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

NCT ID: NCT04130958

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Episode Borderline Personality Disorder Suicide

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MDE and Active iTBS-TMS

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

Group Type EXPERIMENTAL

Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)

Intervention Type DEVICE

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

BPD and Active iTBS-TMS

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

Group Type EXPERIMENTAL

Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)

Intervention Type DEVICE

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

MDE and Sham iTBS-TMS

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

Group Type SHAM_COMPARATOR

Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)

Intervention Type 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.

BPD and Sham iTBS-TMS

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

Group Type SHAM_COMPARATOR

Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Active iTBS-TMS Sham iTBS-TMS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Joan A Camprodon, MD MPH PhD

Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joan Camprodon, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

6177265348

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

DNN Inbox

Role: CONTACT

6177248780

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

DNN Inbox

Role: primary

6177248780

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019P002288

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Home-Based tDCS for Depression in BPD
NCT06972368 RECRUITING NA
PILOT Phase: BPD Study
NCT07223619 ACTIVE_NOT_RECRUITING NA