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

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).

Completed

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Key information

Conditions

Major Depressive Episode Behavior Behavioral Symptoms Borderline Personality Disorder Mental Disorders Personality Disorders Self-Injurious Behavior Suicide

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)

Device

iTBS-TMS is a noninvasive neuromodulation technique that uses a powerful magnet to induce focal electrical currents in target brain regions.

Other names: Active iTBS-TMS

Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)

Device

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.

Other names: Sham iTBS-TMS

Primary outcomes

Changes in Functional Connectivity of Key Nodes

Time frame: Through Treatment Completion, Average of 3 Days

Measured using Magnetic Resonance Imaging

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Oct 18, 2019
Registry last updated: Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed