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

Suicide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04130958
• Other study ID #: 2019P002288
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: DNN Inbox
• Phone: 6177248780
• Email: mghdnn[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 28, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Major Depressive Episode
• Personality Disorders
• Suicide

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Functional Connectivity of Key Nodes	Measured using Magnetic Resonance Imaging	Through Treatment Completion, Average of 3 Days