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

March 20, 2024 updated by: Joan A Camprodon, MD MPH PhD, Massachusetts General Hospital
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02129
        • Recruiting
        • Massachusetts General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: 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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Functional Connectivity of Key Nodes
Time Frame: Through Treatment Completion, Average of 3 Days
Measured using Magnetic Resonance Imaging
Through Treatment Completion, Average of 3 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Joan Camprodon, MD/PhD, 6177265348

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

October 16, 2019

First Posted (Actual)

October 18, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019P002288

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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