Skip to main content
Clinical Trials/NCT00924300
NCT00924300
Completed
Not Applicable

Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) Studies of Typical and Atypical Cognitive Processes in Children and Adolescents

University of Nebraska1 site in 1 country36 target enrollmentJuly 15, 2009
ConditionsCognition

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognition
Sponsor
University of Nebraska
Enrollment
36
Locations
1
Primary Endpoint
Magnetoencephalography (MEG) activation
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2009
End Date
September 1, 2017
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Magnetoencephalography (MEG) activation

Time Frame: 2-4 hour single visit

Task assignment is not randomized, but will be selected based upon age, developmental level of abilities, and disorder of interest, resulting in subjects and subgroups completing different tasks chosen by the principal investigator. Tasks include: auditory stimulation, visual stimulation, somatosensory stimulation, motor tasks, and baseline brain function. While the assigned tasks are performed, the MEG will silently record neuromagnetic responses on a 306-channel whole head Vector View system.

Study Sites (1)

Loading locations...

Similar Trials