Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics
NCT ID: NCT04130958
Last Updated: 2025-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-11-01
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MDE and Active iTBS-TMS
This group will consist of patients diagnosed with MDE that are receiving active iTBS-TMS.
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.
BPD and Active iTBS-TMS
This group will consist of patients diagnosed with BPD that are receiving active iTBS-TMS.
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.
MDE and Sham iTBS-TMS
This group will consist of patients diagnosed with MDE that are receiving sham iTBS-TMS.
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.
BPD and Sham iTBS-TMS
This group will consist of patients diagnosed with BPD that are receiving sham iTBS-TMS.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with BPD or MDE
* Chief complaint of suicidal thoughts and behaviors
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Joan A Camprodon, MD MPH PhD
Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation
Principal Investigators
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Joan Camprodon, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
6177265348
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019P002288
Identifier Type: -
Identifier Source: org_study_id
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