Secondary Outcomes (1)

  • Understanding the neurophysiological correlates of conditions associated with restricted conscious experience such as sedation and anesthesia.

    Immediate

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Healthy right-handed men
  • Aged 18-35
  • Non-smokers
  • No metallic implants

You may not qualify if:

  • Younger than 18 or over the age of 35.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Study Officials

  • Robert Pearce, MD, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 13, 2008

Study Start

July 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

May 7, 2015

Record last verified: 2015-05

Locations

US(1)