Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study to Test the Usefulness of Magnetoencephalography (MEG) Imaging of Cognition in Children and Adolescents

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2010 by University of Nebraska
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00924300
First received: June 16, 2009
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

The primary objective of this protocol is to test the feasibility and utility of obtaining magnetoencephalography (MEG) recordings in healthy children and also in children who have a psychiatric or developmental disorder. Secondary objectives are to examine and compare typical and atypical motor, sensory, and cognitive functioning as recorded by MEG, and to identify subpopulation groups for which MEG may be optimal in order to establish feasibility of future hypothesis-driven MEG research.


Condition
Cognition

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) Studies of Typical and Atypical Cognitive Processes in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • MEG activation [ Time Frame: course of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients
children and/or adolescents with psychiatric disorder
controls
typically-developing children/adolescents

Detailed Description:

Healthy children and those who have a psychiatric or developmental disorder will undergo MEG recording to evaluate whether such children are candidate MEG subjects. Essentially, this feasibility study will examine whether children can remain still enough, complete simple tasks, and produce neurophysiologically consistent responses that would warrant full size studies.

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

children and adolescents with or without a psychiatric disorder

Criteria

Inclusion Criteria:

  • May or may not have a psychiatric or developmental disorder diagnosis.
  • Outpatient at study entry.
  • Age 4-18 (inclusive).
  • Male or female.
  • Have ability to sit still for 5 minutes or longer.
  • Have ability to comply with basic instructions.
  • Provide written informed assent if willing and able, per local IRB requirements before any study specific procedures are performed.
  • Parent or legal guardian provide written informed consent before any study specific procedures are performed.

Exclusion Criteria:

  • Ferrous metal permanently attached on or implanted in their body.
  • Metal braces on teeth (i.e. Invisalign braces and cavity fillings are permitted).
  • Has major medical condition, including cancer or hepatitis.
  • Has confounding multiple psychiatric and/or developmental diagnoses, as judged by the principal or co-investigator.
  • Known history or diagnosis of alcohol or substance abuse/dependence.
  • Unable or unwilling to comply with the protocol.
  • Anyone deemed as not appropriate for study participation, as deemed by the principal investigator.
  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: NCT00924300

Locations
United States, Nebraska
University of Nebraska MEdical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Tony W Wilson, PhD    402-552-6431    tony.w.wilson@gmail.com   
Sub-Investigator: Christopher J Kratochvil, MD         
Principal Investigator: Tony W Wilson, PhD         
Sub-Investigator: Diane May, APRN         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Tony W Wilson, Ph.D. University of Nebraska
  More Information

No publications provided

Responsible Party: Tony W Wilson, PhD, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00924300     History of Changes
Other Study ID Numbers: 217-09-FB
Study First Received: June 16, 2009
Last Updated: January 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
feasibility of MEG in pediatric populations

ClinicalTrials.gov processed this record on November 23, 2014