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

NCT00924300 | Completed

• 1 other identifier: 0217-09-FB
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition

Keywords

feasibility of MEG in pediatric populations

Outcome Measures

Primary Outcomes (1)

• Magnetoencephalography (MEG) activation

  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.

  2-4 hour single visit

Study Arms (2)

patients

children and/or adolescents with psychiatric disorder

controls

typically-developing children/adolescents

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

children and adolescents with or without a psychiatric disorder

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Study Officials

• Tony W Wilson, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 18, 2009
• Study Start: July 15, 2009
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

US (1)