COVID-19 Brain Health Study Questions

It is important to note that the results from this study will not be available to you. The images and other data for this study are being collected for research purposes only.

The MRI scan being done is designed to answer research questions, not examine your brain medically. This MRI scan is not a substitute for one a doctor would order. It may not show problems that would be picked up by a medical MRI scan. However, if we believe that we have found a medical problem in your MRI scan, we will contact you and, with your permission, contact your family physician and help him or her get the right follow-up for you. No information generated in this study will become part of your record routinely. However, if the study detects an abnormality in your MRI scan and further follow-up is required, then this information may become part of your record.

There are some risks in undergoing an MRI:

• The magnetic effect of the MRI on implanted devices. The MRI could cause any metal in your body to heat up. This is because the MRI machine uses strong magnets in order to collect the scans. Every effort will be made to eliminate this risk, by asking you ahead of time about any devices or injuries from metal objects, and not running the test if you have anything in your body that will be affected by the machine.
• The brain MRI is a magnetic resonance imaging procedure to take images of your brain. This MRI procedure will have you lie on your back on a narrow table that will be moved into a circular tube. You will not be able to see outside of the tube. There will be repetitive thumping noises as the MRI scans your brain. It will take approximately 45 minutes to complete the scans.

These discomforts will be mitigated in the following ways:

• Headphones and ear plugs will be worn for ear protection.
• Tingling sensations sometimes occur in the arms, but these can usually be prevented by keeping the hands apart.
• The technician will maintain visual and verbal contact with you throughout the MRI scanning sessions.
• As an extra precaution, you will be given an “emergency” button to be used if you wish to end the procedure.
• It is important to understand that participation in the MRI scans will require travel outside your home. The MRI facilities and CLSA staff will follow the required protocols for working safely during the pandemic.

You will be asked to repeat this data collection in two years.

The CLSA COVID-19 Brain Health Study is funded by the Canadian Institutes of Health Research and the Weston Family Foundation.

Participants in the CLSA COVID-19 Brain Study:

• Complete one 45-minute telephone interview; and,
• Come into a clinic to get a one-hour magnetic resonance image (MRI) taken of the brain at a clinic associated with the CLSA Data Collection Site (DCS) nearest to you.

The MRI and the short telephone interview will be repeated two years later for all participants, and one and two years later for a small subset of participants. These MRIs and other data will become part of the CLSA dataset and will allow researchers to specifically look at the direct and indirect effects of COVID-19 on the brain.

There are no direct benefits to you for participating in the study. Your participation in the CLSA COVID-19 Brain Study will contribute to increasing our understanding of the effects of COVID-19 on cognitive and neural health. A better understanding is critical to the identification of those at risk and timely deployment of therapeutic approaches to mitigate the cognitive and neural consequences of the COVID-19 pandemic.

Your participation in this research study will not involve any costs to you except the time that it takes you to take part completing the MRI appointment. You will be given $30 at your visit to put toward expenses such as parking or other travel-related expenses.

You should not have an MRI if you have any of the following items implanted in your body:

• Cardiac pacemaker, wires, or a defibrillator
• Metal fragment in the eye or orbit
• Brain aneurysm clip
• Stainless steel Intrauterine Device (IUD)
• Artificial heart valve
• Eye or ear implant
• Implanted drug infusion pump
• Shunt
• Electrical stimulator for nerves or bones
• Coil, catheter or filter in any blood vessel
• Orthopedic hardware (artificial joint, plate, screws, rods)
• Other metallic prosthesis
• Shrapnel, bullets, or other metallic fragments
• Stent
• Shunt

Participants who have any of the implants listed above cannot participate in the study.

You should also not have an MRI if you are pregnant or suffer from claustrophobia, or if a doctor has ever told you that you have experienced a stroke or CVA (cerebrovascular accident) or a ministroke or TIA (transient ischemic attack).

Recruitment is now complete.

The data collected are de-identified (meaning the data are connected to an ID number, not to your name or any other personal identifying information). The MRI scans are labelled with this ID (not with your name) at the MRI facility and then the images are sent to Calgary Image Processing and Analysis Centre (CIPAC) at the University of Calgary for review and long-term storage. The data associated with the scans, like all CLSA data, are kept on secure servers located at McMaster University.

No identifiable information will be shared with anyone outside of our stablished CLSA protocols. The CLSA will protect any information and images collected as we do for all other CLSA participant information.

Your agreement to participate in the CLSA COVID-19 Brain Study is entirely voluntary. Your decision to participate does not affect your participation in the CLSA study that you have participated since 2012-2015.

Please know that you can always contact us with any questions by emailing us at cogmob.research@hiphealth.ca or by telephone at 1-866-999-8303.