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

NCT04130958 · Massachusetts General Hospital
In plain English

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About this study
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.
Eligibility criteria
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
Enrollment target: 80 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2023-11-01
Estimated completion: 2026-04-30
Last updated: 2025-06-12
Interventions
Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)Device: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)
Primary outcomes
  • Changes in Functional Connectivity of Key Nodes (Through Treatment Completion, Average of 3 Days)
Sponsor
Massachusetts General Hospital · other
Contacts & investigators
ContactDNN Inbox · contact · mghdnn@mgh.harvard.edu · 6177248780
InvestigatorJoan Camprodon, MD/PhD · principal_investigator, 6177265348
All locations (1)
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics · TrialPath