Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05813093
Status:
RECRUITING
Last Update Posted:
2023-11-01
First Post:
2023-03-13
Brief Title:
Interleaved TMS-fMRI in Ultra-treatment Resistant Depression
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Interleaved TMS-fMRI to Evaluate Intermittent Theta-burst and Dorsolateral Prefrontal Circuit Engagement in Ultra-treatment Resistant Depression
Status:
RECRUITING
Status Verified Date:
2023-10
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:
This is a study that will recruit patients from the neurosurgery clinic and the regular TMS clinic Its a smaller study designed to collect brain imaging pre-treatment and then use image guided TMS to treat patient with a one week accelerated rTMS protocol using the research TMS machine that is housed in Dr Sean Nestors lab The idea is to examine whether severe treatment resistant depression has a different brain signature than less severeTRD and whether we can get a therapeutic response from patients that would otherwise undergo neurosurgery or will ultimately undergo neurosurgery
Detailed Description:
The objective of this study is to assess plasticity in both whole brain connectivity and a moodaffective circuit involving the dorsolateral prefrontal cortex DLPFC in individuals undergoing repetitive transcranial magnetic stimulation rTMS for treatment of ultra-treatment resistant depression Our second aim is to explore how these markers predict response to rTMS The DLPFC is a brain region known to support mood regulation and has functional brain activity that is altered in depression Past evidence from healthy controls suggests that rTMS increases coupling of the DLPFC network with another functional brain network involved in reward Using sophisticated neuroimaging techniques that concurrently capture functional MRI while patients are being stimulated with rTMS we will identify patterns of brain activity associated with depressed mood and measure the coupling of the DLPFC mood circuit with a reward network prior to an acute course of rTMS Following baseline imaging all patients will then undergo an accelerated rTMS protocol over the course of five days using the pre-treatment imaging to localize the brain region circuit targeted by the TMS coil We will also use questionnaires to assess mood and function before during and after rTMS treatment Two comparison groups will be included in this study 1 patients with depression who have ultra-treatment resistant depression and have been referred for consideration of neurosurgical neuromodulation for depression and 2 persons with milder treatment resistant depression who are referred to the Harquail Centre for rTMS treatment of depression This research will help us better understand the mechanisms of how rTMS modulates brain activity improve TMS targeting in depression and identify pre-treatment imagingEEG markers that predict response to rTMS with potentially far-reaching clinical implications
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?:
False
Is an FDA AA801 Violation?:
None