Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics

Study Overview
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Brief Summary
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This neuroimaging study is a clinical trial investigating the effectiveness of intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) in reducing suicide risk in patients with major depressive disorder (MDD) and borderline personality disorder (BPD).

Detailed Description
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This neuroimaging study aims to determine the effectiveness of iTBS-TMS to the IPL in reducing suicide risk in patients with MDD and BPD. This study also aims to identify the structural and functional circuit properties that characterized the suicidal brain and the signatures that explain the clinical severity of suicidal risk. Moreover, this study aims to determine biological and dimensional predictors of anti-suicidal response to iTBS-TMS and its mechanism of action.

Official Title
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Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics

Conditions
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Major Depressive Disorder, Borderline Personality Disorder, Suicide

Intervention / Treatment
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* Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)
* Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-60 years of age Diagnosed with BPD or MDD Chief complaint of suicidal thoughts and behaviors Ownership of smart phone (e.g., Android, Apple) Permission to use smart phone during an inpatient stay Exclusion Criteria: History of head injury resulting in prolonged loss of consciousness and/or neurological sequelae. Prior neurosurgical procedure. Metal in the body that is ferromagnetic or metal injury to the eyes. History of seizures. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, or ventriculo-peritoneal shunt. Psychopathology not appropriate for the treatment (e.g., manic episode or psychosis). Substance abuse or dependence that is current or within the last six months, as indicated by self-report. Inability to meet the safety criteria for MRI scanning according to the protocols of the Department of Radiology.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MDD and Active iTBS-TMS<br>This group will consist of patients diagnosed with MDD that are receiving active iTBS-TMS. | Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)<br>* iTBS-TMS is a noninvasive neuromodulation technique that uses a powerful magnet to induce focal electrical currents in target brain regions.<br>* Other names: Active iTBS-TMS;|
| Experimental: BPD and Active iTBS-TMS<br>This group will consist of patients diagnosed with BPD that are receiving active iTBS-TMS. | Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)<br>* iTBS-TMS is a noninvasive neuromodulation technique that uses a powerful magnet to induce focal electrical currents in target brain regions.<br>* Other names: Active iTBS-TMS;|
| Sham Comparator: MDD and Sham iTBS-TMS<br>This group will consist of patients diagnosed with MDD that are receiving sham iTBS-TMS. | Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)<br>* The sham version of iTBS-TMS involves placing the magnet over the same target brain region but the device will not be turned on during the treatment. There will be two electrodes placed on the scalp that mimic the sensation of iTBS-TMS but does not induce focal electrical currents.<br>* Other names: Sham iTBS-TMS;|
| Sham Comparator: BPD and Sham iTBS-TMS<br>This group will consist of patients diagnosed with BPD that are receiving sham iTBS-TMS. | Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)<br>* The sham version of iTBS-TMS involves placing the magnet over the same target brain region but the device will not be turned on during the treatment. There will be two electrodes placed on the scalp that mimic the sensation of iTBS-TMS but does not induce focal electrical currents.<br>* Other names: Sham iTBS-TMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Functional Connectivity of Key Nodes | Measured using Magnetic Resonance Imaging | Through Treatment Completion, Average of 3 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Magnetic Stimulation, Intermittent Theta Burst