Borderline Personality Disorder, Major Depressive Episode, Suicide
Conditions
Keywords
Transcranial Magnetic Stimulation, Intermittent Theta Burst
Brief 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).
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.
Interventions
DEVICEIntermittent 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.
DEVICEIntermittent 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Functional Connectivity of Key Nodes | Through Treatment Completion, Average of 3 Days | Measured using Magnetic Resonance Imaging |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoan Camprodon, MD/PhD
6177265348
Outcome results
None listed