Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05422417
Status:
RECRUITING
Last Update Posted:
2022-08-17
First Post:
2022-06-07
Brief Title:
Dorsomedial Prefrontal Neuromodulation in Treatment-resistant Depression
Sponsor:
Taipei Veterans General Hospital Taiwan
Organization:
Taipei Veterans General Hospital Taiwan
Study Overview
Official Title:
New Form of Brain Stimulation Targeting Dorsomedial Prefrontal Cortex in Treating Refractory Depression and the Predictive Biomarkers of Antidepressant Efficacy
Status:
RECRUITING
Status Verified Date:
2022-08
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:
Major depressive disorder MDD is a common and troublesome disorder with high risk of physical and psychiatric comorbidity At least one-third of patients could not achieve a response after several antidepressant trials so-called treatment-refractory depression TRD The high-frequency repetitive transcranial magnetic stimulation rTMS or intermittent theta-burst stimulation iTBS at left-sided dorsolateral prefrontal cortex DLPFC have a response rate of 40-60 Obviously not all TRD patients achieve the remitted state after treatment with antidepressants or DLPFC-rTMS which may result from the heterogeneity of MDD More and more evidence such as brain lesion studies deep brain stimulation open-labeled rTMS case series and neuroimaging studies suggests that dorsomedial prefrontal cortex DMPFC might play a more central role in the pathophysiology of major depression The DMPFC demonstrated as a dorsal nexus phenomenon in depression which means a unique brain region where cortical networks for affect regulation default mode control and cognitive control coverage in depressed subjects but not in healthy persons In addition another meta-analysis of resting-state functional MRI fMRI demonstrated the abnormal functional connectivity from DMPFC These abnormalities of networks were highly associated with several depressive symptoms such as anhedonia emotional regulation somatic markers rumination self-reflection poor attention and poor decision-making However only a handful of studies investigated the brain stimulation targeting DMPFC and the further changes in brain functional connectivity The clinical efficacy and the fMRI changes of prolonged intermittent theta-burst stimulation piTBS and 20Hz- rTMS targeting bilateral DMPFC were investigated and the predictive value of baseline networks by fMRI for antidepressant responses was also assessed to find a reliable approach to gauge treatment response prospectively
Detailed Description:
Several open label studies showed the preliminary clinical efficacy of DMPFC stimulation but there was no randomized sham-control trial to confirm the clinical efficacy in Asian people In addition there were also few fMRI studies to express the brain circuit changes after DMPFC stimulation The clinical efficacy and the fMRI changes of prolonged intermittent theta-burst stimulation piTBS and 20Hz- rTMS targeting bilateral DMPFC were investigated and the predictive value of baseline networks by fMRI for antidepressant responses was also assessed to find a reliable approach to gauge treatment response prospectively All patients with TRD who failed at least one antidepressant trial are randomized to three groups Group-A piTBS treatment Group-B 20Hz-rTMS treatment Group-C sham treatment Before and after 20 sessions targeting bilateral DMPFC over ten days structural and functional magnetic resonance imaging MRI is arranged for each participant In addition pre- and post-treatment fMRI data are analyzed for each patient to investigate the networks and local brain activity changes between groups
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