Anxiety & Depression Association of America

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

Purpose

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).

Conditions

Major Depressive Episode
Borderline Personality Disorder
Suicide

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Single (Participant)

Arm Groups

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

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Massachusetts General Hospital

Study Contact

DNN Inbox
6177248780
mghdnn@mgh.harvard.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.