RecruitingNot ApplicableNCT05377177

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

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

Enrollment

76 participants

Start Date

Sep 2, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of brain stimulation treatment — one targeting both sides of the brain versus just one side — for people with treatment-resistant depression who are also having thoughts of suicide. It uses a technique called theta burst stimulation (TBS), a form of non-invasive magnetic brain stimulation. **You may be eligible if...** - You are between 18 and 70 years old - You have a diagnosis of major depression that has not responded to at least two antidepressant medications - You are currently having thoughts of suicide - You are medically cleared to receive brain stimulation (TMS) treatment **You may NOT be eligible if...** - You have a metal implant in your head or other MRI/TMS contraindications - You have a history of seizures or another major neurological condition - Your depression is part of bipolar disorder or a psychotic condition - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAccelerated Theta Burst Stimulation

B65 magnetic coil stimulation applied to the dorsal lateral prefrontal cortex.


Locations(1)

UCSD Interventional Psychiatry

San Diego, California, United States

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NCT05377177


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