CognitionNCT00924300
Study to Test the Usefulness of Magnetoencephalography (MEG) Imaging of Cognition in Children and Adolescents
An observational study of Cognition, run by University of Nebraska at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2009to 1 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: children and adolescents with or without a psychiatric disorder
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) Studies of Typical and Atypical Cognitive Processes in Children and Adolescents
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.
Read the 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
- Keywords
- feasibility of MEG in pediatric populations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients | children and/or adolescents with psychiatric disorder | |
| controls | typically-developing children/adolescents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-4 hour single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study start15 Jul 2009
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tony W Wilson, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924300
- Sponsor's protocol ID
- 0217-09-FB
- Status last verified
- Sep 2023
- First submitted
- 16 Jun 2009
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) Studies of Typical and Atypical Cognitive Processes in Children and Adolescents
- ClinicalTrials.gov ID
- NCT00924300
- Acronym / sponsor ID
- 0217-09-FB
- Conditions
- Cognition
- Keywords
- feasibility of MEG in pediatric populations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 15 Jul 2009 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | –children and/or adolescents with psychiatric disorder |
| controls | – | –typically-developing children/adolescents |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- children and adolescents with or without a psychiatric disorder
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony W Wilson, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognition, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetoencephalography (MEG) activation (time frame: 2-4 hour single visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.