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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04130958
Other study ID # 2019P002288
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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