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

Not Applicable

Recruiting

• Conditions: Borderline Personality Disorder; Suicide; Major Depressive Episode
• Interventions: Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active); Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)

• Registration Number: NCT04130958
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Study Start: 2023-11-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22
• Primary Completion: 2025-01-31
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BPD and Active iTBS-TMS	Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)	This group will consist of patients diagnosed with BPD that are receiving active iTBS-TMS.
MDE and Sham iTBS-TMS	Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)	This group will consist of patients diagnosed with MDE that are receiving sham iTBS-TMS.
BPD and Sham iTBS-TMS	Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)	This group will consist of patients diagnosed with BPD that are receiving sham iTBS-TMS.
MDE and Active iTBS-TMS	Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)	This group will consist of patients diagnosed with MDE that are receiving active iTBS-TMS.

Primary Outcome Measures

Name	Time	Method
Changes in Functional Connectivity of Key Nodes	Through Treatment Completion, Average of 3 Days	Measured using Magnetic Resonance Imaging

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States