TMS for Suicide

Overseen By DNN Inbox

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Epilepsy, Alcohol dependence, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

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).

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. ^{1 2 3 4 5}

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. ^{2 3 4 5 6}

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. ^{1 2 3 4 5}

Research Team

Joan Camprodon, MD/PhD

Principal Investigator

6177265348

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.

Inclusion Criteria

My doctor has just given me permission to use my smart phone during my inpatient stay

You own a smartphone, such as an Android or an Apple device.

You have expressed thoughts of hurting or killing yourself.

Exclusion Criteria

Prior neurosurgical procedure.

You have metal in your body that can be affected by magnets or have had an injury to your eyes from metal.

Inability to meet the safety criteria for MRI scanning according to the protocols of the Department of Radiology.

Treatment Details

Interventions

• Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)
• Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)

Trial Overview 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.

Participant Groups

Group I: MDE and Active iTBS-TMS Experimental Treatment 1 Intervention

This group will consist of patients diagnosed with MDE that are receiving active iTBS-TMS.

Group II: BPD and Active iTBS-TMS Experimental Treatment 1 Intervention

This group will consist of patients diagnosed with BPD that are receiving active iTBS-TMS.

Group III: MDE and Sham iTBS-TMS Placebo Group 1 Intervention

This group will consist of patients diagnosed with MDE that are receiving sham iTBS-TMS.

Group IV: BPD and Sham iTBS-TMS Placebo Group 1 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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

In a clinical trial involving patients with treatment-resistant depression, both 10 Hz repetitive transcranial magnetic stimulation (rTMS) and intermittent theta-burst stimulation (iTBS) effectively reduced suicidality, with remission rates of 43.7% and 49.1% respectively, showing no significant difference between the two methods.

There was a strong correlation between reductions in suicidality and overall depression severity, indicating that improvements in suicidal thoughts were linked to greater decreases in depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of high frequency versus theta-burst repetitive transcranial magnetic stimulation on suicidality in patients with treatment-resistant depression. Mehta, S., Downar, J., Mulsant, BH., et al.[2023]

Accelerated intermittent theta burst stimulation (TBS) was found to be safe and well tolerated in 12 suicidal therapy-resistant depressed patients, showing a significant decrease in suicidal ideation over time.

However, the reduction in suicidal thoughts was not definitively linked to the active TBS treatment compared to sham stimulation, indicating that further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The acute effects of accelerated repetitive Transcranial Magnetic Stimulation on suicide risk in unipolar depression: preliminary results. Desmyter, S., Duprat, R., Baeken, C., et al.[2022]

Intermittent theta burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex significantly reduced suicidal ideation and depressive symptoms in adolescents with major depressive disorder over a 2-week treatment period involving 10 sessions.

The study involved 45 participants, and those with higher initial depression and suicidal ideation scores experienced greater improvements, suggesting that iTBS is particularly effective for more severely affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intermittent theta burst stimulation on suicidal ideation and depressive symptoms in adolescent depression with suicide attempt: A randomized sham-controlled study. Zhao, Y., He, Z., Luo, W., et al.[2023]

Accelerated intermittent Theta Burst Stimulation (iTBS) was found to be safe and well tolerated in a study of 50 treatment-resistant depressed patients, with no worsening of suicidal ideation observed during the treatment.

The study showed a significant decrease in suicide risk, as measured by the Beck Scale of Suicide Ideation, lasting up to one month after treatment, regardless of whether patients received active or sham stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Intermittent Theta Burst Stimulation for Suicide Risk in Therapy-Resistant Depressed Patients: A Randomized, Sham-Controlled Trial. Desmyter, S., Duprat, R., Baeken, C., et al.[2020]

In a study involving 81 participants with major depressive disorder, accelerated intermittent theta burst stimulation (iTBS) significantly reduced suicidality and depressive symptoms over a 6-week period, indicating its potential as an effective treatment.

The intervention was found to be safe, with no serious adverse events reported, and showed particularly pronounced anti-suicidal effects in individuals with higher risk profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicidality and relief of depressive symptoms with intermittent theta burst stimulation in a sham-controlled randomized clinical trial. Wilkening, J., Witteler, F., Goya-Maldonado, R.[2023]

In a study of 27 participants, a prolonged intermittent theta burst stimulation (piTBS) protocol using 1,800 pulses showed limited effectiveness for major depressive disorder, with only 18.2% of participants achieving a response and 9.1% reaching remission.

Safety and tolerability were concerns, as 18.5% of participants experienced issues, suggesting that while piTBS is a promising approach, further research is needed to optimize its parameters and improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged intermittent theta burst stimulation in the treatment of major depressive disorder: a case series. Richard, M., Noiseux, C., Desbeaumes Jodoin, V., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of high frequency versus theta-burst repetitive transcranial magnetic stimulation on suicidality in patients with treatment-resistant depression. [2023]

2. Croatia pubmed.ncbi.nlm.nih.gov

The acute effects of accelerated repetitive Transcranial Magnetic Stimulation on suicide risk in unipolar depression: preliminary results. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of intermittent theta burst stimulation on suicidal ideation and depressive symptoms in adolescent depression with suicide attempt: A randomized sham-controlled study. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Accelerated Intermittent Theta Burst Stimulation for Suicide Risk in Therapy-Resistant Depressed Patients: A Randomized, Sham-Controlled Trial. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Suicidality and relief of depressive symptoms with intermittent theta burst stimulation in a sham-controlled randomized clinical trial. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

Prolonged intermittent theta burst stimulation in the treatment of major depressive disorder: a case series. [2022]