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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Taghon, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01229514
First received: October 26, 2010
Last updated: August 1, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Exposed to Anesthesia
Other: fMRI

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Comparison of Functional Magnetic Resonance Imaging (fMRI) Findings in Children With and Without a History of Early Exposure to General Anesthetics

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Use of fMRI as a tool [ Time Frame: one time 10 to 17 yrs. post-anesthesia ] [ Designated as safety issue: No ]
    To evaluate the use of fMRI as a tool to investigate the functional consequence of exposure to general anesthetic medications during early brain development


Secondary Outcome Measures:
  • Brain activation patterns [ Time Frame: one time 10 to 17 yrs. post-anesthesia ] [ Designated as safety issue: No ]
    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).


Enrollment: 30
Study Start Date: October 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Exposure to anesthesia Other: fMRI
fMRI and a response inhibition task to examine activation patterns in the prefrontal cortex and caudate nucleus
Normal controls Other: fMRI
fMRI and a response inhibition task to examine activation patterns in the prefrontal cortex and caudate nucleus

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children from Nationwide Children's Hospital

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01229514

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Thomas Taghon, DO Nationwide Children's Hospital
  More Information

Publications:
Responsible Party: Thomas Taghon, Attending Anesthesiologist, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01229514     History of Changes
Other Study ID Numbers: IRB07-00456
Study First Received: October 26, 2010
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nationwide Children's Hospital:
Children
before
the age of 2 years

ClinicalTrials.gov processed this record on September 18, 2014