Difference between revisions of "User Guidelines"

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== Initiating a MEG Study ==
 
== 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 description that the appointment is for:
 
::::-- '''''Equipment Testing ''''' - indicate that the appointment is for a “System Test or Equipment Test” (if technical support is needed indicate with staff support).
 
::::-- '''''Programming / Scripting''''' - indicate "<u>Programming / Scripting</u>" and whether or not MEG staff assistance will be needed.
 
::::-- '''''Electrode Placement / "EOG/EEG/EMG" Montage Development''''' - if assistance is desired indicate"<u>technical assistance needed</u>" with EOG/EEG/EMG 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 the objective and / or your setup.
 
* Most new studies, if not all, will also require "User Training" 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 can be discussed and arranged during the MEG orientation tour.
 
* If you are piloting a new study, you must schedule time for User Training / Pilot Study via the web calendar as outlined below. Please indicate in the description that time is being requested for a “Pilot Study Setup, Pilot Study Observation or Pilot Study Practicum” so that MEG staff can be allocated as necessary.
 
   
  +
::::'''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.
<br>
 
   
  +
::::'''3. Equipment Testing / Task Setup:'''
== User Training ==
 
  +
::::::a. The MEG Core facility recommends initial pilot testing of task paradigm, equipment, software, etc. without a research subject.
'''For all scheduled MEG scans (including training and pilot studies) provide a simple, brief and accurate description of the protocol or paradigm indicating if any special equipment, assistance or setup is needed.'''
 
  +
::::::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:'''
<br>
 
   
  +
::::::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.
'''MEG Training / Pilots'''
 
  +
::::::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==
There is a three–step training program specifically designed so that users know how to to operate MEG equipment, can conduct a scan from start to finish and acquire practical experience under the guidance of MEG staff. The pilot is designed so that the user can become competent in performing all aspects of MEGs on their own subjects. MEG Core staff is available to provide pilot training and technical assistance as needed or requested. This training must be arranged with MEG staff and then scheduled via the MEG calendar.'''
 
  +
::1. All subjects participating in MEG studies are required to have a valid medical record number (MRN).
::♦'''Pilot / Instruction/Setup''' – (without a subject) MEG training, setup instructions and equipment operation with the assistance of MEG staff.
 
::♦'''Pilot / Observation''' – (with a subject) instructions and observation of MEG setup and scan with the assistance of MEG staff.
 
::♦'''Pilot / Practicum''' – (with a subject) hands on training session running a subject during a MEG scan under the observation of MEG staff.
 
*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.
 
   
  +
::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.
<br>
 
 
== 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.
 
   
  +
::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 Pre-Screening==
 
==Subject Pre-Screening==
  +
::'''3. 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.'''
 
  +
::::a. 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.
   
  +
::::b. It will be the responsibility of the PI to pre-screen subjects for the below listed contraindications during the selection process.
  +
::::c. Investigators may use the MEG Screening Questionnaire and/or Handedness Form as a subject evaluation / screening tool (under construction).
   
'''<u>Conditions That Will Rule Out a Subject:</u>'''
+
::::::Conditions That Will Rule Out a Subject:
:*'''Cardiac Implants''' - Cardiac pacemaker / Cardiac or neural defibrillators
+
::::::::• Cardiac pacemaker / Cardiac or neural defibrillators
  +
::::::::• Metal fragments in the eyes
:*'''Magnetic Implants''' - Any magnetic implantation / Implants made from iron (ferrous products)
 
  +
::::::::• Metal plates, pins or bolts in head
:*'''Mechanical Implants''' - Any mechanical implantation; any thing that has a motor
 
  +
::::::::• Any magnetic implantation / implantations made from iron (ferrous products)
:*'''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
 
   
  +
::::::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)
   
'''<u>All MEG subjects should be screened for the following items which may cause recording artifact.</u>'''
+
::::d. All MEG subjects should additionally be screened for the following items which may cause recording artifacts.
::-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
 
   
  +
::::::Conditions That May Rule Out a Subject:
<br>
 
  +
::::::::• 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
  +
  +
::::e. The confidentially of the MEG Subject Screening Questionnaires and Handedness Forms will be the primary responsibility of the study’s principal investigator.
   
 
== Subject Instructions ==
 
== Subject Instructions ==
'''Users/PIs are responsible for giving subjects instructions prior to any scheduled procedure.'''
 
 
   
  +
'''Users/PIs are responsible for giving subjects instructions prior to any scheduled procedure.'''
::'''<u>Subjects should be informed not to wear these items:</u>'''
 
   
  +
::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
  +
::::::::• 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.
::'''<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>

Revision as of 22:18, 17 August 2018

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 a 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 the MEG Orientation.
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 (Under construction).
c. Scientific staff in NIMH IRP labs at the doctoral level 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 and technologist, Judy Mitchell.

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.

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

3. Subject Pre-Screening
a. 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.
b. It will be the responsibility of the PI to pre-screen subjects for the below listed contraindications during the selection process.
c. 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)
d. 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
e. The confidentially 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.