User Guidelines

Becoming a User: Training and Authorization

1. MEG Orientation

a. Users must schedule / attend an official MEG orientation to become familiar with the lab operations and equipment. Any personnel present in the MEG laboratory during acquisition must complete the MEG orientation, including all clinical support staff. Request training here.

b. Users attending orientation will be assisted in filling out a Facility Access Request to gain lab and data access.

2. Authorized Independent User Requirements

At least one of the persons in attendance at every MEG session must be authorized to operate the MEG independently. The authorization process involves several steps. To become authorized, the user is expected to become competent in performing all aspects of MEGs. MEG Core staff is available to provide training and technical assistance. Steps to becoming an authorized independent user appear below.

a. The first step in becoming an authorized independent user is to attend MEG orientation/training.

b. Following completion of the orientation, each new user must assist with a minimum of two (2) MEG sessions, and independently perform one additional MEG session, in the presence of MEG Core facility staff or an authorized trainer. Additional observed sessions may be required to achieve competency. To request MEG Core Staff assistance/training use the MEG Core Staff Request Form.

c. Scientific staff in NIMH IRP labs (at the doctoral level, or with R.EEG.t certification) with at least one full year of experience as an independent user may be named as an authorized trainer at the discretion of the MEG core facility.

d. Post-baccalaureate IRTA trainees can become authorized independent users, although they may not serve as authorized trainers.

e. New users who have performed all procedures in the presence of MEG Core staff (or an authorized trainer) and have attained competency in all skills will be added to the authorized independent user list. The authorized independent user list and the authorized trainer list will be maintained by the lab manager.

Required Personnel at MEG Sessions

When performing an MEG scan there must be at least two persons assisting with the study.

1. The MEG core facility requires that at least two persons are present in the room at every MEG session. Both persons must have completed the MEG orientation. One person must be monitoring the subject inside the MSR at all times. One person may be clinical support staff. One person may be MEG Core facility staff, with prior approval and notice of at least one week. Please use the MEG Core Staff Request Form (Under construction)

2. Two persons are required so that a subject is never left alone in the MSR without an observer in the control room. Two people are required to move / position the MEG chair, one person on each side, so that the chair glides evenly on the track and is not damaged. Two people are required to place the MEG bed for supine recording.

2. One of the two persons present at every MEG session must be authorized to operate the MEG independently (or must be MEG core facility staff).

3. Any invasive studies (i.e. studies involving infusions, blood draws, etc.) must be accompanied by personnel with NIH CC clinical credentials. This person must have completed the MEG orientation, and can also serve as the second person.

4. Upon review of the IRB approved protocol for non-invasive studies involving research subjects who are not classified as healthy volunteers, the MEG core facility may require NIH CC credentialed staff to be present during recordings.

5. One person must be monitoring the subject in the MSR at all times.

Lab Safety

1. Chair / Table Safety – Care should be taken when raising the chair / table when you have a subject sitting or supine in the gantry. Operating instructions are below in Chair Operation. The chair has a 300 lbs. maximum weight limit, and the bed (for supine recording) has a weight limit of 250 lbs.

2. Gantry Safety – Never adjust the gantry (tilt or angle) when a subject is seated in the chair or lying on the table. Instructions are available in Gantry Operation.

3. If a medical emergency occurs call 111. For Fire or Police call 911. For any other emergency contact the director or staff scientist for assistance at the phone numbers posted in the lab.

4. Magnetically Shielded Room (MSR) Guidelines: There are no known risks associated with MEG/EEG recordings. Although wearing metal objects while in the MSR (Magnetically Shielded Room) is not harmful to the individual, bringing metal objects in the MSR can result in a poor quality data. In addition, bringing magnetized objects into the MSR can cause trapped flux in the SQUIDS causing them to unlock, requiring maintenance before recording can continue. Thus, we have established these guidelines:

a. Subjects should not bring any metal objects inside the MSR. Any subject entering the MSR must first “de-metal” (remove any metal objects; empty pockets; remove jewelry, hairclips, pens, clipboards etc.). These include belts, keys, watches, rings/earrings, necklaces, coins, eyeglasses and pieces of clothing with metal parts such as bras with underwires or bras with metal adjustment rings. Non-metallic subject clothing is available in the laboratory upon request.

b. No one (not subjects / nor MEG Users) should bring electrical equipment inside the MSR. Objects such as cell phones, pagers, cameras, flashlights, or any other electrical equipment are strictly forbidden.

c. Magnets and anything magnetized is never allowed inside the MSR.

d. No one should wear shoes inside the MSR. To prevent any metal or magnetic dust from getting into the MSR shoes must be removed before entering the MSR, or shoe covers (provided) should be used.

e. Any “unapproved” equipment should not be brought into the MSR. Any “special” equipment must be approved by the director or staff scientist prior to its use.

f. Do not use small metal objects (i.e., staples, paper clips) around the MSR.

g. NO equipment will be left in the MSR other than the equipment that belongs in the MSR.

User Feedback and Problem Reporting

1. User Feedback: Users are encouraged to make suggestions and provide feedback to MEG staff, by directly contacting the staff scientist (Tom Holroyd) and director (Allison Nugent).

2. Problem Reporting: Users are responsible for reporting complications, incidents, or problems that occur involving the facility via the Problem Report Form (under construction). Any variance/problem occurring that affected subject safety should be reported immediately to the institute clinical director and the IRB by the investigators in addition the the MEG Core director; reporting of unanticipated problems or adverse events to the IRB is not the responsibility of the MEG Core facility.

3. Equipment Failure: Users are also responsible for reporting any equipment failure or any equipment that may not be working properly via the Problem Report Form (under construction). Any equipment that is inoperable or broken should be labeled as such, and the staff scientist (Tom Holroyd), Director (Allison Nugent) and Lab Technologist (Judy Mitchell) should be informed immediately.

User Log and Scan Documentation

1. Users MUST document any scan that they perform in the User Log Book. If a subject was set up for the MEG but the scan was not performed – that scan must still be logged in the User Log Book with a comment explaining why the study was not performed.

2. Noise collections and phantom studies should also be logged. If a data is collected, there should be an entry in the logbook.

3. Subject information and all other pertinent information must be filled out in the log book, i.e., date, PI name, operator’s initials, protocol #, subject’s initials, MRN, and the gantry position. Do not leave any blank entries.

4. Noise collections or pilot studies without a subject can be logged as such in the initial/MRN fields.

5. Users are encouraged to complete and retain run sheets for their own records. A sample form is available here:

MEG Data Collection Information Sheet

MEG Data Collection Information Sheet

Initiating a MEG Study

1. Study Design Review: Users must provide the director and/or staff scientist with a description of the research study design including information regarding setup requirements, software, and equipment needs.

2. Protocol Approval: User groups are required to have an IRB approved protocol with a description of the intended MEG research before any human subjects can be scanned.

3. Equipment Testing / Task Setup:

a. The MEG Core facility recommends initial pilot testing of task paradigm, equipment, software, etc. without a research subject.

b. MEG Core staff are available, upon request, to assist in troubleshooting during pilot testing, with at least one week's notice. Please indicate the need for any special training, i.e., training or assistance with EEG/EP electrode placement or setup on the MEG Core Staff Request Form (Under construction)

c. Users must schedule time via the web calendar for all testing. When scheduling indicate in the scheduling module that the appointment is for "pilot testing: no subject".

3. Pilot Studies:

a. The MEG Core facility recommends a pilot study to test equipment, paradigms / programs and refine procedures with a test subject. Users must provide their own volunteer subject; if this is an external volunteer, he/she must be consented according to IRB guidelines.

b. MEG Core staff are available, upon request, to assist during pilot testing, with at least one week's notice. Please indicate the need for any special support. Please use the MEG Core Staff Request Form (Under construction).

c. You must schedule time for the pilot study via the web calendar. Please indicate in the description that time is being requested for a “pilot study”.

d. Pilot studies with a subject are required to have two persons in attendance who have completed the MEG orientation (in addition to the subject). One person may be MEG Core facility staff.

Subject Registration & Consenting

1. All subjects participating in MEG studies are required to have a valid medical record number (MRN).

2. It will be the responsibility of the principal investigator (PI) to make sure that all outpatients and control subjects have gone through the appropriate registration process and have a valid MRN.

3. An IRB approved consent form must be signed by all subjects prior to participating in any MEG research study. Consent and documentation of consent will be the responsibility of the PI.

4. A doctor’s order is not required for an MEG scan but a progress note must be placed in the subject’s chart indicating the nature of the scan performed, the date, time, and protocol number. The patient’s condition and general performance should also be noted. The progress must also be signed by the appropriate personnel. Progress notes are solely the responsibility of the individual investigators.

Subject Pre-Screening

1. Although MEG/EEG poses no known risk to subjects, some subjects will be ruled out for participation in scanning due to factors involving metallic implants or foreign bodies which may prevent obtaining artifact free data.

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

3. Investigators may use the MEG Screening Questionnaire and/or Handedness Form as a subject evaluation / screening tool (under construction).

Conditions That Will Rule Out a Subject:

• 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)

An Additional Consideration Which Will Rule Out a Subject:

• Head size greater than 60 cm: if a subject’s head is too large to fit in the helmet

• Weight greater than 300lbs (seated recording) or 250lbs (supine recording)

4. All MEG subjects should additionally be screened for the following items which may cause recording artifacts.

Conditions That May Rule Out a Subject:

• Surgical aneurysm clips

• Shrapnel

• Neurostimulators

• Implanted pumps (i.e., Insulin pumps)

• Steel pins from root canals; a permanent retainer

• 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 contain metal)

Other Considerations Which May Rule Out a Subject:

• Movement disorders (i.e., ticks, restless legs, etc., any condition that may cause excessive movement)

• Vision / Hearing problems

• Problems using response devices

5. The confidentiality of the MEG Subject Screening Questionnaires and Handedness Forms will be the primary responsibility of the study’s principal investigator.

Subject Instructions

Users/PIs are responsible for giving subjects instructions prior to any scheduled procedure.

1. Users/PI’s are responsible for giving subjects instructions prior to any scheduled procedure.

Subjects should be informed not to wear these items:

• Bras with underwires

• Makeup/moisturizer/sunscreen of any kind

• Clothing containing metallic (shiny) threads or glitter

• Metal on clothing (i.e., metal buttons, snaps or trimming)

• Hearing aids

Subjects should be informed that metallic/magnetic items should not be taken into the Magnetically Shielded Room (MSR). These include such items as:

• Belts

• Keys

• Watches

• Coins

• Eyeglasses

• Cell phones

• Pagers

• Credit Cards

• Small metal objects such as hair pins, paper clips, safety pins, etc.

• Shoes (may have metallic dust particles on them)

2. It is the responsibility of the PI to inform subjects that if they arrive unprepared i.e., have metallic/magnetic parts on their clothing that cannot be easily removed, they may be asked to change into non-magnetic clothing which will be provided by staff.

3. If there is any question about whether an object is magnetic, the object is not taken inside the MSR.