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

Mass General Brigham

Status: Enrolling

Conditions: Major Depressive Episode; Borderline Personality Disorder; Suicide

Treatments: Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham); Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)

Study type: Interventional

Funder types: Other

Identifiers

NCT04130958

2019P002288

Details and patient eligibility

About

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 episode (MDE) or borderline personality disorder (BPD).

Full description

This neuroimaging study aims to determine the effectiveness of iTBS-TMS to the IPL in reducing suicide risk in patients with MDE or 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-65 years of age
• Diagnosed with BPD or MDE
• Chief complaint of suicidal thoughts and behaviors

Exclusion criteria

• Neurological conditions with known structural brain lesion
• Prior neurosurgical procedure
• Metal in the body that is ferromagnetic or metal injury to the eyes
• Epilepsy
• Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt
• Psychopathology not appropriate for the treatment (e.g., manic episode or psychosis)
• Current alcohol dependence or active symptoms of non-alcohol psychoactive substance use withdrawal, as indicated by self-report
• Inability to meet the safety criteria for MRI scanning according to the protocols of the MGH Department of Radiology
• Current pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups

MDE and Active iTBS-TMS

Experimental group

Description:

This group will consist of patients diagnosed with MDE that are receiving active iTBS-TMS.

Treatment:

Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)

BPD and Active iTBS-TMS

Experimental group

Description:

This group will consist of patients diagnosed with BPD that are receiving active iTBS-TMS.

Treatment:

Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)

MDE and Sham iTBS-TMS

Sham Comparator group

Description:

This group will consist of patients diagnosed with MDE that are receiving sham iTBS-TMS.

Treatment:

Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)

BPD and Sham iTBS-TMS

Sham Comparator group

Description:

This group will consist of patients diagnosed with BPD that are receiving sham iTBS-TMS.

Treatment:

Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)