This study aims to explore how repetitive transcranial magnetic stimulation (rTMS), a treatment for depression, affects brain function. Depression disrupts the brain's complex network or regions that regulate cognition, emotion, and behavior. rTMS targets these disruptions to restore network function. To measure these effects, researchers will use dry quantitative EEG (qEEG), a new technology that records brain electrical activity quickly (15 minutes compared to 1 hour for traditional EEG) without the need for gel or lengthy electrode setups. This study will evaluate a novel qEEG activity developed by iMediSync (Republic of South Korea) in patients treated with neuromodulation for depression before, during, and up to 12 months after treatment to see if changes in brain activity to identify patterns associated with symptomatic improvement and relapse risk. Findings could help personalize depression treatments by predicting patient outcomes and optimizing care.
The objective of this study is to evaluate functional brain activity measures that correlate with clinically assessed mood symptoms and their changes before, during, and after repetitive transcranial magnetic stimulation (rTMS) treatment for a major depressive episode. A secondary aim is to explore the relationship between pre- and post-treatment functional brain changes and depression outcomes, including changes in depression scores, response rates, and remission status. The dorsolateral prefrontal cortex (DLPFC), a brain region involved in mood regulation, shows altered activity in depression and will be targeted in this study. All patients in this study will undergo an accelerated rTMS protocol over the course of five days, using the pre-treatment imaging to localize the brain region (i.e. DLPFC) targeted by the TMS coil. In addition to rTMS, the investigators will administer questionnaires to evaluate mood and function at multiple time points: before, during, and after treatment. Patients will also undergo dry quantitative EEG (qEEG), which records brain electrical activity to see how these networks are altered in depression and rescued by rTMS. Participants will also undergo dry quantitative EEG (qEEG) recordings, a method that measures brain electrical activity, to investigate how brain networks are disrupted in depression and how they are modulated by rTMS. Participants who respond to rTMS will be monitored for recurrence of depressive symptoms during follow-up visits. If depressive symptoms worsen, maintenance treatment will be administered. Two maintenance TMS protocols will be compared in this study: 1) a gradually tapering protocol involving once-daily treatments delivered weekly for one month, followed by a gradual taper to one treatment every two weeks for two months, 2) a cluster protocol involving five treatments delivered over two consecutive weekdays (e.g., two treatments on Day 1 and three treatments on Day 2, or vice versa). This research aims to deepen our understanding of the mechanisms by which rTMS modulates brain activity, improve our ability to predict treatment response, and determine the most effective maintenance treatment protocol for sustained symptom relief.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
rTMS is a non-invasive brain stimulation that uses magnetic fields to stimulate specific areas of the brain. It is commonly used for the treatment of neurological and psychiatric disorders, such as major depressive disorder (MDD), anxiety, and sometimes ALS.
Sunnybrook Health Sciences Centre
North York, Ontario, Canada
NOT_YET_RECRUITINGSunnybrook Health Sciences Centre
Toronto, Ontario, Canada
RECRUITINGChange in Depression Score on the Montgomery-Asberg Depression Rating Scale (MADRS)
Change in depression symptomatology as assessed by the clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) (range 0-60). Higher scores indicate worse outcomes
Time frame: 2 years
Changes in functional connectivity
Change between baseline measured qEEG resting-state connectivity and post TMS qEEG connectivity
Time frame: 2 years
Relapse rates measured on the Montgomery-Asberg Depression Rating Scale
Examine relapse rates on the depression rating scale (0-60) over 12 months, following successful response to neuromodulation with qEEG
Time frame: 2 years
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