RPS: Spalek Lab TMS Study
Thank you for your interest in participating in our experiment! If you navigated to this page from SFU's Research Participation System (RPS), or if you are a student or community member looking to participate in our experiments, you are in the right place.
On this page you can find the informed consent form for the RPS study titled "SpalekLab TMS" (Initial stages of visual perception). This study has 3 parts, and each part is conducted on a separate day. This consent form is for all 3 parts of the study. Please read the consent form carefully before Part 1 of the study. Please note that you do not need to sign this form before the Part 1 session.
You may download a pdf copy of the consent form to keep for your records if you wish, but this optional.
Initial Stages of Visual Perception Consent Form
Principal Investigator: Dr. Thomas Spalek
Collaborators: Dr. Vincent Di Lollo, Nadja Jankovic, MA Psychology
PRINCIPAL INVESTIGATOR: Dr. Thomas Spalek, Professor, Department of Psychology, Attention, Memory, & Perception Labs, Simon Fraser University, tspalek @ sfu . ca, 778 782 3105
COLLABORATORS: Dr. Vincent Di Lollo, Professor Emeritus, Department of Psychology, Attention, Memory, & Perception Labs, Simon Fraser University, enzo @ sfu . ca, 778 782 7055; Nadja Jankovic, MA Psychology, Department of Psychology, Simon Fraser University, njankovi @ sfu . ca, 778 782 5359
You are being invited to take part in this research study because you have answered our advertisement and are between the ages of 18 and 35 years, with normal or corrected to normal vision, and without any pre-existing neurological conditions or history of traumatic brain injury. The results of this study will provide valuable information on how the human brain perceives and recognizes objects.
When we say “you” or “your” in this consent form, we mean the research participant; “we” means the principal investigator, co-investigator(s), and other research staff.
Participation is Voluntary: You do not have to participate in this research study. It is important that before you make a decision to participate, you read the rest of this form. Please read the following form carefully and ask questions if anything is not clear. This consent form will tell you about the study, why the research is being done, what will happen during the study and the possible risks, benefits, and discomforts.
If you wish to participate, you will be asked to sign this form. If you do decide that you would like to participate, you are still free to withdraw from the study at any time and without giving any reasons for your decision. If you do not wish to participate, you do not have to provide any reason for the decision, and you will not be penalized in any way.
Please take time to read the following information carefully.
While we have learned a lot about the brain so far, very little is known about some basic cognitive functions. For example, the process of recognizing your car probably seems automatic. However, there are many complex brain processes involved in object perception which we do not fully understand yet. From the moment that light enters your eyes to the moment you recognize an object, your brain processes different aspects of the visual information at different points in time. In the past, it was thought that different brain areas worked separately to process only one aspect of visual information, such as contours or colour. However, evidence suggests that the same brain area may take part in processing different aspects of the image at multiple points in time.
The main goal of this research is to gain insight into how your brain’s visual areas communicate during the different stages of object processing. By disrupting the processing at different points in time, we will gather valuable information about the timing and order of these processes and about the potential brain networks involved in object perception.
WHO CAN PARTICIPATE IN THIS STUDY?
You may be eligible to participate in this study if you meet the following criteria:
- You are between the ages of 18 and 35
- You have normal vision, or your vision is corrected-to-normal using contact lenses
WHO SHOULD NOT PARTICIPATE IN THIS STUDY?
If any of the following conditions apply to you, you are at an increased risk while undergoing transcranial magnetic stimulation (TMS). You should not participate in this study if:
- You have had at least one seizure in the past, or you have a family history of epilepsy
- You have a history of a neurological condition, psychiatric condition, or traumatic brain injury
- You require eye glasses and do not use contact lenses
- You are pregnant, or think you may be pregnant
- You suffer from a chronic sleep disorder
- You have a history of fainting spells
- You suffer from a substance dependence, including excessive alcohol consumption or drug use. A substance dependence may put you at a higher risk for having a seizure while undergoing TMS.
- You suffer from tinnitus (i.e., ringing in the ears)
- You have been diagnosed with Autism
- You have a movement disorder or tremor
- You are currently taking, or have taken in the last 6 weeks, medications in the following categories:
· Chemotherapy medications
If any of the following conditions apply to you, you may not be eligible to participate in the MRI portion of the study. However, you may still be eligible to participate in other aspects of this research, such as the TMS session.
- You are uncomfortable in small, tight, enclosed spaces (i.e., you suffer from claustrophobia)
- You have any implants in your body, such as:
· copper intrauterine device (IUD)
· brain aneurysm clip
· cochlear implant
· electrical stimulator for nerves or bones
· implanted infusion pump
· history of any eye injury involving metal fragments
· you have been a metal worker (grinding, machining, or welding)
· artificial heart valve
· orthopedic hardware (artificial joint, plate, screws, rods)
· other metallic prostheses
· stent, coil, catheter of filter in any blood vessel
· ear or eye implant
· shrapnel, bullets, or other metallic fragments
· medication releasing skin patches (nicotine, birth control, nitroglycerine)
- You have had surgery or a tattoo within the past 6 weeks
If you agree to take part in the study, Dr. Spalek and associates will determine if you meet all relevant conditions to be included in the study. This will be completed with a screening interview, where you will be asked questions about your medical history. Screening should take no more than 15 minutes.
WHAT DOES THE STUDY INVOLVE (PROCEDURES)?
If you are eligible and you decide to participate in this study, you will undergo up to 2 sessions: in one session you will undergo a structural magnetic resonance imaging (MRI) scan (if eligible), and in the other session you will be tested on object perception while receiving single or paired pulse transcranial magnetic stimulation (TMS). The MRI and the TMS sessions will not be performed in the same locations and will occur on separate days. The total duration of your participation in this study will not exceed 2 hours and 45 minutes.
Your eligibility for both the MRI and the TMS will first be assessed during a screening interview, which will take approximately 15 minutes.
If you are eligible for MRI, you will then undergo a 3T Magnetic Resonance Imaging (MRI) scan at the SFU ImageTech Laboratory in Surrey Memorial Hospital. Prior to your scan, you will again be screened for eligibility by the imaging personnel. The MRI scan will last about 5 to 10 minutes and the MRI session will last a total of 30 minutes, including screening and set up. The MRI scanner uses a large magnetic field to non-invasively take pictures of your brain.
You will then undergo a transcranial magnetic stimulation (TMS) experimental session at the Spalek Perception Laboratory at Simon Fraser University’s Burnaby campus. The TMS session will last approximately 120 minutes. As some time may have passed since the screening interview, we will assess safety and risk concerns with a brief screening questionnaire before starting TMS stimulation. If eligible, we will then determine the strength of stimulation that we will use by determining either your “phosphene threshold” by applying TMS to the visual areas of the brain, or your “motor threshold” by applying TMS to the motor areas of the brain.
Phosphene Threshold: Phosphenes are small patches of light in your vision, similar to what you see when you close your eyes and press on your eyelid. Some participants may find it difficult to recognize phosphenes, so a brief training procedure may be used. The stimulation intensity is set at a relatively high intensity for the training procedure to maximize the chance of seeing phosphenes. To find your “phosphene hotspot” (i.e., the brain location that elicits the strongest phosphenes) the stimulation intensity will be decreased to a moderate intensity. Then, to determine your “phosphene threshold”, the stimulation intensity will be decreased to a relatively low intensity. The stimulation intensity will slowly increase until you report seeing 5 phosphenes out of 10 TMS pulses.
Motor Threshold: Electromyography (EMG) electrode pads will be placed on your finger to measure muscle activity. First, it is necessary to find your “motor hotspot” (i.e., the brain location that produces the strongest finger muscle activity). The stimulation intensity will start low, and gradually increase. Next, the stimulation intensity will be gradually lowered, and your “motor threshold” will be determined. Motor threshold is defined as the stimulation intensity needed to produce 5 muscle activations out of 10 TMS pulses.
After we determine the stimulation intensity, you will be shown images on a computer screen while receiving single or paired pulse TMS. In addition to receiving stimulation to the target brain area, you will also receive “sham” TMS, where stimulation will be applied to another brain area that is not involved in the task. You will respond to the images by pressing keys on a keypad. You should not feel alarmed if you find it hard to respond correctly to some of the images. This effect is expected and is short-lasting.
WHAT ARE POSSIBLE HARMS AND SIDE-EFFECTS OF PARTICIPATION?
There are some potential discomforts and risks to your health and well-being if you agree to be a participant in this research. These procedures will be conducted by Dr. Spalek or his associates who have completed procedural and safety training according to published safety guidelines. Dr. Spalek or his associates have discussed this research with you and have described them as follows:
The adhesive pads used for the EMG test may cause skin irritation or redness. In addition, the alcohol wipes used to clean the skin area for EMG electrodes may cause irritation.
Computerized Visual Perception Task:
This task is considered minimal risk, meaning there is no known risk that is greater than what you would expect in normal, daily life. You will be looking at a computer screen, which may cause eye strain. You will also be sitting in a chair for up to one hour, which may cause back and/or leg discomfort for some participants.
There is very little known risk associated with undergoing an MRI scan. MRI is used routinely in hospitals around the world. A small number of people may find lying still inside the MR scanner uncomfortable and stressful. If this occurs, then you will be brought out of the scanner and the scan stopped. Some people are also uncomfortable being in small places (i.e., claustrophobia). Because the MRI scanner is a small space you may also be uncomfortable lying inside it. If you do feel this way you will be brought out of the scanner and the scan will be halted. The MRI also makes loud noises that you may find uncomfortable, but we will use ear plugs to protect your hearing. You will not be able to participate in the MRI component of this study if you have any metal or surgical implants that may be affected by the strong magnetic fields used in the MRI process or may cause tissue damage associated with dislodging the metal and/or for the objects to become heated during the scan and cause a burn. Most implants are not affected by MRI, but if but if any of the MRI exclusion criteria listed above apply to you, you will not be able to participate in the MRI component of this study.
Single or paired pulse TMS is considered a safe, non-invasive way to temporarily and reversibly change brain activity. Safety standards for the application of TMS have been developed and will be followed by trained operators during this study to minimize the risk. In accordance with these standards, the TMS machine will always be run at a rate and a frequency that are known to be safe.
A member of the study team has discussed this research with you and has described the risks as follows:
· There has never been a report of a seizure associated with the type of TMS you will receive in this study (i.e., single-pulse or paired-pulse TMS) in healthy participants. There is a potential risk of provoking a seizure in people with a history of seizures (e.g., epilepsy) or conditions known to increase seizure risk (e.g., traumatic brain injury, substance dependence). You will not be eligible to participate in this study if you have such history and/or conditions.
· Although it is rare, there is a risk of fainting during TMS. This is thought to occur due to anxiety. Throughout the TMS session, you will be monitored for any signs of fainting. If you feel that you may faint, the TMS session will be stopped immediately and you will be assisted. If you have a history of fainting spells, you will not be eligible to participate in this study.
· There is a risk of headache, scalp pain, toothache or scalp numbness associated with single and paired pulse TMS. Neck stiffness may also occur, which is thought to be due to holding your head still for a long period of time. Each of these side effects are transient (i.e., does not last).
· The clicks associated with TMS are loud and could potentially damage your hearing. To minimize this risk, you will be asked to wear earplugs throughout the testing session.
Although TMS has been performed in laboratories all over the world since 1985, there may be short- and long-term effects that have not yet been identified, and unexpected side effects that have not been previously observed may occur.
WHAT ARE THE BENEFITS TO YOU PARTICIPATING IN THE STUDY?
There is no direct benefit to you for participating in this study. However, it is hoped that the findings from this study will fill gaps in our knowledge and expand our understanding of how the human brain processes important visual information. You will be informed if any significant new findings develop during the course of the study that may affect your willingness to participate in this study.
A potential risk of participating in this study is the discovery of incidental findings, such as brain abnormalities, during the MRI session. As this will NOT be a medically indicated examination, there will be no formal review of the scans and no report. 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 ask a doctor who is trained in the reading of MRI scans, a radiologist, to help us review the scan. If the radiologist thinks that there may be an abnormality in your MRI scan, we will, with your permission, contact you and inform you of the abnormality. 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. If you do not wish to be informed of incidental findings on your MRI scan, you will not be able to participate in the MRI portion of this study.
Would you like to be notified if an abnormality is detected on your MRI scan? Please check one:
___ YES ___ NO
COMPENSATION TO PARTICIPANTS
Depending on your situation, you may be compensated monetarily or with course credit, or both.
If you are eligible to receive Research Participation System (RPS) credits, you will receive 1 credit for each half-hour, up to a maximum of 6 credits. In addition, or in lieu of RPS credits, you may receive monetary compensation in line with hourly minimum wage for your participation time.
WITHDRAWING FROM THE STUDY
You may withdraw from this study at any time without giving reasons. If you choose to enter the study and then decide to withdraw at a later time, you have the right to request the withdrawal of your information collected during the study. This request will be respected to the extent possible. Please note however that there may be exceptions where the data will not be able to be withdrawn, for example where the data is no longer identifiable (meaning it cannot be linked in any way back to your identity) or where the data has been merged with other data. If you want to cancel your enrollment in this study, you can indicate this verbally or send a request via email to Dr. Spalek at firstname.lastname@example.org. If your participation in this study includes enrolling in any optional studies, you will be asked whether you wish to withdraw from those as well.
CAN I BE ASKED TO LEAVE THE STUDY?
If you are not able to follow the requirements of the study for any other reason, the researcher may withdraw you from the study. On receiving new information related to the study, your researcher might consider it to be in your best interests to withdraw you from the study without your consent if they judge that it would be better for your health and safety. If you are asked to leave the study, the reasons for this will be explained to you and you will have the opportunity to ask questions about this decision.
Your confidentiality will be respected. No information or records that disclose your identity will be published without your consent, nor will any information or records that disclose your identity be removed or released without your consent unless required by law.
You will be assigned a unique study number as a participant in this study. Only this number will be used on any research-related information collected about you during the course of this study, so that your identity [i.e., your name or any other information that could identify you] as a participant in this study will be kept confidential. Information that contains your identity will remain only with the Principal Investigator and/or designate. The list that matches your name to the unique study number that is used on your research-related information will not be removed or released without your consent unless required by law. All data will be stored for 2 years in accordance with SFU regulation. Any paper forms (e.g., screening questionnaires) will be destroyed after 2 years.
Your rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is respected and also give you the right of access to the information about you that has been provided to the sponsor and, if need be, an opportunity to correct any errors in this information. Further details about these laws are available on request to your study researcher.
You have read the information in this form. Dr. Spalek or his associates have answered your question(s) to your satisfaction. You are aware that if you have any more questions after signing this form you may contact Dr. Spalek or one of his associates by email at tspalek @ sfu . ca. If you have any questions about your rights as a research participant, you may call the Director of the SFU Office of Research Ethics at 778-782-6593 or by email at email@example.com.
TITLE: Initial Stages of Visual Processing
Dr. Spalek (or his associates) have given you information about this research study.
They have explained what will be done and how long it will take. They explained any inconvenience, discomfort or risks that may be experienced during this study.
My signature on this consent form means:
· I have read and understood the participant information and consent form.
· I have had sufficient time to consider the information provided and to ask for advice if necessary.
· I have had the opportunity to ask questions and have had satisfactory responses to my questions.
· I understand that all of the information collected will be kept confidential and that the results will only be used for scientific objectives.
· I understand that my participation in this study is voluntary and that I am completely free to refuse to participate or to withdraw from this study at any time without being penalized in any way.
· I understand that I am not waiving any of my legal rights as a result of signing this consent form.
· I understand that there is no guarantee that this study will provide any benefits to me.
I freely and voluntarily consent to participate in this research study. The investigator is satisfied that the information contained in this consent form was explained, that all questions have been answered, and that the participant assents to participating in the research.
I will be given a signed and dated copy of the consent form to keep for my records.
Type/Print Participant's Name
Signature of Participant Date
Type/Print Name of Person Obtaining Consent
Signature of Person Obtaining Consent Date
Future studies: You may be invited to take part in future studies. If Dr. Spalek thinks you might qualify for another study by him or his colleagues, he will contact you directly by email or telephone and ask if you are interested. There will be no impact on you if you choose not to take part. You are NOT giving permission to do any future studies in this consent form.
Are you willing to be contacted in the future about participation in future studies? Please check one:
___ YES ___ NO
Any questions may be directed to: Nadja Jankovic (nadja_jankovic @ sfu . ca)
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