Ignite Creation Date:
2024-05-06 @ 5:38 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05377177
Status:
RECRUITING
Last Update Posted:
2024-02-12
First Post:
2022-03-24
Brief Title:
Cortical Inhibition As a Biomarker of Response in a Comparison of Bilateral Versus Unilateral Accelerated Theta Burst Stimulation for Suicidal Ideation in Treatment-Resistant Depression -COMBAT-SI
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Bilateral Accelerated Theta Burst Stimulation aTBS for Suicidal Ideation in Treatment-Resistant Depression
Status:
RECRUITING
Status Verified Date:
2024-02
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:
COMBAT-SI
Brief Summary:
This is a prospective clinical trial to confirm the effectiveness of bilateral accelerated theta burst stimulation aTBS on suicidal ideation SI while exploring cortical inhibition measures in this treatment paradigm In this proposed study the investigators will evaluate the anti-suicidal effects of bilateral aTBS over the DLPFC compared to accelerated intermittent theta burst stimulation aiTBS over the left DLPFC in participants with TRD and SI Additionally the investigators aim to identify neurophysiological targets through which bilateral aTBS induces remission of SI in TRD differentially from aiTBS
Detailed Description:
Suicidality is a growing epidemic as over 700000 people die by suicide around the world annually Current treatments for suicidality are limited and novel treatments for suicidality are desperately needed There is early evidence to suggest that the non-invasive brain stimulation treatment called repetitive transcranial magnetic stimulation or rTMS is better than placebo at eliminating suicidal ideation SI in patients with hard to treat depressive illness treatment-resistant depression TRD The UCSD Interventional Psychiatry lab was the first group to demonstrate that bilateral rTMS targeted to specific areas of the frontal lobes of the brain is more effective than placebo for SI Recent evidence from the lab also showed that improvement in SI with brain stimulation treatment is correlated with changes in specific measures of neuronal communication that is cortical inhibition in these same brain regions A prospective clinical trial to confirm the effectiveness of bilateral rTMS on SI while exploring cortical inhibition measures in this treatment paradigm is prudent and urgently needed In this proposed study the investigators plan to evaluate the anti-suicidal effects of bilateral aTBS over the DLPFC an accelerated form of rTMS delivered with multiple theta burst treatments per day compared to aiTBS over the left DLPFC in participants with TRD and SI Additionally the investigators aim to identify neurophysiological targets through which bilateral aTBS induces remission of SI in TRD differentially from aiTBS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None