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

Cognition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924300
• Other study ID #: 0217-09-FB
• Status: Completed
• Start date: July 15, 2009
• Est. completion date: September 1, 2017

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognition

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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