Clinical trial NCT00924300: Study to Test the Usefulness of Magnetoencephalography (MEG) Imaging of Cognition in Children and Adolescents
Official title: Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) Studies of Typical and Atypical Cognitive Processes in Children and Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognition
Keywords: feasibility of MEG in pediatric populations
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2009-06-18
Enrollment: 36
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: children and adolescents with or without a psychiatric disorder

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.

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.

Primary outcomes:
measure: Magnetoencephalography (MEG) activation
timeFrame: 2-4 hour single visit
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Tony W Wilson, PhD
role: PRINCIPAL_INVESTIGATOR
References: