|Year : 2020 | Volume
| Issue : 3 | Page : 78-83
Guidelines for the safe operation of repetitive transcranial magnetic stimulation and transcranial direct current stimulation in clinical settings: An Indian perspective
Charu Singh1, Urvakhsh Mehta2, Nand Kumar3, Manisha Biswal Singh1, Shubh Mohan Singh4
1 Department of Medical Microbiology, PGIMER, Chandigarh, India
2 Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India
3 Department of Psychiatry, All India Institute of Medical Sciences, Delhi, India
4 Department of Psychiatry, PGIMER, Chandigarh, India
|Date of Submission||23-Sep-2020|
|Date of Decision||05-Mar-2021|
|Date of Acceptance||08-Mar-2021|
|Date of Web Publication||10-May-2021|
Dr. Shubh Mohan Singh
Department of Psychiatry, PGIMER, Chandigarh
Source of Support: None, Conflict of Interest: None
The COVID-19 pandemic is a major disruptive event of our times. It has necessitated changes in all aspects of health-care practices. Non-invasive brain stimulation procedures (NIBS) such as repetitive transcranial magnetic stimulation and transcranial direct current stimulation (TDCS) are no exceptions. The practice of NIBS in India in COVID-19 is expected to be hospital based and in a non-COVID setting. There are no specific guidelines for safe practice of NIBS in the Indian context for COVID-19. However, the Government of India (GOI) has from time to time issued guidelines for different aspects of hospital infection control practices. We present guidelines for safe practice of NIBS procedures, specifically repetitive transcranial magnetic stimulation and TDCS in the Indian context based on hospital infection control guidelines as issued by the GOI and the tertiary care hospital in North India where the authors work, available literature and the clinical experience of the authors.
Keywords: COVID-19, hand hygiene, non-invasive brain stimulation, repetitive transcranial magnetic stimulation
|How to cite this article:|
Singh C, Mehta U, Kumar N, Singh MB, Singh SM. Guidelines for the safe operation of repetitive transcranial magnetic stimulation and transcranial direct current stimulation in clinical settings: An Indian perspective. J Patient Saf Infect Control 2020;8:78-83
|How to cite this URL:|
Singh C, Mehta U, Kumar N, Singh MB, Singh SM. Guidelines for the safe operation of repetitive transcranial magnetic stimulation and transcranial direct current stimulation in clinical settings: An Indian perspective. J Patient Saf Infect Control [serial online] 2020 [cited 2021 Jun 15];8:78-83. Available from: https://www.jpsiconline.com/text.asp?2020/8/3/78/315744
| Introduction|| |
The ongoing COVID-19 pandemic has necessitated changes in the usual functioning of most hospital-based healthcare-related procedures. Non-invasive brain stimulation procedures (NIBS) are no exception.
Repetitive transcranial magnetic stimulation (RTMS) and transcranial direct current stimulation (TDCS) are the two commonly used NIBS. While RTMS and now more commonly TDCS can be home based, these technologies are at present mostly confined to hospitals and other clinics in India. Therefore, these guidelines are focussed primarily on the safe use of RTMS and TDCS in hospital settings in India. Hospital settings are more of a challenge than home-based settings, especially in the context of COVID-19 because of obvious possibilities of transmission of infections to health-care providers (HCP) and other patients by large numbers of possibly infected people visiting the premises, and the higher possibility of exposure to contaminated surfaces. These guidelines are based on the hospital infection control practices as recommended in the Postgraduate Institute of Medical Education and Research Chandigarh and other resources, and the clinical experience of the authors in running the brain stimulation service which consists of the procedures of RTMS and TDCS. These services are conducted in an outpatient setting and this setting can be considered a non-COVID area. A non-COVID area in a hospital can be considered to be one that has facilities for reasonable screening out of patients with suspected COVID-19 and is also not geared to function with known COVID-19 patients.
COVID-19 is a rapidly evolving situation as reflected in changes in guidelines issued from time to time by the Government of India (GOI). There is a recent article giving a broad outline of the use of NIBS in COVID-19. The guidelines in the present article are aimed at providing a framework for providing RTMS and TDCS services safely in clinical settings in a non-COVID hospital setting in an Indian context. With the number of patients with COVID-19 increasing, it is more than likely that services providing NIBS will encounter patients with COVID-19. This article does not however aim to outline the safe use of NIBS in patients with COVID-19 or the safe use of magnetic resonance imaging compatible stimulators. The guidelines in this article reflect the state of knowledge at the present time and this may change in the future.
However, none of these guidelines can replace the essentiality and centrality of maintaining source control, respiratory etiquette, aseptic precautions, hand hygiene, use of masks and physical distancing at all times.,
| General Considerations|| |
All potential patients should be counselled regarding the facts of COVID-19 and the elevated risk of contracting it in the hospital. This may be incorporated in hospital consent procedures. This is especially so for patients who are older or who have comorbidities that are known to be associated with poor prognosis in COVID-19.
RTMS and TDCS are administered in a form of sessions that usually last for 10–30 min. Most protocols involve the administration of one session (or sometimes more) per day. These sessions are administered on 5–6 days in a week (Saturday and/or Sunday are usually off days). A course of treatment can consist of daily sessions for 1–4 weeks or more.
It is advisable that protocols be devised in a way that one session per day is planned and so called 'accelerated' protocols involving multiple sessions in a day are avoided. It is also advisable that protocols be planned such that sessions get over in the minimum period of time and appointments be arranged in a way that waiting time is kept as less as possible.
Clinicians should be careful and have set protocol and outcome parameters with definite time points so that treatments do not continue beyond absolutely necessary in case of non-response or incomplete response.
| Training and Orientation|| |
All staff conducting these procedures should be trained in basic infection control and prevention (IPC) protocols [Refer [Table 1]]. This includes, hand hygiene, droplet, contact and airborne precautions, proper biomedical waste (BW) management and prevention of needlestick injuries. All new staff should receive orientation on the same and a record maintained of all orientation and on-job training sessions of IPC.
| Hand Hygiene|| |
SARS-Cov2 is an enveloped virus and is easily killed by soap and alcohol. The role of hand hygiene cannot be overemphasised in the prevention COVID-19. A hand washing sink (elbow or foot operated) with adequate supply of liquid soap and sterile tissue paper to dry hands should be provided. Hands must be washed with soap and water at the beginning of duty, end of duty, after using the washroom facility and at any time that hands are visibly dirty or contaminated with patient's secretions. At all other opportunities, alcohol-based hand sanitisers should be used. For both hand wash and hand rubs, all six steps recommended by the WHO should be followed for recommended times (40–60 s for hand wash and 15–20 s for alcohol hand rub).
Patients and accompanying family members should also be trained in hand hygiene and basic infection control practices (IPC) like respiratory etiquette.
| Premises and Equipment|| |
As mentioned above, the premises where NIBS is carried out is expected to be a non-COVID treatment area. RTMS and TDCS are usually outpatient procedures as practiced in our hospital.
The procedures should be carried out in a well-lit room of appropriate size to accommodate the equipment, a patient chair and at least one other chair for the person administering the treatment. This is necessary as the patient is not to be left alone or unobserved at any time. The recommended operating temperatures for both RTMS and TDCS are usually within the range of 10°C to 40°C., RTMS however has a tendency to overheat and in our opinion, air conditioning/cooling to maintain a temperature of 20°C–25°C can be considered essential for appropriate usage of the equipment and patient comfort.
As COVID-19 is spread through respiratory droplets, ideally rooms in which patients are housed or any procedures (especially aerosol generating procedures), should be under negative pressure. Dedicated air handling units (AHUs) should provide negative pressure facilities with an air at least 12 exchanges per hour. However, when this is not possible, ventilation should resemble natural ventilation with exhaust fans driving air out of the room onto the outside of the building to avoid stagnation of room air. If air conditioning is present (as is usually the case), the GOI guidelines for operation of air conditioners should be followed. Any items that cannot be cleaned and disinfected should be removed from the area and general hygiene should be maintained in the area.
Only essential personnel should be present in the room. Patients should be called by appointment to avoid overcrowding and to facilitate physical distancing (at least one metre) inside the room. A holding area outside the NIBS procedure room where physical distancing between waiting patients can be maintained is ideal. Alternately, patient cubicles (permanent or temporary with plastic curtains) can be constructed to achieve this. Windows can be opened for cross ventilation or exhaust fans be switched on all throughout to facilitate air exit from the room. Ideally, at any given time, only one patient should be administered NIBS and the operator should be present throughout. If it is essential that more than one patient receive NIBS simultaneously, it is advisable that partitions/cubicles be created for each treatment point. However, there is a need for each patient to have his/her own operator. It is not advisable for an operator/technician to handle more than one patient without practicing aseptic precautions between them.
The room in which RTMS and TDCS are to be administered should be cleared of all non-essential articles. Each morning the room should be cleaned with detergent and water with a contact time of at least 5 min or with a 0.1% hypochlorite solution. High touch surfaces like doorknobs should be cleaned with 0.1% hypochlorite solution with a minimum contact time of 20 min every few hours. Other disinfecting agents can be used as per the manufacturer's guidelines., Handles of patient chairs (such as plastic or dental chairs) can also be disinfected using the above process if possible or with alcohol swabs (isopropyl 70% or ethyl alcohol 70%) until the alcohol evaporates. The same procedure can also be used to clean a patient chair between procedures. Alternatively, environmental surfaces can be clean with 0.1% hypochlorite with a disposable antiseptic cloth between procedures. Disposable sheets should be preferred. Otherwise, bed sheets if used should be changed after every patient. Other frequently touched surfaces such as land phones, computer keyboards, and switches should also be disinfected once in every shift at least. In case of major blood or body fluid spillage, a 1% hypochlorite solution should be poured on the spill and a contact time of 20 min should be given before the spill is wiped off.
As personal items such as mobile phones, stethoscopes, and pens can get contaminated, these items should also be wiped with alcohol wipes.
The preparation of equipment should be guided by the producers specifications. For instance, the manufacturers of Magstim Rapid recommend the cleaning of the exteriors of the machine and the coil with a isopropyl alcohol moistened cloth. This procedure may be used between procedures as well. It is advisable that the patient be asked to get a tightly fitting rubber swimming cap that can be put on the head with respect to anatomical landmarks and the target area marked on it. We have used this method often and this can prevent direct contact between the coil surface and the scalp of the patient. The patient can be advised to carry the cap back home in a sealed bag and wash it with detergent and water at home every day.
The use of TDCS can be in two forms: Namely the conventional 1 × 1 TDCS and the high-definition TDCS. In both of these methods, it is advisable that as far as possible, disposable/one time use equipment be preferred. Non-disposable rubber head straps, electrodes, plastic holders and cables etc., should be cleaned as per the manufacturer's directions. Ideally leads should be sent for ethylene oxide sterilisation. Alternatively, they can be disinfected by swabbing with 70% isopropyl alcohol or ethyl alcohol or hydrogen peroxide solution. For instance conducting gel should be removed thoroughly from electrodes and holders with soap and water and thereafter with 2%–3% hydrogen peroxide solution with a cotton swab or a toothbrush. Neoprene caps should not be used across patients. After each use, the neoprene cap should be washed in detergent and water and hung up to dry.
The operator should try to minimise the time spent in close contact with the patient (for instance in setting up a protocol, applying the electrodes) and try to maintain a distance of at least 1 metre from the patient at all times.
| Patient and Operator Screening, Selection and Safety|| |
Currently, there are no specific COVID-19-related indications or contraindications for the use of NIBS. Patients and attendants planned for RTMS and TDCS should be entertained on scheduled appointments only and should be advised to wear a face mask before leaving home. Treatment facilities should ensure that there is a screening process that can identify operators and patients with symptoms consistent with a diagnosis of COVID-19 or patients otherwise prioritised for testing due to any reason (for instance history of contact with a patient confirmed to be suffering from COVID-19)., It is recommended that all those who screen positive should be first tested to confirm COVID-19 status. All patients and operators should be first screened each day that they arrive at the facility for NIBS sessions. The screening can be questionnaire based (for symptoms of COVID-19) or by the use of a thermal scanner. A log should be maintained for each day. The system requires back-up in case the NIBS operator has to be quarantined/isolated. Each healthcare facility should demonstrably make reasonable efforts to ensure that NIBS operators are free of infection through clinical screening and also testing wherever indicated. No symptomatic operator should handle patients. The operator should be tested for COVID-19 if symptomatic. As the sensitivity of a single nasopharyngeal swab is 71% and double swab is around 95%, at least two swabs should be sent. If the report is negative, the operator should nonetheless don a surgical mask while close to patients and observe respiratory etiquette.
All staff posted should be monitored for development if any symptoms related to COVID. Protocols of who to contact in case of symptoms and contact numbers should be made and circulated to all staff. Guidelines should be periodically updated according to emerging evidence.
In case a patient develops symptoms of COVID-19, a few days after the start of sessions, they should be tested and NIBS treatment withheld during the time that the result is awaited. Considering the evidence base for effectiveness of RTMS and TDCS, the decision to start or continue NIBS treatment in a patient with confirmed COVID-19 should be carefully weighed against possible benefits, other potential treatments available and the risk of transmission of infection to the operator or other patients. In our opinion, as most patients with COVID-19 with mild infection would get better in 2–3 weeks, it is probably prudent to wait until a patient is confirmed to be negative before starting or restarting treatment as the case may be.
However, many patients remain asymptomatic and some patients might be taken up for the procedure in the presymptomatic period (2–3 days before symptoms appear). Therefore, it is good policy to take precautions for all patients, irrespective of symptom or test report. If a test report is not available and the patient has respiratory symptoms and it is considered essential for any reason to continue treatment, he/she should be asked to wear a surgical mask throughout the process. The HCP in this scenario should wear at least a 3 ply surgical mask with a face shield. A distance of 1 m from the patient should be maintained.
RTMS and TDCS are usually safe and well tolerated procedures. The only treatment emergent adverse event of significance with regards to COVID-19 infection control is the remote possibility of an epileptic seizure (ES) in RTMS that may necessitate the immediate need for an aerosol generating procedure such as intubation or intravenous access to inject antiepileptics. However, in most cases ES can be anticipated as these patients usually have obvious risk factors such as sleep deprivation, organic brain insult, polypharmacy or use of medications that reduce the seizure threshold, the use of novel and high frequency RTMS protocols. It is advisable that all patients planned for RTMS be screened carefully for the possibility of seizure induction., The benefits of institution of RTMS in patients with risk factors for seizure induction should be weighed against potential risks. New and novel protocols, especially using prolonged high frequencies are probably best avoided.
Most importantly, a log book to be maintained having all the patient information including address and phone number as wee as all the health-care workers who came in his contact and his status to be followed for 14 days in case if he comes out to be positive within these days.
| Personal Protective Equipment|| |
The rational use of personal protective equipment (PPE) is important in clinical settings for judicious use of resources and also to ensure patient and operator safety. The guidelines governing the use of PPE are based on an assessment of the risk that the HCP is expected to encounter in a certain setting., While to the best of our knowledge, specific guidelines for PPE use for RTMS and TDCS have not been published, the following may be useful. RTMS and TDCS are non-aerosol generating procedures being carried out in a non-COVID area. As per the guideline as is current in our hospital, the following may be recommended. The minimum PPE required is a three layered surgical mask and single layer of gloves. If available, the use of a sterile linen gown is advisable which can be changed before each administration. A face visor/hood is also advisable. This can be maintained by the end user and cleaned periodically (between procedures) by swabbing with 70% alcohol solution. This is especially indicated if the patient is coughing.
All personnel should be trained in the proper donning and doffing of PPE. Gloves should be changed in between patients and hand hygiene performed in between. Glove decontamination with sanitiser is essential before discarding them. In case there is contact with potentially infected patients, N95 masks are recommended in addition to the equipment mentioned above.
We would again stress that more important than the availability of PPE is the training with regard to the proper usage of PPE.
It is essential that the patient use a face mask (triple layer) at all times and be trained in the steps of hand hygiene. The patient should also be educated about the facts of COVID-19 and be advised to maintain personal cleanliness and social distancing.
| Biomedical Waste Management|| |
All BW should be properly segregated and discarded according to GOI BW management guidelines. All BW should be segregated at source and disposed off in accordance with guidelines. Staff and operators of equipment should be aware and trained for the same.
| Conclusions|| |
NIBS are feasible even during the COVID-19 pandemic. The guidelines as mentioned above can be kept in mind when planning for these services in non-COVID outpatient settings.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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