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: 3

Duration: 1 week

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) can reduce the risk of suicide in individuals with major depressive episodes (MDE) or borderline personality disorder (BPD). The study includes two groups: one receives the actual treatment, while the other receives a sham version for comparison. Suitable participants are those diagnosed with either MDE or BPD and experiencing suicidal thoughts or behaviors. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.

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 prior data suggests that intermittent theta-burst transcranial magnetic stimulation is safe for reducing suicide risk?

Research has shown that intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) is generally safe. One study found it safe for patients with major depressive disorder, even with increased frequency. Another study demonstrated its safety in treating depression and self-harm behaviors in teenagers. Additionally, research on iTBS for borderline personality disorder also confirmed its safety. Overall, these studies suggest that people usually tolerate iTBS-TMS well, with no major side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Intermittent Theta Burst Transcranial Magnetic Stimulation (iTBS-TMS) for its potential in treating suicidal thoughts associated with Major Depressive Episodes (MDE) and Borderline Personality Disorder (BPD). Unlike traditional treatments like antidepressants and psychotherapy, which can take weeks to show effects, iTBS-TMS offers a non-invasive approach that could deliver faster results by directly stimulating brain regions linked to mood regulation. This technique uses magnetic fields to target specific areas of the brain, potentially leading to quicker improvements in symptoms. Additionally, because it doesn't involve medication, it may have fewer side effects, making it a promising option for those who haven't responded well to traditional therapies.

What evidence suggests that this trial's treatments could be effective in reducing suicide risk in patients with MDE or BPD?

Research has shown that intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) holds promise for treating major depressive episodes (MDE). In this trial, some participants will receive active iTBS-TMS, which studies have found to be safe and effective, with results similar to those in regular medical settings. For borderline personality disorder (BPD), iTBS-TMS has been tested alongside therapies like dialectical behavior therapy (DBT). Early results from small studies suggest it might help reduce impulsive behavior in BPD patients, but more research is needed. This trial will also include a sham iTBS-TMS group to compare outcomes. Overall, iTBS-TMS could be a useful treatment for both MDE and BPD, but further studies are ongoing. ^{5 6 7 8 9}

Who Is on the Research Team?

Joan Camprodon, MD/PhD

Principal Investigator

6177265348

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) to reduce suicide risk

1 week

Daily visits for 3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39297977/

Effects of intermittent theta burst stimulation add-on to ... We performed a single-blind, randomized, sham-controlled pilot study to evaluate iTBS as an add-on to 8-week DBT for BPD in routine inpatient treatment.

2. link.springer.com link.springer.com/article/10.1007/s00406-024-01901-0

Effects of intermittent theta burst stimulation add-on to ... We performed a single-blind, randomized, sham-controlled pilot study to evaluate iTBS as an add-on to 8-week DBT for BPD in routine inpatient treatment.

3. bpded.biomedcentral.com bpded.biomedcentral.com/articles/10.1186/s40479-025-00278-3

Effects on impulsivity and delay discounting of intermittent ... iTBS may offer long-term benefits as an add-on treatment to DBT for impulsivity in BPD, suggesting the need for further investigation in larger-scale studies.

4. sciencedirect.com sciencedirect.com/science/article/pii/S305052912500100X

Transcranial magnetic stimulation to treat 101 patients with ... In this open-label, naturalistic study, we evaluated the feasibility, tolerability, and effectiveness of intermittent theta burst stimulation (iTBS) in a sample ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10787000/

Theta burst stimulation add on to dialectical behavioral ... This study protocol describes the methods and design of a randomized, single-blinded, sham-controlled clinical pilot study

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5037167/

Accelerated Intermittent Theta Burst Stimulation for Suicide ... Conclusions: This accelerated iTBS protocol was safe. The observed significant decrease in suicide risk was unrelated to active or sham stimulation and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03601117

Accelerated Intermittent Theta Burst Stimulation for ... This study evaluates an accelerated schedule of theta-burst stimulation for depressive symptoms in psychiatric inpatients.

8. nature.com nature.com/articles/s41380-025-03183-x

Intermittent theta burst stimulation for non-suicidal self ... Intermittent theta burst stimulation (iTBS) shows promise for treating NSSI in adolescents with depression. The efficacy of iTBS for treating ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0165032723000770/pdf

Effect of intermittent theta burst stimulation on suicidal ... Suicidal ideation is a serious symptom of major depressive disorder (MDD). Intermittent theta burst stimulation (iTBS) is a safe, ...