Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06050603
Status:
RECRUITING
Last Update Posted:
2023-09-22
First Post:
2023-09-03
Brief Title:
MRI Guided Closed-loop TMS-EEG
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Spatiotemporally Precise Neuromodulation by Transcranial Magnetic Stimulation Guided by Multimodal Neuroimaging
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this interventional study is to develop an individualized approach using transcranial magnetic stimulation TMS in a high-precision manner This approach will use TMS to modulate brain activity at multiple locations simultaneously Functional magnetic resonance imaging fMRI and electroencephalograph EEG will record the responses and guide the stimulation Specifically the placement and orientation of TMS coils will be tailored to stimulate the targeted functional brain areas informed by fMRI To maximize the interventional effect stimulation pulses will be delivered based on EEG oscillations
Detailed Description:
Background
Transcranial magnetic stimulation TMS is a non-invasive technique that uses a transient electromagnetic field over a small area of the scalp to alter neuronal activity It has been approved by Health Canada for the treatment of major depressive disorder and obsessive-compulsive disorder Despite its clinical prevalence TMS has a response rate of less than 50 and high intra- and inter-subject variability Even among healthy subjects the probability of inducing neuro-modulatory effects can be as low as 50
Design
Depending on the studys aims participants will have to visit Sunnybrook Health Sciences Centre two or three times on separate days Participants will be screened with a medical record review before their first visit
In the first visit participants will have a magnetic resonance imaging MRI session During the MRI session participants will be brought inside an MRI scanner to collect images including structural and functional MRI scans During structural scans participants will be asked to stay inside the MRI while images are taken During functional MRI scans participants will be asked to take rests with eyes open watching andor listening to audiovisual stimuli and respond to stimuli by button pressing Before starting MRI scans a short training on the task will be taken An additional assessment and if necessary training sessions will be conducted to ensure that participants undergo imaging while being able to keep their heads sufficiently for acceptable fMRI data quality Before entering the MRI room participants will be asked to remove any metal or magnetic sensitive objects eg jewelry keys credit cards to ensure safety Earplugs or earphones will be provided to participants to reduce the loud noise produced by the MRI scanner During the MRI scans participants will perform the same task as notified in the training session Short breaks will be arranged between tasks The entire MRI procedure will take approximately one hour If electroencephalograph EEG is to be recorded during MRI scans an additional one hour is needed for EEG preparation before the MRI scans After MRI scans participants may be asked to rate their feelings toward the audiovisual stimuli cognitive states and emotional states on a computer
Participants will be asked to attend TMS-MRI experiments twice on separate days for aim 1 In the TMS-MRI session participants will take TMS and MRI separately For TMS participants will be led to a treatment room and seated in a comfortable chair in a slightly reclined position A research staff will place an electromagnetic coil softly against each participants head A TMS coil will painlessly deliver magnetic pulses stimulating nerve cells at predetermined intervals Electrodes may be mounted on the participants wrists and around the eyes to monitor muscle activities The treatment protocol for each participant will be based on hisher MRI scans EEG signals or motor responses This step may be helped by using a camera During TMS participants will hear clicking sounds generated by the TMS coil and may have touching or twitching senses over their faces After TMS participants will be brought to an MRI room for MRI scans as described above A rating of the participants feelings and task performance may be taken after MRI scans
For aims 2 and 3 participants will be asked to attend a TMS-EEG-MRI experiment once In the TMS-EEG-MRI session participants will first undergo TMS and EEG together Then participants will undergo an MRI For TMS-EEG participants will be led to a treatment room and seated in a comfortable chair in a slightly reclined position Each participant will be asked to wear an EEG cap A device is then used to measure the EEG electrode locations over the cap Then conductive gel will be applied to EEG electrodes over the cap Participants may feel skin scratching when the research staffs apply the conductive gel Additional electrodes will be attached around the participants eyes and wrists to monitor muscle movement During TMS a research staff will place an electromagnetic coil softly against the participants head A TMS coil will painlessly deliver magnetic pulses that stimulate nerve cells The investigators will determine the treatment protocol based on each participants MRI scans EEG signals or motor responses This step may be helped by using a camera During TMS participants will hear clicking sounds generated by the TMS coil and may have touching or twitching senses over their faces After TMS participants will be brought to an MRI room for MRI scans as described above A rating of the participants feelings and task performance may be taken after MRI scans
Transcranial magnetic stimulation TMS is a non-invasive technique that uses a transient electromagnetic field over a small area of the scalp to alter neuronal activity It has been approved by Health Canada for the treatment of major depressive disorder and obsessive-compulsive disorder Despite its clinical prevalence TMS has a response rate of less than 50 and high intra- and inter-subject variability Even among healthy subjects the probability of inducing neuro-modulatory effects can be as low as 50
Design
Depending on the studys aims participants will have to visit Sunnybrook Health Sciences Centre two or three times on separate days Participants will be screened with a medical record review before their first visit
In the first visit participants will have a magnetic resonance imaging MRI session During the MRI session participants will be brought inside an MRI scanner to collect images including structural and functional MRI scans During structural scans participants will be asked to stay inside the MRI while images are taken During functional MRI scans participants will be asked to take rests with eyes open watching andor listening to audiovisual stimuli and respond to stimuli by button pressing Before starting MRI scans a short training on the task will be taken An additional assessment and if necessary training sessions will be conducted to ensure that participants undergo imaging while being able to keep their heads sufficiently for acceptable fMRI data quality Before entering the MRI room participants will be asked to remove any metal or magnetic sensitive objects eg jewelry keys credit cards to ensure safety Earplugs or earphones will be provided to participants to reduce the loud noise produced by the MRI scanner During the MRI scans participants will perform the same task as notified in the training session Short breaks will be arranged between tasks The entire MRI procedure will take approximately one hour If electroencephalograph EEG is to be recorded during MRI scans an additional one hour is needed for EEG preparation before the MRI scans After MRI scans participants may be asked to rate their feelings toward the audiovisual stimuli cognitive states and emotional states on a computer
Participants will be asked to attend TMS-MRI experiments twice on separate days for aim 1 In the TMS-MRI session participants will take TMS and MRI separately For TMS participants will be led to a treatment room and seated in a comfortable chair in a slightly reclined position A research staff will place an electromagnetic coil softly against each participants head A TMS coil will painlessly deliver magnetic pulses stimulating nerve cells at predetermined intervals Electrodes may be mounted on the participants wrists and around the eyes to monitor muscle activities The treatment protocol for each participant will be based on hisher MRI scans EEG signals or motor responses This step may be helped by using a camera During TMS participants will hear clicking sounds generated by the TMS coil and may have touching or twitching senses over their faces After TMS participants will be brought to an MRI room for MRI scans as described above A rating of the participants feelings and task performance may be taken after MRI scans
For aims 2 and 3 participants will be asked to attend a TMS-EEG-MRI experiment once In the TMS-EEG-MRI session participants will first undergo TMS and EEG together Then participants will undergo an MRI For TMS-EEG participants will be led to a treatment room and seated in a comfortable chair in a slightly reclined position Each participant will be asked to wear an EEG cap A device is then used to measure the EEG electrode locations over the cap Then conductive gel will be applied to EEG electrodes over the cap Participants may feel skin scratching when the research staffs apply the conductive gel Additional electrodes will be attached around the participants eyes and wrists to monitor muscle movement During TMS a research staff will place an electromagnetic coil softly against the participants head A TMS coil will painlessly deliver magnetic pulses that stimulate nerve cells The investigators will determine the treatment protocol based on each participants MRI scans EEG signals or motor responses This step may be helped by using a camera During TMS participants will hear clicking sounds generated by the TMS coil and may have touching or twitching senses over their faces After TMS participants will be brought to an MRI room for MRI scans as described above A rating of the participants feelings and task performance may be taken after MRI scans
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None