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

NCT ID: NCT00924300

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-15
• Study Completion Date: 2017-09-01

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.

Conditions

Cognition

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

patients

children and/or adolescents with psychiatric disorder

No interventions assigned to this group

controls

typically-developing children/adolescents

No interventions assigned to this group

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tony W Wilson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0217-09-FB

Identifier Type: -

Identifier Source: org_study_id