Ignite Creation Date:
2024-05-06 @ 8:22 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02729792
Status:
COMPLETED
Last Update Posted:
2018-07-26
First Post:
2016-03-29
Brief Title:
Canadian rTMS Treatment and Biomarker Network in Depression Trial
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
Canadian rTMS Treatment and Biomarker Network in Depression Trial
Status:
COMPLETED
Status Verified Date:
2018-07
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:
CARTBIND
Brief Summary:
Repetitive transcranial magnetic stimulation rTMS is an emerging treatment for medically refractory major depressive disorder MDD rTMS involves direct stimulation of cortical neurons using externally applied powerful focused magnetic field pulses Dozens of studies and several meta-analyses over the last 15 years have shown that rTMS of the dorsolateral prefrontal cortex DLPFC produces statistically significant improvements in MDD even when medications have failed However other possible targets may also yield improvement in symptoms
In an attempt to enhance the therapeutic efficacy of current interventions for TRD attention has turned to identifying domain-specific biomarkers in hopes of ultimately individualizing and predicting treatment response Unfortunately the precise nature of this relationship is less than clear as reflected by the fact that even now there are no established biomarkers that are used routinely in clinical practice to aid in diagnosis This study also seeks to examine a comprehensive suite of biomarker measurements MRI neurophysiology and genomicsproteomics before and after rTMS treatment
In an attempt to enhance the therapeutic efficacy of current interventions for TRD attention has turned to identifying domain-specific biomarkers in hopes of ultimately individualizing and predicting treatment response Unfortunately the precise nature of this relationship is less than clear as reflected by the fact that even now there are no established biomarkers that are used routinely in clinical practice to aid in diagnosis This study also seeks to examine a comprehensive suite of biomarker measurements MRI neurophysiology and genomicsproteomics before and after rTMS treatment
Detailed Description:
rTMS is a Health-Canada- and FDA-approved treatment for treatment-resistant depression TRD using focused magnetic field pulses to stimulate brain regions involved in emotion regulation safely and non-invasively Though rTMS is often effective where medications or therapy fail it requires a series of lengthy 30-40 min treatment sessions A new form of rTMS called theta burst stimulation TBS has been shown to have greater effects on neural activity than conventional stimulation despite requiring as little as 40 s of stimulation The purpose of this study is to assess the efficacy and tolerability of an accelerated TBS protocol administered 2 times a day in patients with TRD In addition the investigators aim to identify candidate biomarkers from a multimodal suite of neuroimaging neurophysiologic and molecular measures that are predictors and correlates of response to rTMS treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None