मनोचिकित्सा विज्ञान का विभाग
एस.ओ.पी.
Standard Operating Procedures (SOPs) for Psycho-Metric Research Lab
Standard Operating Procedure for Electroencephalography (EEG)
The most important thing to remember when recording EEG is that there is no substitute
for clean data. While filters and other transformations can be applied to data after
recording, these can have adverse effects on the quality of the signal. Therefore, every effort should be made to ensure that the data that is collected is as clean, reliable and artefact-free as possible.
In the lab
In general, if you use the EEG laboratory, you should leave it as you would like to find it. With an increasing amount of users and experiments being run, time in the lab can be at a premium. Thus, time spent before a session having to clean up or rearrange after the last user is time wasted, especially when a participant is waiting. EEG sessions are time consuming for participants so having them waiting while the lab is being prepared is to be avoided. Having your participant in the chair for any time longer than is necessary can increase the likelihood of fatigue, with concurrent lapses in concentration and potential decrease in motivation and performance. Besides reducing the risk of these adverse confounds, an efficient manner in the laboratory with the participant serves to promote the air of professionalism and aptitude.
Most experiments can be run using the same hardware set-up (i.e., computers, monitors, amplifier, electrodes, etc.). In the recording booth, there is a monitor for users to see the recording computer output, allowing the impedance meter to be seen, as well as allowing the participants to see their own EEG signal. Do not switch cables from computers/monitors unless it is absolutely necessary. An already-confusing array of cables can be difficult to fathom, especially when a participant is waiting. If you must do this, remember to reconnect them to their original positions after your session.
Computers in the lab
The computers in the lab are to be used for EEG related activities only. Only use the internet for experiment- or analysis-related activity.
Before your session
Before your session, make sure that the amplifier is working by taking the following steps
Turn on the amplifier using the switch at the back.
On the EEG recording computer, open Neuropage link. Within this program, open the appropriate workspace by clicking ‘File’ – ‘Open Workspace’.
Click ‘Monitor’.
A blank signal should appear. This ensures that the recording software is recognising the amplifier.
Click ‘Stop Monitoring’ to end.
Turn on the computer which will present the tasks. Have your task(s) ready.
Have EEG caps ready. Make sure that the caps are clean and dry from their last use. This is very important as water or excess gel can cause the smearing or ‘bridging’ of the signal across electrode sites, leading to artefacts in the data.
Prepare the other consumables for the recording if they are not already laid out.
This includes ensuring adequate supplies of tissues, cotton-tipped buds, EOG ring stickers and holders, alcohol solution and syringes filled with electrode gel. Lay these out on the table for easy access during the session.
When the participant arrives
When the participant arrives, seat them on the chair in front of the monitor. Put the ‘Testing in Progress’ sign on the door. Measure the circumference of their head using the measuring tape which is hung on the handle of the door. This dictates which electrode cap is to be used.
Attach the electrodes to this cap (Note: you may have met the participant at a pre-testing session. If so, that is a good time to measure the head circumference allowing you to prepare the right cap in advance of the session). Ask the participant which form of strapping they would prefer; the chin strap or chest strap. Remember to measure the distance from the nasion (i.e., where the nose meets the face) to the inion (i.e., the projection of the occipital bone at the rear part of the skull) before putting the cap on (see Figure 1). This allows you to position the cap correctly. To decide where the cap sits, calculate 10% of the nasion-inion distance, and measure this distance from the nasion up along the forehead. This is the place where the front of the cap should lie.
If this is done correctly, all the electrodes on the cap should be located at the correct sites. When they have decided which strap they prefer, put the cap on and fasten it with this strap. When the cap is in place, the participant is ready to be gelled up.
Gelling the participant up
With the electrode cap in place, use a cotton swab to part the hair in the centre of each electrode so that scalp is visible.
When the participant is ready
When the impedance at each electrode is low enough and EOG electrodes are in place, recording can begin. Since movement artefact negatively impacts on signal quality in a manner that is difficult to describe to participants, it is good practice to show participants their own EEG signal. This can be done by exiting from the impedance mode in Recorder
and clicking ‘Monitor’
The EEG signal should now be visible both on the main recording monitor in the lab and the monitor in the recording cubicle. To illustrate the extent of interference caused by eye blinks and movement, ask the participant to watch their signal as they blink, cough, grind their teeth etc. This method normally proves very useful in minimising movement artefact in the data.
Blinking:
Coughing:
Grinding Teeth:
General Movement:
When you are ready
to begin recording
click Play/resume recording on the toolbar
Enter your file details and click ‘Save’.
Note: make sure that you are recording to the correct workspace and files.
When the session is over
When the session finishes, you must stop recording the EEG signal by pressing
the ‘Stop’ button on the toolbar
Then, in order to terminate monitoring status, click the ‘Stop Monitoring’ button on the
toolbar
Take the cap off the participant, paying particular attention when unclipping from the chest strap, as the clips may snap up and hit the participant’s chin which can be painful. Peel the cap off from the front backwards. Be wary of sites where hair has been tangled with the electrode; tugging at these sites can be painful, especially when hair is long.
Once the cap is off, place it on a towel and take the chest strap off the participant. Take the ‘Testing in Progress’ sign down from the door. Bring the participant to the bathroom,
and remember to bring the key with you. This should be in the plastic pocket in the top drawer of the locker. Show them the sink and shampoos and show them how to lock the door. Ask them to return to the EEG lab when they are finished to sign any debriefing (or other) forms. While they wash their hair, there is a good opportunity to save/transfer
their behavioural data and prepare the lab for cleaning. It also allows forms and any other documentation to be prepared before the participant is formally dismissed.
APPENDIX A: Dealing with participants
EEG Team should familiarise themselves with applicable sections of the PSI’s Code of Professional Ethics, and the BPS’s Code of Human Research Ethics.
Participants should be treated in a dignified fashion, and be as comfortable as possible during the research session. Attention should be paid to ensure that the participant is not
un-necessarily exposed to extremes of heat or cold, draughts, or extremely bright lighting. Air quality in the booth may deteriorate during a lengthy session – it may be necessary to
open the test booth door and run a fan to circulate air, if the air-conditioning is turned off.
Before the session begins, make it clear to the participant that they may withdraw from
the test at any time, and arrange a means for the participant to signal that they would
like to take a break. It would also help in this context, if the runs of trials were not excessively long, and the participant had the option to delay the start of the next run, so they could take a break. Be sensitive to any signs of distress shown by a participant in the test room, as these may indicate feelings of claustrophobia.
If a participant reports irritation from the electrode gel, or discomfort from the EEG cap the EEG Technician must offer to end the session immediately.
APPENDIX B: Tripping hazard
It is in the nature of EEG recording to have cables from some recording device attached to the participant. There may also be other trailing cables in the setup, depending on the research protocol, attached to such items as PCs, monitors, speaker systems, etc. While it is not possible to eliminate all such cabling, researchers are obliged to minimize any resulting trip hazard. Re-routing cables, and using extension cables for mains, VGA, USB, and PS/2 (legacy mouse/keyboard) leads, may reduce the risk to acceptable level.
The use of floor mats may also serve to reduce the trip hazard. EEG Technician should be mindful that however familiar they are with the EEG machine setup, it will be new to participants, so it is imperative that any unresolved trailing cables are brought to their notice – this applies to every participant, every time! Under no circumstance should any hanging cables (cables above the ground, which are under tension) be left in the natural path from the entrance door to the participant’s seat.
APPENDIX C: In case of fire
In the case of fire, EEG technician must disengage the participant from any recording equipment to which they are attached. It would be best if this resulted in the participant being free of all cables, but if it proves painful or impractical to remove e.g. the EEG cap, quickly, then it may be better to disconnect the amplifier and evacuate with the participant still attached to it.
Move quickly to the nearest stairwell, and lead the participant out of the building. Stay at the assembly point outside the main front door until further instructions.
APPENDIX D: Security of lab equipment, integrity of research setups
The access door to the Sound Lab is not to be jammed open at any time. If swipe access is required to the lab for legitimate research purposes, then that can be arranged through your appropriate school Security liaison person.
Research setups belonging to another researcher’s study are not to be interfered with, except with the consent of the other researcher. If the existing setup is preventing work on a new researcher’s study, then it should be brought to the attention of the existing researcher, the PI/supervisor of the new study, or a member of technical staff.
Standard Operating Procedure for FIRE HAZARD
Perform - thorough assessment for burn injuries, including the entire posterior as well as anterior body surface areas.
Alert/Activate - Pull the nearest alarm and call 101.
Confine - Close all doors to the hazard or fire area
Extinguish/Evacuate - Extinguish using the closest fire extinguisher if the fire impedes your evacuation.
Repetitive Transcranial Magnetic Stimulation (rTMS) Standard Operating Procedure
To ensure the safe, ethical, and reproducible use of TMS in research with human subjects
2. Introduction
rTMS is a method of non-invasively stimulating the brain. It has been used as a therapeutic and research tool with human subjects for more than 25 years and is generally regarded as safe and well tolerated. Seizure is the most serious potential adverse event. Several cases of accidental TMS-induced seizures prompted the establishment of consensus safety guidelines (Wasserman et al., 1998; Rossi et al., 2009; FDA, 2011; Rossini et al., 2015). The risk of seizures and other adverse events can be minimized by properly screening subjects and by constraining stimulation parameters within prescribed limits.
3. Scope
This Standard Operating Procedure applies to all procedures conducted with adult subjects at the Neuromodulation Lab, Department of Psychiatry, JN Medical College, AMU, Aligarh.
4. Definitions
1.TMS. Transcranial magnetic stimulation (TMS) is the application of a rapidly changing magnetic field to the head of a human subject with the purpose of inducing electrical activity in the brain. TMS is delivered as discrete pulses of energy.
2.sTMS and rTMS. Single-pulse TMS (sTMS) is the delivery of single-pulses separated in time by more than 1 second. Repetitive TMS (rTMS) is the delivery of trains or bursts of stimuli at a frequency of 1 Hz or greater.
3.TMS operator. The TMS operator controls the TMS equipment and takes direct responsibility for patient care during a TMS session. The TMS operator may be the Consultant/ Senior Resident/ Junior Resident from the Psychiatry Department.
4.Serious adverse event. A serious adverse event is an unintended medical problem that requires medical intervention, causes persistent disability, or threatens life.
5.Seizure. An epileptic seizure is a period of abnormal synchronous brain activity that causes a temporary change in behavior or consciousness. Typically, rTMS-associated seizures are self-limited (lasting less than 5 minutes) and do not require medical intervention, cause persistent disability, or threaten life.
6.Specific procedures
a. Informed consent. Before
each rTMS session,
the rTMS operator
will verify that
the subject has
provided written informed consent for the planned rTMS protocol.
b. Screening of subjects. At the beginning of each rTMS session, the patient will complete the rTMS Safety Screen (attached) or review a previously completed form and update it with any changes. This form will be reviewed by the rTMS operator
c. Personnel. The rTMS operator must be present in the room with the subject whenever rTMS is being administered. An assistant may deliver rTMS to the subject but only under the direct supervision of the rTMS operator.
d. Hearing protection. During rTMS, the subject will wear earplugs with 30-dB minimum attenuation.
e. Protection
of electronic devices.
During rTMS, the subject will set aside
personal electronic
devices (e.g., mobile phones, credit cards) to protect them from damage.
f. Patient protections. TMS does not pose any known risks to the patients when used properly.
Hearing protection is recommended but not required
for patients in the room during rTMS. Pregnant
individuals should preferably avoid rTMS because the fetal risks are unknown.
g. rTMS parameters. Before an rTMS protocol is initiated, the device settings
(e.g., intensity, frequency,
pulse-train duration, and inter-train interval)
will be checked
against parameters stated in the approved
protocol.
h. Side effects. Subjects
receiving TMS for the first time (or receiving a type of stimulation new to
them) will be warned about
expected side effects
near the site of stimulation: tapping sensations,
muscle twitching, and eye blinking.
i. Discomfort. If a subject
experiences pain or other discomfort, the stimulation will be paused or
adjusted until the subject is satisfied.
Subjects may discontinue the TMS session at any time, for any
reason, without negative consequences to them.
j. Seizure. rTMS has rarely caused seizures in
susceptible individuals. If the
subject develops abnormal or
unexpected movements, or fails to respond to questions, the TMS operator should presume that a seizure
is
occurring. In that case, the stimulator will be immediately removed from the subject, nearby objects will
be moved out of the way to prevent
injury, and the subject will be moved into a comfortable
position (on
their side, if possible). Immediate care to be provided by treating
doctor on lines of seizure
management
protocol.
k. Adverse
event reporting. If a seizure or serious adverse event occurs during or
soon after a TMS
session, the
TMS operator will report the event to the Chairman, Department of Psychiatry within 24 hours.
Adverse events should also be reported strictly in accordance with study-specific protocol.
Standard Operating Procedure for OPD/IPD WORK DURING COVID-19
• Observe social distancing measures at all times (minimum 2 meters)
• Clear safety standards for PPE & IPC
• Appropriate appointment scheduling, management, discharge, and referral of patients
• Only non AGP care to be given with appropriate PPE (eye protection, surgical masks, disposable apron & gloves)
• Intervention to minimum, to reduce exposure risk
• Using one-way entry/exit for patient flow
• Cleaning and decontamination of area before and after every patient daily
PPE: personal protective equipment
IPC: infection prevention & control
AGP: aerosol generating procedures
Electroconvulsive Therapy (ECT) Standard Operating Procedure
Before Procedure
Written informed Consent: Prior to receiving the first Electroconvulsive therapy (ECT) treatment, patients will be provided with consent forms to review and sign. ECT is a voluntary treatment, and you can withdraw this consent at any time.
Patient Instructions:Because electroconvulsive therapy is performed under general anaesthesia, do not eat, drink, or smoke after midnight on the days of treatments. On the day of procedure, do not wear jewellery or contact lenses.
During Procedure
During the ECT treatment: Patients will receive medications through the IV line that will put them to sleep for the duration of the treatment. Once asleep, patients will receive a muscle relaxant to help minimize movement during the procedure and a bite block will be placed in the mouth to protect teeth. An oxygen mask will be used to help patients breathe properly and small, adhesive electrode pads will be placed on the body and scalp which will allow the treatment team to monitor vital signs and brain activity before, during and after the procedure.
After the patient is placed under general anaesthesia, the treating doctor will use a controlled electrical current to induce a brief grand mal seizure that lasts up to two minutes. Because the patients are asleep, they won’t feel anything.
Following the ECT procedure, patients to be monitored for 30 minutes or as long as needed for the patient to be alert and oriented and steady on feet. Patients to be discharged shortly after.
After Procedure
- An adult must be present to drive the patient home and observe him/her for next 6-8 hours.
- Patient not to drive over the treatment course and for two weeks after treatments end.
- Following electroconvulsive therapy treatment, patients may experience one or more of the following side effects:
⁻ Nausea
⁻ Fatigue
⁻ Headaches
⁻ Confusion and grogginess
⁻ Short-term memory loss
⁻ Muscle aches and soreness
These side effects are normal and usually subside after a few days. In case of prolonged post ECT side effects, inform the treatment team at the earliest.
Equipment Check
It is the duty of the ECT team (Doctor and Nurse) to ensure availability and setup of:
ECT machine
Electrodes
Cardiac Monitor
Suction Machine
Pulse oximeter
Bite block
Blood Pressure machine
ECT During the COVID-19 Pandemic
Standard Operating Procedure for Psychiatry Teaching
Aims:To ensure that the learning environment of psychiatry education program is conducive to the ongoing development of explicit and appropriate professional behaviours.
§ Professionals should demonstrate adherence to the highest standards of personal, professional, and academic honesty and integrity.
§ To periodically evaluate the learning environment in order to identify positive and negative influences on the maintenance of professional standards.
§ To not discriminate against students on the basis of age, race, colour, ancestry, place of origin, ethnicity, political beliefs, religion, marital status, family status, physical or mental disability, sexual orientation, or gender identity.
§ To communicate respectfully with others both verbally and in writing.
§ To respect the privacy and confidentiality of those to whom we owe that duty.
Undergraduate teaching:
1. Lectures: The course work is divided among all the faculty members in the beginning of the session according to their respective thrust areas. The teaching schedule for the entire session is passed by the members of the BOS of the department.
2. Clinical demonstrations in OPD/Wards:Undergraduate students to be engaged in patient assessment (History and Examination) along with clinical demonstration of patient findings by faculty members for enhanced learning. Undergraduate students divided in small batches for better student-teacher interaction.
3. Neuromodulation, EEG and Psychology Skill Lab:Undergraduate students to be given demonstration of real time therapeutic interventions in Neuromodulation, EEG and Psychology skill labs respectively.
Post-graduate teaching:
1. Seminars:One seminar presentation is to be done by one post-graduate student every week (Saturdays) on his/her respective turn. The topics for the seminars are decided in the consultative meeting of faculty members held every 3 months.
2. Journal Clubs:One article from a reputed journal is discussed every week (Mondays) by one post-graduate student on his/her respective turn.
3. Case Discussions: One Postgraduate student presents a clinical casein front of faculty members every week (Wednesdays) on his/her respective turn.
4. Neuromodulation, EEG and Psychology Skill Lab:Postgraduate students to be trained in Neuromodulation procedures (ECT, rTMS) along with EEG recording and interpretation. Diagnostic and therapeutic psychological interventions to be demonstrated in the Psychology skill lab by clinical psychologist.
Standard Operating Procedure for OFFICE
§ Official Working Hours 8:00 AM – 4:00 PM
§ Maintaining records of all the documents received and dispatched from the department
§ To put up all the received documents before the chairman and carry out the duty in accordance with comments from the chairman
§ To make necessary arrangements for the exams conducted in the department
§ Filing documents in their respective files (Office file/Personal file/Circular file/ Notice Board file/ PG file/NAAC/IQAC/File for Minutes of BOS).
§ To maintain all the details of purchases and expenditure made by the department
§ The following record registers are maintained by the office:
Official Work Records
1. Register for receipt and dispatch of documents
2. Register for departmental meetings
3. Register for BOS
4. Register for leave record of teaching & non-teaching
5. Register for attendance of teaching, non-teaching, postgraduates, undergraduates, and interns
Clinical Work Records
1. Register for general patient registration in OPD
2. Register for student patient registration in OPD
3. Register for patient record in Psychiatry Ward
4. Register for equipment allocation to consultants & postgraduates
Financial Records
1. Register for purchase committee meetings
2. Register for record of all the instruments in the department
3. Register for record of repair of various items
4. Register for day-to-day expenses and consumable items
5. Register for Bank related work TA, DA.
6. Indent book register
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