Difference between revisions of "User Guidelines"

From MEG Core
Jump to navigation Jump to search
m
 
(83 intermediate revisions by 4 users not shown)
Line 1: Line 1:


===== Becoming a User =====
== Becoming a User: Training and Authorization ==
* User groups are required to have an IRB approved protocol with a description of the intended MEG research before a user account ID or scanning time can be assigned.
* A Facility Access Request must be filled out electronically (http://kurage.nimh.nih.gov/meglab ) to establish a user account. Filling out this request will initiate the process of establishing a user account ID and password.
* The account ID and password will give users access to the scheduling calendar and also provide access to the MEG Core Facility data storage system. All requests must be sent electronically.
* The account ID information will be emailed to the email address provided in the Facility Access Request Form, generally within 24 hours, if not call the Staff Engineer at 301/402-2362.


::'''1. MEG Orientation'''
<br>
::::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.''' [https://kurage.nimh.nih.gov/nih/staff/form.html 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'''
===== Required Personnel at MEG Sessions =====
:::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.
'''When performing a MEG scan there must be at least two persons assisting with the study.'''


::::a. The first step in becoming an authorized independent user is to attend MEG orientation/training.
* Two people are required to be present during an MEG study, however, only one person <u>must be</u> capable of operating the equipment.
::::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 [https://kurage.nimh.nih.gov/nih/staff/form.html MEG Core Staff Request Form].
* When there is a subject in the MSR, at least one person must be available to observe the subject at all times. If the subject were to suddenly take ill, one person must remain with the subject and the other person should be available to go seek appropriate help.
::::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.
* 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 torqued to one side or the other which might damage or break the plexiglass track.
::::d. Post-baccalaureate IRTA trainees can become authorized independent users, although they may not serve as authorized trainers.
* Two people are required to place the MEG bed for supine recording.
::::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 [https://kurage.nimh.nih.gov/nih/staff/form.html| MEG Core Staff Request Form].
<p>
::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==
===== MEG Orientation / Facility Tour =====
* Users <u>must</u> schedule / attend an informal MEG Orientation / Training to become familiar with the lab operations and equipment. During this training users will be instructed / assisted in filling out the MEG Facility Access Request which will establish a user account.
* Established users with new protocols will be required to complete a “new” Facility Access Request for each new protocol indicating the new protocol number.


::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 [[Policies and Procedures#Chair Operation|Chair Operation]]. The chair has a 300 lbs. maximum weight limit, and the bed (for supine recording) has a weight limit of 250 lbs.
<br>
::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 [[Policies and Procedures#Gantry Operation|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==
===== Initiating a MEG Study =====
* 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.
* Users must schedule a time to test their task / paradigm, equipment, software, etc. When scheduling indicate in the scheduling module that the appointment is for a “system test”.
* Also indicate whether programming or scripting support will be needed for the stimulus program.
* Also indicate whether technical support is needed – i.e., training or assistance with EEG/EP electrode placement or setup. If you have a specific electrode setup or placement and require MEG Core staff assistance you must provide a detailed description of your setup.
* Most protocols will require 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. Usually this will be discussed and arranged during the MEG orientation tour.
* 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”.


::1. User Feedback: Users are encouraged to make suggestions and provide feedback to MEG staff, by directly contacting the lab manager [mailto:anna.namyst@nih.gov Anna Namyst], staff scientist [mailto:holroydt@mail.nih.gov Tom Holroyd], and director [mailto:nugenta@nih.gov Allison Nugent].
<br>


::2. Problem Reporting: Users are responsible for reporting complications, incidents, or problems that occur involving the facility via the [https://kurage.nimh.nih.gov/nih/staff/form.html| Staff Support Form]. Select "Other" from the drop down menu and describe the issue in the comment box. Problems can also be reported in the [https://kurage.nimh.nih.gov/nih/AppendixB/form.html| Post-Scan Report Form]. 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.
===== User Training =====
'''There is a three step training program specifically designed so that users can acquire practical experience. The user is expected to become competent in performing all aspects of MEGs on their own subjects. MEG Core staff is available to provide training and technical assistance as needed.'''
::*'''Instruction''' – (without a subject) MEG setup instructions and equipment operation.
::*'''Observation''' – (with a subject) instructions and observation of MEG setup and scan.
::*'''Practicum''' – hands on training session running a subject during a MEG scan.
*Users must provide their own volunteer subject for training; if this is an external volunteer, he/she must be consented according to IRB guidelines.
*User training must be scheduled via the web-based calendar indicating that the appointment is for specific training, i.e., "Training - Instruction", "Training - Observation", "Training - Practicum" so that we can schedule the proper MEG personnel to assist with the training.


::3. Equipment Failure: Users are also responsible for reporting any equipment failure or any equipment that may not be working properly via the [https://kurage.nimh.nih.gov/nih/staff/form.html| Staff Support Form]. Any equipment that is inoperable or broken should be labeled as such, and the staff scientist, [mailto:holroydt@mail.nih.gov Tom Holroyd], director, [mailto:nugenta@nih.gov Allison Nugent], and lab manager, [mailto:anna.namyst@nih.gov Anna Namyst] should be informed immediately.
<br>


==User Log and Scan Documentation==
===== Subject Registration & Consenting=====
'''All subjects participating in MEG studies are required to have a valid medical record number (Medical Information System /MIS #).'''
*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 MIS#.
*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.
*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.
*It will be the responsibility of the PI to assure that subjects have signed the appropriate consent form.


::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.
<br>
::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. '''The log book should be kept closed when not in active use'''.
::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. Some sample forms are available here:
::::[[image:pdf.png]] [[Media:Data Collection Information Sheet.pdf | Basic MEG Data Collection Information Sheet]]
::::[[image:pdf.png]] [[Media:MEG_DATA_COLLECTION_INFORMATION_SHEET_V2.pdf | MEG Data Collection Information Sheet]]
::::[[image:word.png]] [[Media:MEG_DATA_COLLECTION_INFORMATION_SHEET_V2.docx | Editable MEG Data Collection Information Sheet]]


== Initiating a MEG Study ==
=====Subject Pre-Screening=====
'''Although MEG/EEG poses no known risk to subjects, certain physical conditions may make subjects ineligible to participate in scanning. Some subjects will be ruled out for participation in scanning due to factors involving metallic foreign bodies which may prevent obtaining artifact free data. It will be the responsibility of the PI to pre-screen subjects for the below listed contraindications during the selection process.'''


::'''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.
'''<u>Conditions That Will Rule Out a Subject:</u>'''
:*'''Cardiac Implants''' - Cardiac pacemaker / Cardiac or neural defibrillators
:*'''Magnetic Implants''' - Any magnetic implantation / Implants made from iron (ferrous products)
:*'''Mechanical Implants''' - Any mechanical implantation; any thing that has a motor
:*'''Head Size''' - any head size greater than 59-60 cm; subject’s head is too large to fit in the helmet
:*'''Weight''' - when using the chair the weight limit is about 300 lbs; for the bed it is about 250 lbs


::'''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:'''
'''<u>All MEG subjects should be screened for the following items which may cause recording artifact.</u>'''
::-Surgical aneurysm clips
::-Shrapnel
::-Intra-orbital metallic structures
::-Neurostimulators
::-Implanted pumps (i.e., Insulin pumps)
::-Metal plates, pins or bolts in head
::-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 ink)
::-Piercings


::::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 [https://kurage.nimh.nih.gov/nih/staff/form.html MEG Core Staff Request Form.]
::::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.
<br>
<br>


===== Subject Instructions =====
==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.
'''Users/PIs are responsible for giving subjects instructions prior to any scheduled procedure.'''
::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 [[Media:MEG Screening Questionnaire.pdf| MEG Screening Questionnaire]] as a subject evaluation / screening tool.


::::::Conditions That Will Rule Out a Subject:
'''<u>Subjects should be informed not to wear these items:</u>'''
::::::::• 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
::::::::(Head circumference will be too large to fit in the helmet. You can test your participant with the mock helmet insert in the MEG lab.)
::::::::• 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.
:*'''Bras''' with underwires
:*'''Makeup''' - mascara, eye liner, eye shadow or anything with glitter
:*'''Clothing''' containing metallic (shiny) threads or glitter
:*'''Metal on clothing''' -i.e., metal buttons, snaps or trimming


:::::: 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 (especially bluetooth enabled)
::::::::• Coins
::::::::• Eyeglasses
::::::::• Cell phones
::::::::• Earbuds/airpods
::::::::• 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). If their clothing is incompatible, they must change into scrubs, which are available in the NMR Center changing room.
'''<u>Subjects should be informed that metallic/magnetic items should not be taken into the Magnetically Shielded Room (MSR). These include such items as:</u>'''


::3. If there is any question about whether an object is magnetic, the object is not taken inside the MSR.
::-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)
::-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.
::-If there is any question about whether an object is magnetic, the object is not taken inside the MSR.
::-In order to help inpatients become familiar with MEG an inpatient orientation tour may be scheduled at the discretion of the PI or nursing staff.


<br>
<br>

Latest revision as of 10:48, 16 December 2021

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.
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 lab manager Anna Namyst, 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 Staff Support Form. Select "Other" from the drop down menu and describe the issue in the comment box. Problems can also be reported in the Post-Scan Report Form. 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 Staff Support Form. Any equipment that is inoperable or broken should be labeled as such, and the staff scientist, Tom Holroyd, director, Allison Nugent, and lab manager, Anna Namyst 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. The log book should be kept closed when not in active use.
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. Some sample forms are available here:
Pdf.png Basic MEG Data Collection Information Sheet
Pdf.png MEG Data Collection Information Sheet
Word.png Editable 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.
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 as a subject evaluation / screening tool.
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
(Head circumference will be too large to fit in the helmet. You can test your participant with the mock helmet insert in the MEG lab.)
• 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 (especially bluetooth enabled)
• Coins
• Eyeglasses
• Cell phones
• Earbuds/airpods
• 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). If their clothing is incompatible, they must change into scrubs, which are available in the NMR Center changing room.
3. If there is any question about whether an object is magnetic, the object is not taken inside the MSR.