#180373
Click here to view a PDF of the IRB approved consent form
UNIVERSITY OF CALIFORNIA - SAN DIEGO (UCSD)
CONSENT TO PARTICIPATE IN ONLINE SCREENING
Measuring Human Brain Activity during repetitive Transcranial Magnetic Stimulation in healthy participants
Dr. Scott Makeig and colleagues are conducting a research study to find out how brief magnetic brain stimulation (applied to the scalp) changes electrical brain activity. Healthy volunteers between 23 and 60 years of age will participate in the study. We will apply ‘transcranial magnetic stimulation’ (TMS) to one scalp area while recording EEG (brainwave) activity from the scalp plus ECG (heartbeat) activity from the chest, and EMG (muscle) activity from the hand. Participants will perform some simple computerized tests of behavioral control and will fill out some questionnaires. You have been asked to participate because you have expressed interest in this study. There will be 270 participants in the study between March, 2018 and March, 2020. The study will take place at the UCSD PrTMS Research Center, 16918 Dove Canyon Rd #100, San Diego, CA 92127.
Aim of the study:
We want to find out how stimulating the brain with magnetic pulses can influence behavior such as movements or your concentration such as attention. We also want to study how these changes in behavior or attention are related to changes in brain activity. We will measure electric activity in your brain by connecting small electrodes to the surface of your head using water-based gel. By measuring changes in brain activity during simple behaviors we can learn more about how magnetic stimulation may changes the relationship between brain activity and behavior. Before you can participate in this study you must fill out a safety screening questionnaire and permit us to contact you for an in-person interview.
If you agree to take part in this screening, you will be asked to complete an online
survey/questionnaire. This survey/questionnaire will ask about some of your medical history
and it will take you approximately 2 minutes to complete. If you do not meet screening criteria,
your data will be discarded. If, after submitting your answers, you meet screening criteria, we
will ask for your name and contact information in order to reach out for an in-office screening.
If you agree to participate in the online screening, click YES below. If you do not want to
proceed to the safety questionnaire, and you do not wish to participate in the online screening,
please click NO.
We will only collect your contact information if you consent to participate in the online safety
screening AND if you pass the safety screening.
If you pass the safety screening, you will be prompted to provide your email and/or phone
number. A member of the research team will then contact you by email in the following days to
schedule an appointment for the study.
There may not be any direct benefit to you from this research. The investigator(s), however,
may learn more about repetitive TMS.
There are minimal risks associated with this research study. These include risk that information
about the identity of the subjects may be compromised. Research records will be kept
confidential to the extent allowed by law and may be reviewed by the UCSD Institutional
Review Board. Subjects’ personal, identifiable information will be completely removed from any
data associated with the individual. Questionnaire, behavioral and EEG data will be assigned a
coded number. The identifiable information is only accessible by a restricted number of UCSD
personnel at the Center for Neuromodulation who has access to the key of the coding system.
All identifiable information will be completely removed from data received by the PI and project
associates at SCCN, UCSD.
Your participation in this study is completely voluntary and you can withdraw at any time by
simply exiting the survey. Choosing not to participate or withdrawing will result in no penalty or
loss of benefits to which you are entitled. You are free to skip any question that you choose.
If you have questions about this project or if you have a research-related problem, you may
contact the researcher(s), Johanna Wagner (j9wagner@ucsd.edu) and Susana Brugues (858-
249-2637). If you have any questions concerning your rights as a research subject, you may
contact the UCSD Human Research Protections Program Office at 858-246-HRPP (858-246-
4777).
By clicking “Yes” below you are indicating that you are at least 18 years old, have read this
consent form, and agree to participate in this research study. Please print a copy of this page
for your records.