Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID04130958

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

Led by Massachusetts General Hospital · Updated on 2025-06-12

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the use of intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) targeting the inferior parietal lobule (IPL) to reduce suicide risk in adults diagnosed with major depressive episode (MDE) or borderline personality disorder (BPD). This neuroimaging clinical trial also aims to identify brain circuit features linked to suicidal behavior and to understand biological predictors and mechanisms of response to this treatment. Participants are randomly assigned to one of four groups: those with MDE or BPD receiving active iTBS-TMS, and those with MDE or BPD receiving a sham (inactive) version of iTBS-TMS. The active treatment uses a magnetic device to stimulate specific brain areas, while the sham procedure mimics the sensation without actual brain stimulation. Treatments are delivered using a specialized device over the target brain region. During the study, participants undergo neuroimaging scans and assessments to monitor changes in brain connectivity related to treatment response. The primary outcome measured is the change in functional connectivity of key brain nodes, assessed throughout the treatment period averaging three days. Researchers also evaluate clinical severity of suicidal risk and monitor participants for safety, with the entire involvement lasting through treatment completion and follow-up as planned.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 to 65 years of age
  • Diagnosed with borderline personality disorder or major depressive episode
  • Chief complaint of suicidal thoughts and behaviors
Not Eligible

You will not qualify if you...

  • Neurological conditions with known structural brain lesion
  • Prior neurosurgical procedure
  • Presence of ferromagnetic metal in the body 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 treatment (e.g., manic episode or psychosis)
  • Current alcohol dependence or active symptoms of non-alcohol psychoactive substance withdrawal
  • Inability to meet safety criteria for MRI scanning
  • Current pregnancy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Approximately 3 days

Participants receive intermittent theta burst transcranial magnetic stimulation (iTBS-TMS) or sham treatment targeting specific brain regions.

3 treatment visits (in-person)

Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02129

Actively Recruiting

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Research Team

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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