Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMassachusetts General Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-65 years of age
Diagnosed with BPD or MDE
Chief complaint of suicidal thoughts and behaviors
Disqualifiers
Neurological conditions with known structural brain lesion
Prior neurosurgical procedure
Metal in the body that is ferromagnetic or metal injury to the eyes
Epilepsy
Trial design
Design model
Parallel
Treatments tested in this trial
Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)
DeviceiTBS-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)
DeviceThe 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.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: MDE and Active iTBS-TMSExperimental treatment 1 intervention
Group B: BPD and Active iTBS-TMSExperimental treatment 1 intervention
Group C: MDE and Sham iTBS-TMSSham comparator 1 intervention
Group D: BPD and Sham iTBS-TMSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in Functional Connectivity of Key Nodes
Measured using Magnetic Resonance Imaging
Time frame
Through Treatment Completion, Average of 3 DaysSponsors and contacts
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Source ClinicalTrials.gov