TMS for Suicide
Palo Alto (17 mi)Overseen byJoan Camprodon, MD/PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Massachusetts General Hospital
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of 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).
Is the treatment Intermittent Theta Burst Stimulation (iTBS) a promising treatment for reducing suicide risk?Yes, Intermittent Theta Burst Stimulation (iTBS) is a promising treatment for reducing suicide risk. Studies show that it can safely and effectively lower suicidal thoughts in people with depression, including those who have not responded to other treatments.12356
What safety data exists for TMS in treating suicide risk?The safety of intermittent theta burst stimulation (iTBS) for treating suicide risk has been evaluated in several studies. An accelerated iTBS protocol was found to be safe and well-tolerated in therapy-resistant depressed patients, with no worsening of suicidal ideation observed. Another study confirmed iTBS as a safe treatment for reducing suicidal ideation in adults with major depressive disorder. Additionally, a case series on prolonged iTBS reported some tolerability issues, but overall, iTBS is considered a safe brain stimulation treatment for addressing suicide risk.12456
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude participants with certain conditions and devices, so it's best to discuss your specific medications with the trial coordinators.
What data supports the idea that TMS for Suicide is an effective treatment?The available research shows that TMS for Suicide, specifically using intermittent theta burst stimulation (iTBS), can effectively reduce suicidal thoughts in people with depression. One study found a significant decrease in suicide risk that lasted up to a month, even in those who did not respond to depression treatment. Another study confirmed that iTBS is a safe and effective way to reduce suicidal thoughts in both adults and adolescents with major depressive disorder. These findings suggest that iTBS can be a promising treatment for reducing suicide risk in people with depression.12356
Eligibility Criteria
This trial is for adults aged 18-60 with major depressive disorder (MDD) or borderline personality disorder (BPD), who are experiencing suicidal thoughts and behaviors. Participants must own a smartphone and be able to use it during their inpatient stay. Those with metal implants, history of seizures, recent substance abuse, or certain psychopathologies like psychosis are not eligible.Treatment Details
The study tests intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) on the inferior parietal lobule to see if it lowers suicide risk in patients with MDD or BPD. It compares active iTBS-TMS treatment against a sham (placebo-like) procedure.
4Treatment groups
Experimental Treatment
Placebo Group
Group I: MDE and Active iTBS-TMSExperimental Treatment1 Intervention
This group will consist of patients diagnosed with MDE that are receiving active iTBS-TMS.
Group II: BPD and Active iTBS-TMSExperimental Treatment1 Intervention
This group will consist of patients diagnosed with BPD that are receiving active iTBS-TMS.
Group III: MDE and Sham iTBS-TMSPlacebo Group1 Intervention
This group will consist of patients diagnosed with MDE that are receiving sham iTBS-TMS.
Group IV: BPD and Sham iTBS-TMSPlacebo Group1 Intervention
This group will consist of patients diagnosed with BPD that are receiving sham iTBS-TMS.
Intermittent Theta Burst Transcranial Magnetic Stimulation (Active) is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as iTBS for:
- Major Depressive Disorder (MDD)
- Treatment-resistant depression
🇪🇺 Approved in European Union as iTBS for:
- Major Depressive Disorder (MDD)
- Treatment-resistant depression
Find a clinic near you
Research locations nearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
References
The acute effects of accelerated repetitive Transcranial Magnetic Stimulation on suicide risk in unipolar depression: preliminary results. [2022]Suicide is a major health concern. Effective acute interventions are lacking. Recent studies have suggested an acute decrease of suicidal ideations following repetitive Transcranial Magnetic Stimulation (rTMS). However, placebo effects could not be excluded. We aimed to evaluate the acute effect of accelerated intermittent theta burst stimulation (TBS) on suicide risk in depression.
Accelerated Intermittent Theta Burst Stimulation for Suicide Risk in Therapy-Resistant Depressed Patients: A Randomized, Sham-Controlled Trial. [2020]Objectives: We aimed to examine the effects and safety of accelerated intermittent Theta Burst Stimulation (iTBS) on suicide risk in a group of treatment-resistant unipolar depressed patients, using an extensive suicide assessment scale. Methods: In 50 therapy-resistant, antidepressant-free depressed patients, an intensive protocol of accelerated iTBS was applied over the left dorsolateral prefrontal cortex (DLPFC) in a randomized, sham-controlled crossover design. Patients received 20 iTBS sessions over 4 days. Suicide risk was assessed using the Beck Scale of Suicide ideation (BSI). Results: The iTBS protocol was safe and well tolerated. We observed a significant decrease of the BSI score over time, unrelated to active or sham stimulation and unrelated to depression-response. No worsening of suicidal ideation was observed. The effects of accelerated iTBS on mood and depression severity are reported in Duprat et al. (2016). The decrease in suicide risk lasted up to 1 month after baseline, even in depression non-responders. Conclusions: This accelerated iTBS protocol was safe. The observed significant decrease in suicide risk was unrelated to active or sham stimulation and unrelated to depression response. Further sham-controlled research in suicidal depressed patients is necessary. (Clinicaltrials.gov identifier: NCT01832805).
Effect of high frequency versus theta-burst repetitive transcranial magnetic stimulation on suicidality in patients with treatment-resistant depression. [2023]To investigate the effect of 10 Hz repetitive transcranial magnetic stimulation (rTMS) and intermittent theta-burst stimulation (iTBS) on suicidality in patients with treatment-resistant depression (TRD).
Prolonged intermittent theta burst stimulation in the treatment of major depressive disorder: a case series. [2022]Intermittent theta burst stimulation (iTBS) using 600 pulses is an effective and FDA-cleared transcranial magnetic stimulation (TMS) protocol for major depressive disorder (MDD). Prolonged iTBS (piTBS) using 1,800 pulses could increase the effectiveness of TMS for MDD, but its real-world effectiveness is still debated. We assessed the safety, tolerability, and preliminary effectiveness of a 3x daily piTBS 1,800 pulses protocol delivered over 2 weeks in 27 participants. Only four participants (18.2%) achieved response, two of them achieving remission (9.1%). Five participants (18.5%) experienced tolerability issues. Future studies should focus on the neurophysiological effects of TBS protocols to determine optimal parameters.
Suicidality and relief of depressive symptoms with intermittent theta burst stimulation in a sham-controlled randomized clinical trial. [2023]Suicidality is a serious public health problem and is closely associated with the severity of depression. In this work, we examined the effects of accelerated intermittent theta burst stimulation (iTBS) on suicidal status, risk factors for suicide, and severity of depressive symptoms in subjects with major depressive disorder (MDD).
Effect of intermittent theta burst stimulation on suicidal ideation and depressive symptoms in adolescent depression with suicide attempt: A randomized sham-controlled study. [2023]Suicidal ideation is a serious symptom of major depressive disorder (MDD). Intermittent theta burst stimulation (iTBS) is a safe, effective brain stimulation treatment for alleviating suicidal ideation in adults with MDD. This study aimed to examine the clinical efficacy of iTBS on reducing suicidal ideation in adolescent MDD with suicide attempt.