Purpose
To provide information and rationale for completing the VERIFY TMS Safety Checklist in consultation with the patient, their family, and the patient’s clinical notes.
Overview
It is important to screen patients for contraindications before TMS testing. The TMS safety checklist is used to ensure VERIFY patients are safe to receive TMS, and to minimize the potential for side effects during TMS. Screening is done by completing the TMS Safety Checklist by talking with the patient and their family, and reviewing the patient’s clinical notes. A physician, physician’s assistant, or nurse practitioner of the patient’s care team should be contacted on the day of the test to check that it’s still appropriate to go ahead with the test. The safety checklist can be started as soon as the patient is consented to the VERIFY study.
The VERIFY TMS Safety Checklist can only be completed with stroke patients by a trained VERIFY staff member who has received a certificate for completing the TMS Safety Checklist module. This requires passing the practice and final quizzes at the bottom of this page.
The TMS Safety Checklist is based on the 2021 guidelines from the International Federation of Clinical Neurophysiology.
Absolute contraindications
The VERIFY TMS safety checklist has 13 questions about absolute contraindications. If the answer to any of these questions is YES then TMS is contraindicated for the patient and TMS testing cannot go ahead. The questions are provided below with brief explanations of why a YES answer means TMS is contraindicated. More detailed information is provided in the following section.
TMS can interfere with the function of implanted electronic devices. The first 5 questions relate to stimulators that could be affected by TMS and therefore stroke patients with any of the following devices cannot receive TMS
- Does the patient have a cardiac pacemaker?
- Does the patient have a cochlear implant?
- Does the patient have a deep brain stimulator?
- Does the patient have a vagus nerve stimulator?
- Does the patient have a cervical spine epidural stimulator?
The next two questions relate to intracranial implants as these might also be affected by TMS.
- Does the patient have a ventriculoperitoneal shunt?
- Does the patient have ferromagnetic intracranial metallic implants?
Note that metallic implants such as stents are acceptable provided they are not ferromagnetic.
The next two questions ask about more serious brain injury relating to the patient’s current stroke that could increase the risk of a TMS-induced seizure.
- Does the patient have a skull defect related to the current stroke?
- Has the patient had seizures since onset of the current stroke?
TMS is contraindicated for people who take anti-epilepsy medication but experience break-through seizures.
- Has the patient had a seizure in the last 12 months while taking anti-epilepsy medication?
TMS is contraindicated for people who are pregnant.
- Is the patient pregnant?
- As an additional safety precaution people who are pregnant cannot be a TMS Operator for VERIFY but they can be the TMS assistant as long as the TMS coil is not activated within 3 feet of the pregnant person’s torso.
TMS is contraindicated for people who have previously had a serious adverse reaction to it, such as a seizure, as it may happen again in response to TMS.
- Has the patient had a previous serious adverse reaction to TMS?
Further information
This section addresses common questions about contraindications to TMS.
The patient has an electronic device in their body that isn’t on the contraindications list. Is TMS safe?
TMS is NOT safe for people with electronic devices anywhere in the body if the device is at or above the level of the seventh cervical vertebra.
TMS is safe for people with electronic devices anywhere in the body if the device is below the level of the seventh cervical vertebra, including:
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- Medication pumps
- Glucose monitoring devices
- Epidural spinal cord stimulators
- Gastric pacemakers
The patient has some metal in their body that isn’t on the contraindications list. Is TMS safe?
TMS is allowed for people with metallic implants in their brain, such as stents and aneurysm clips, provided the implants are not ferromagnetic. If the patient has had an MRI scan of their brain after the implants were put in, then the implants are not ferromagnetic, and TMS is safe.
TMS is allowed for people with metallic implants in their head but not their brain, including:
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- Dental fillings, crowns, and implants, and orthodontic braces
- Titanium and stainless steel plates, screws, and wires in the bones of their skull, cervical spine, and upper and lower jaw
- Piercings in the ears, nose, lips, eyebrows, and tongue
- Tattoos with metallic inks including permanent make-up
TMS is allowed for people with metal anywhere in the body below the seventh cervical vertebra, including:
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- Artificial joints and heart valves
- Plates, screws, and wires in any bones
- Bullets and shrapnel
- Piercings and tattoos with metallic inks
The patient has a history of seizures or epilepsy. Is TMS safe?
TMS-induced seizures are very rare and especially so when using single-pulse TMS. TMS is very low risk for people who have had seizures or have been diagnosed with epilepsy. It is also very low risk for people with stroke. The risk of a TMS-induced seizure in people with stroke is estimated at 8/10,000 sessions, or less than 0.1%. This is 50 times lower than the risk of simply having a seizure within 2 weeks of stroke, which is approximately 5%.
TMS is allowed for people with a current diagnosis of seizures or epilepsy, provided they are currently taking anti-epilepsy medication if it has been prescribed to them, and they have had no seizures in the past 12 months.
TMS is allowed for people with a historical diagnosis of seizures or epilepsy who are not currently taking anti-epilepsy medication provided they have not had any seizures in the past 12 months.
Resources
Frequently asked questions
How is the information for the TMS Safety Checklist collected?
A TMS Safety Checklist is completed by a trained VERIFY staff member in consultation with the patient, their family, and a review of the patient’s clinical notes. Obtaining information from all these sources reduces the risk of missing essential information. A staff member is considered trained when they have received a certificate for completing the TMS Safety Checklist module.
Who can confirm the patient is appropriate for TMS testing?
The checklist can be completed by a member of the VERIFY study team at your site. They will need to sign it to confirm that the answers are correct. If the patient has no contraindications then the TMS test can be scheduled. The TMS Operator or Site Coordinator needs to contact a physician, physician’s assistant, or nurse practitioner who is part of the patient’s care team on the day of the TMS test to find out whether there have been any changes to the patient’s status that could mean the test should be delayed. This is documented on the TMS Source Document.
What happens if the patient’s situation changes between checklist sign-off and TMS testing?
The patient’s status might change due to medical instability or neurological deterioration. If they experience a seizure between completing the checklist and TMS testing then they are now contraindicated for TMS and cannot continue in the study. This is why it’s important to contact a physician, physician’s assistant, or nurse practitioner in the patient’s care team on the day of the test, to check that it’s still appropriate to go ahead with the test. If the patient has no contraindications but their status has changed such that TMS needs to be delayed, the test can be rescheduled provided it can be completed within 72-168 hours of symptom onset or last known well.
What happens if the patient is scheduled for TMS testing but becomes medically unwell on the day of testing?
The TMS session should be rescheduled but still within Hours 72-168 after the index stroke. If the TMS session does get rescheduled then a physician, physician’s assistant, or nurse practitioner who is part of the patient’s medical team should be contacted on the day of the rescheduled session to check that it’s still appropriate to go ahead with the test. Any change of plan should be documented in the patient’s clinical notes and relayed to the relevant ward staff.
If the patient is too unwell and TMS session cannot be rescheduled between Hours 72-168 after the index stroke then the patient should be withdrawn from the VERIFY study unless they have already had their study-specific MRI. If the patient has had their study-specific MRI already they are considered enrolled into VERIFY and should complete all subsequent study assessments but without TMS testing
What if there are disagreements between the clinical notes and what the patient answers?
In this situation try to access and review any previous clinical notes. Make sure to note down the discrepancies and discuss them with the patient’s physician. It can also be useful to go through the TMS safety checklist with the patient when a close friend or family member is present if possible to get confirmation about the patient’s answers.
Quiz
Click here for a practice quiz to assess your learning on TMS Safety Checklists for VERIFY.
Once the practice quiz has been completed with at least 70% correct you will be emailed a link to the final quiz for this module.
If you pass the final quiz with at least 80% correct you will be emailed a certificate of completion for the TMS Safety Checklist module. There is no limit to the number of attempts for the practice or final quiz.
Please email verify.study.tms@gmail.com if you have any questions or comments or require assistance.