Subject Guidelines

Table of Contents:

• Subject Registration - MIS/CRIS #
• IRB Consent Forms
• Subject Pre-Screening
• Subject Screening
• Subject Pre-Scan Instructions

Subject Registration � Medical Information System MIS/CRIS #

All subjects participating in MEG studies are required to have a valid medical record number. A medical record number can be obtained by submitting a completed NIH-54 form to the Admissions Office (Building 10, Room 1C242).

It will be the responsibility of the principal investigator (PI) to make sure that subjects have gone through the appropriate registration process.

IRB Consent Forms

An IRB approved consent form must be signed by all subjects prior to participating in any MEG research study. Investigators are required to satisfy all Clinical Center documentation requirements.

You do not need to put in an order for an MEG scan. You do not need to have an MD present.

It will be the responsibility of the PI to assure that subjects have completed all consent forms and submitted all documentation.

Subject Pre-Screening

Although MEG/EEG poses no known risk to subjects, certain subjects will be ruled out for participation in research due to factors involving metallic foreign bodies which may prevent obtaining "good" data because of excessive artifacts. In addition, certain physical conditions may make subjects ineligible to participate.

It will be the responsibility of the PI to pre-screen subjects for the below listed contraindications during the selection process.

Conditions That will Rule Out a Subject Due To Excessive Artifact-

• Cardiac pacemaker / Cardiac or neural defibrillators
• Metal fragments in the eyes
• Metal plates, pins or bolts in head
• Any magnetic implantation / implantations made from iron (ferrous products)

The MRI scan may cause magnetization of fillings or other dental work. *Do not schedule a MEG scan within 24 to 48 hours after having an MRI scan as this may cause excessive artifact and result in recording inferior data.

Subject Screening

In addition, certain physical conditions may create excessive artifact in recordings which may also produce inferior data. These subjects, therefore, may not be an optimal candidate for participation in a MEG scan.

Users may use the MEG Subject Screening Questionnaire (Note: some of the questions on this form are only relevant to NIMH normal volunteers) or their own screening instrument or procedures as a quality control device to screen subjects for participation in a MEG research study. The Handedness Questionnaire is also available for use as a screening device.

MEG staff will be available upon request to assist users with the screening device to determine if there are any contraindications that might make a subject sub-optimal or ineligible for participation. However, it will be the responsibility of the PI to screen subjects for the below listed contraindications.

Conditions That May Rule Out a Subject Due To Excessive Artifact-

• Surgical aneurysm clips
• Shrapnel
• Intraorbital metallic structures
• Neurostimulator
• Implanted pumps (i.e., Insulin pumps)
• Steel pins from root canals
• Metal rods, plates or screws in the body or mouth
• Ear implants (certain cochlear implants)
• Metal rods, plates or screws in the body or mouth
• Previous surgery (if metal was left in the body)
• Hearing aids (should be removed before scanning)
• Braces (causes severe artifact)
• Tattoos (may have metallic paint)
• Piercings (may have metallic ink)
• Movement disorders (i.e., ticks, restless legs, etc., any condition that may cause movement)

Other Considerations Which May Rule Out a Subject

• Vision / Hearing problems
• Problems using response devices

Consideration Which WILL Rule Out a Subject

MEG staff will determine if this consideration will make a subject ineligible for participation at the time of the scheduled scan.

• Head size (subject�s head must be able to fit in the inside dimensions of the helmet)

Subject Pre-Scan Instruction

It will be the responsibility of the PI to give subjects instructions prior to any scheduled MEG procedure.

Subjects should not to wear these items as they may generate excessive artifact:

• Bras with underwires
• Makeup (mascara, eyeliner, eye shadow)
• Clothing containing metallic (shiny) threads or glitter
• Metal on clothing (i.e., metal buttons, snaps or trimming)

Subject should not take metallic or magnetic items into the Magnetically Shielded Room (MSR):

Anyone entering the MSR must first �de-metal� (remove any metal objects and empty pockets).

These include such items as:

• Belts
• Keys
• Watches
• Rings or other jewelry
• Coins
• Eyeglasses
• Cell phones
• Pagers
• Small metal objects such as hair pins, staples, paper clips, safety pins, etc.
• Credit cards

If there is any question about whether an object is magnetic do not take the object inside of the MSR.

Do not take shoes into the MSR. Remove your shoes before entering the MSR to prevent any magnetic dust from getting into the room.

Any subject who arrives unprepared i.e., have magnetic parts on their clothing that cannot be easily removed, may be issued non magnetic clothing which will be provided by staff.