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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04130958
Status
Recruiting
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Conditions

  • Borderline Personality Disorder
  • Major Depressive Episode
  • Suicide

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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).

Key Dates

Start date
Nov 1, 2023
Status verified
May 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MDE and Active iTBS-TMS
    This group will consist of patients diagnosed with MDE that are receiving active iTBS-TMS.
  • Experimental: BPD and Active iTBS-TMS
    This group will consist of patients diagnosed with BPD that are receiving 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.
  • Sham Comparator: BPD and Sham iTBS-TMS
    This group will consist of patients diagnosed with BPD that are receiving sham iTBS-TMS.

Primary Outcome Measure

Changes in Functional Connectivity of Key Nodes [ Time Frame: Through Treatment Completion, Average of 3 Days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02129
DNN Inbox
[email protected]
6177248780

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By research site
Massachusetts General Hospital· Boston, MA

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