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

NCT04130958 | Recruiting DMC FDA Device

• 1 other identifier: 2019P002288
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Major Depressive Episode; Borderline Personality Disorder; Suicide

Keywords

Transcranial Magnetic Stimulation; Intermittent Theta Burst

Outcome Measures

Primary Outcomes (1)

• Changes in Functional Connectivity of Key Nodes

  Measured using Magnetic Resonance Imaging

  Through Treatment Completion, Average of 3 Days

Study Arms (4)

MDE and Active iTBS-TMS

EXPERIMENTAL

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

Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)

BPD and Active iTBS-TMS

EXPERIMENTAL

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

Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)

MDE and Sham iTBS-TMS

SHAM COMPARATOR

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

Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)

BPD and Sham iTBS-TMS

SHAM COMPARATOR

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

Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)

Interventions

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.

Also known as: Active iTBS-TMS

BPD and Active iTBS-TMS; MDE and 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.

Also known as: Sham iTBS-TMS

BPD and Sham iTBS-TMS; MDE and Sham iTBS-TMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Borderline Personality Disorder; Suicide

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Joan Camprodon, MD/PhD

  6177265348

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DNN Inbox

CONTACT

6177248780; mghdnn@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: November 1, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)