Purpose
The purpose of the practical training is to ensure TMS Operators understand how to deliver TMS safely according to the VERIFY TMS protocol. Datasets will be collected from healthy volunteers and uploaded onto REDCap, and a member of the VERIFY team will review the datasets to check several aspects such as:
- Were the electrodes placed in the right locations?
- Was the TMS protocol followed correctly?
- Were there any noise issues with the EMG?
- Are MEPs identified correctly?
- Do the answers on the source document match what’s present in the TMS dataset?
You will receive feedback via email regarding each TMS dataset uploaded, and whether they are approved or not.
TMS Operators will receive an email from the VERIFY team once they are given clearance to begin practical TMS training with healthy volunteers. In order to receive clearance to begin practical TMS training you need to be certified on the following six TMS training modules:
- TMS Overview
- TMS Safety Checklist
- EMG Technique
- VERIFY TMS Protocol
- Simple MEP Identification
- Challenging MEP Identification
Sites also need to have their CTA fully executed, cIRB approval received, and investigator agreement forms completed by PI & sub-I(s) and uploaded to WebDCU before TMS Operators at the site can begin practical TMS training with healthy volunteers.
Videos demonstrating practical aspects of EMG preparation and TMS administration can be found on the EMG and TMS Training Videos page.
Protocol
The practical training involves performing the VERIFY TMS protocol with healthy volunteers. This includes all steps from completing the TMS safety checklist to determining MEP status. TMS Operators doing practical training with healthy volunteers require a TMS Assistant to be present during the session.
The TMS source document for healthy volunteers can be found here. The source document should printed out and completed during the TMS session for all TMS sessions with healthy volunteers.
Please read the following link for how to complete the TMS source document.
A one-page document detailing EMG troubleshooting techniques which is useful to have with you during TMS testing can be found here.
Please ensure that all healthy volunteers have signed a consent form which can be done via e-consent. Instructions for the e-consent process can be downloaded from here. All healthy volunteers must also complete the TMS Safety Checklist before receiving TMS.
There is no need to check with a clinician prior to performing TMS with healthy volunteers because they are not medically vulnerable. Training with healthy volunteers also does not require monitoring the participant for 30 minutes after the test is complete.
Practice stimulating both the left and right hemispheres to ensure you are comfortable holding the TMS coil in both positions.
Operators may need additional practice sessions prior to uploading data to familiarize themselves with EMG and TMS, and the specific requirements of the VERIFY TMS Protocol.
A healthy volunteer can complete more than one TMS test in a given day for separate TMS Operators. However, it is important that each test starts from the beginning, with skin preparation and placement of EMG electrodes, to ensure that TMS Operators are practicing the complete protocol. The same electrodes cannot be used for multiple datasets.
Once MEP status for a healthy volunteer has been determined as per the VERIFY protocol it is highly recommended to practice stimulating the participant a few times at 100% MSO while they perform bilateral facilitation. MEPs can typically be elicited from healthy participants at 30-60% intensity, but many stroke patients will require 100% intensity which can be quite startling for both the TMS Operator and participant so it’s good to get some experience with it. Similarly, it’s also good to practice getting the participant to bilaterally facilitate because this is also something you’re unlikely to need to do with healthy volunteers but is very important to do with stroke patients.
Uploading Data
Data from healthy volunteers is uploaded to REDCap rather than WedDCU. Instructions for how to upload data onto REDCap can be downloaded here.
We recommend TMS Operators upload one healthy volunteer dataset at a time and receive feedback from the VERIFY TMS team before performing the next TMS session. This is because if there are issues with one uploaded dataset they will likely be present in the other uploaded datasets, which may result in several datasets not being approved for the same reason.
The following information and documents need to be uploaded to REDcap for each healthy volunteer dataset to enable a quality check:
- The data from the source document should be entered.
- The EMG file containing all the TMS traces. This should contain all TMS traces recorded during the session, and the intensity of each stimulus needs to be included.
- A picture of the ECR, FDI, and ground electrode/strap placement on the healthy volunteer. Take a picture of the volunteer’s arm without getting their face in the photo.
Standard track sites
- TMS Operators will need to practice collecting good quality EMG signals and delivering TMS with healthy volunteers.
- Each TMS Operator will need 5 datasets that are approved by the VERIFY Team. This will involve TMS Operators collecting and uploading datasets from healthy volunteers onto REDCap.
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- Each dataset will be quality checked by the VERIFY team before feedback about each dataset is sent via email as well as whether the datasets are approved or not.
- The same healthy volunteer can be assessed on different days for separate datasets but you must submit data from at least 2 and preferably 3 unique healthy volunteers.
- At least one of these datasets must be submitted and approved after the in-person technique check which is described below.
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- All TMS Operators at standard track sites will require an in-person TMS technique check from a TMS expert, and further details can be found below and here.
Fast track sites
- Each TMS Operator will need 2 datasets from different healthy volunteers that are approved by the VERIFY Team. This will involve TMS Operators collecting and uploading datasets from healthy volunteers onto REDCap.
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- Each dataset will be quality checked by the VERIFY team before feedback about each dataset is sent via email as well as whether the datasets are approved or not.
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- Once a TMS Operator has 2 approved datasets they will require a TMS technique check with the site’s TMS expert present in-person and a member of the VERIFY team present virtually.
- Further details about the technique check at fast track sites can be found here.
Technique Check for Standard Track Sites
Each TMS Operator at standard track sites that are not yet recruiting will need to complete an in-person TMS technique check once they have at least 3 datasets from healthy volunteers approved by the VERIFY TMS Core. The TMS technique check is done to ensure the protocol is being performed safely and correctly. The TMS technique check will likely involve a TMS expert visiting your site and being present for a TMS session with a healthy volunteer. Further details of the TMS Technique visit for standard sites and what will be checked can be downloaded here.
Once each TMS Operator at a site has 3 approved dataset the VERIFY team will be in contact with the site to begin scheduling when a TMS expert can visit your site to do a TMS technique check. Ideally the TMS Technique check will only be done once all your site’s TMS Operators have completed their practical training. TMS Operators will need to organize a consented healthy volunteer for the TMS technique check. Once you have completed the in-person technique check you will need another 1 or 2 approved datasets depending on how many you had approved prior to the technique check.
For sites that are already activated and recruiting, any new TMSO will instead perform a virtual TMS technique with a member of the VERIFY TMS Core present via a videocall rather than an in-person technique check. The content and process of virtual technique checks is the same as in-person technique checks.
Technique Check for Fast Track Sites
Each TMS Operator at fast track sites will need to complete a virtual TMS technique check after they have 2 datasets from healthy volunteers approved by the VERIFY TMS Core. The TMS technique check is done to ensure the protocol is being performed safely and correctly. The TMS technique check will involve a member of the VERIFY TMS Core being present over videocall for a TMS session with a healthy volunteer. Further details of the TMS Technique visit for fast track sites and what will be checked can be downloaded here.
Once a TMS Operator at a site has 2 approved datasets then the VERIFY team will be in contact with the site to begin scheduling when a member of the VERIFY TMS Core can be present during one of their TMS sessions with a healthy volunteer. This will likely have to be in the afternoon in the US due to the time difference between the US and New Zealand where the VERIFY TMS Core is located. TMS Operators will need to organize a consented healthy volunteer for the TMS technique check.
Visit TMS with VERIFY Stroke Patients for specific information about doing TMS with VERIFY stroke patients that you would be unlikely to encounter with healthy volunteers.
Resources
TMS Source Document for Stroke Patients
TMS Source Document for Healthy Volunteers
TMS Technique Check Form for Standard Sites
TMS Technique Check Form for Fast Track Sites
Reimbursements
Healthy volunteers are paid $25 per session, up to $100 for an individual.
Each site has up to $1000 to reimburse healthy volunteers.
If you have any questions about the practical TMS training then please email us on verify.study.tms@gmail.com.
If you require urgent assistance or advice during a TMS session please call or text the TMS hotline at: (833)337-2227 (Available Mon-Fri 8am-9pm ET)