Functional Magnetic Resonance Imaging (fMRI) Findings in Children With Early Exposure to General Anesthesia

August 1, 2012 updated by: Thomas Taghon, Nationwide Children's Hospital

A Comparison of Functional Magnetic Resonance Imaging (fMRI) Findings in Children With and Without a History of Early Exposure to General Anesthetics

General anesthetic medications have been shown to cause neuronal cell death in the brains of infant rodents. Ethanol and general anesthetics both act on NMDA and GABA receptors,and appear to have similar mechanisms of toxicity in the immature rodent brain. Functional MRI (fMRI) is a technique developed for mapping brain activation and has been utilized to examine how the brains of children with a history of early exposure to ethanol function differently from children without such a history. This study will utilize fMRI to look for specific changes in brain activation patterns in children with a history of early exposure to general anesthesia, as compared to children without such exposure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children from Nationwide Children's Hospital

Description

Inclusion Criteria:

  1. Children ages 10-17 years with an history of exposure to general anesthesia for at least one hour in duration during the ages of 0-24 months of age.
  2. The cognitive ability to complete fMRI imaging.
  3. Consent of the subject's guardians and assent of the subject.
  4. Right hand dominance.
  5. English language speaker.

Exclusion Criteria:

  1. Subjects with known possibility or knowledge of pregnancy.
  2. Documentation of hemodynamic or respiratory instability documented on the anesthetic record
  3. Subjects with the inability to complete MRI imaging without sedation.
  4. History of prenatal ethanol exposure.
  5. History of exposure to antiepileptic medication.
  6. History of Attention Deficit Disorder (ADD), or Attention Deficit Hyperactivity Disorder (ADHD)
  7. History of traumatic brain injury
  8. History of psychiatric disease or exposure to psychoactive medications.
  9. History of substance abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal controls
Other: fMRI
fMRI and a response inhibition task to examine activation patterns in the prefrontal cortex and caudate nucleus
Exposure to anesthesia
Other: fMRI
fMRI and a response inhibition task to examine activation patterns in the prefrontal cortex and caudate nucleus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of fMRI as a tool
Time Frame: one time 10 to 17 yrs. post-anesthesia
To evaluate the use of fMRI as a tool to investigate the functional consequence of exposure to general anesthetic medications during early brain development
one time 10 to 17 yrs. post-anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain activation patterns
Time Frame: one time 10 to 17 yrs. post-anesthesia
To compare brain activation patterns in children with and without a history of early exposure to general anesthetic medications while peforming a specific task (go/no-go).
one time 10 to 17 yrs. post-anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Investigators

  • Principal Investigator: Thomas Taghon, DO, Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 26, 2010

First Submitted That Met QC Criteria

October 26, 2010

First Posted (Estimate)

October 27, 2010

Study Record Updates

Last Update Posted (Estimate)

August 2, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB07-00456

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Exposed to Anesthesia

Clinical Trials on fMRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe