45 Participants Needed

rTMS for Depression

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Overseen ByNick Bassano, MSW
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using rapid-acting antidepressants like ketamine or have had a recent course of ECT, you may not be eligible to participate.

What data supports the effectiveness of the treatment for depression?

Research shows that intermittent theta burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (DLPFC) is effective in treating major depression, similar to traditional repetitive transcranial magnetic stimulation (rTMS). Additionally, combining iTBS with low-frequency rTMS on the right DLPFC has been found to enhance treatment outcomes when added to standard medication.12345

Is rTMS safe for treating depression?

Research shows that repetitive transcranial magnetic stimulation (rTMS), including intermittent theta burst stimulation (iTBS), is generally safe for treating depression. Studies have found it to be as safe as traditional rTMS methods, with no major safety concerns reported.23456

How is the rTMS treatment for depression unique compared to other treatments?

The rTMS treatment for depression is unique because it uses a specific pattern called intermittent theta burst stimulation (iTBS) targeting the dorsomedial and left dorsolateral prefrontal cortex, which can be as effective as traditional rTMS but is delivered in a shorter time frame, potentially making it more convenient for patients.12457

What is the purpose of this trial?

This study evaluates the antidepressant effects of an accelerated schedule of theta-burst stimulation, termed accelerated intermittent theta-burst stimulation (aiTBS), in individuals with borderline personality disorder (BPD) or trait and comorbid mood depressive disorder (MDD) or bipolar II disorder in a current mood depressive episode (MDE).

Research Team

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Nolan Williams, MD

Principal Investigator

Stanford University

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David Spiegel, MD

Principal Investigator

Stanford University

Eligibility Criteria

Adults aged 22-65 with Borderline Personality Disorder and a current depressive episode, who are in good health, TMS naive, agree to lifestyle guidelines, use effective contraception if applicable, can understand English for assessments/interventions. Excludes pregnant individuals or those with mania/psychosis, substance abuse issues, certain medical conditions like metal implants incompatible with MRI or history of seizures.

Inclusion Criteria

Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and aiTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
I am between 22 and 65 years old.
Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
See 17 more

Exclusion Criteria

My treatment's intensity is more than 65% of the maximum level.
Treatment with another investigational drug or other intervention within the study period
I have a hormone disorder that hasn't been treated enough.
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive accelerated intermittent theta-burst stimulation (aiTBS) over the left dorsolateral prefrontal cortex (L-DLPFC) or dorsomedial prefrontal cortex (DMPFC), or sham stimulation

4 weeks
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of suicidal behaviors and depression severity

4 weeks

Treatment Details

Interventions

  • Dorsomedial Prefrontal Cortex (DMPFC)
  • Left Dorsolateral Prefrontal Cortex (L-DLPFC)
  • Sham Stimulation
Trial Overview The trial tests an accelerated form of theta-burst stimulation (aiTBS) on the brain's left dorsolateral prefrontal cortex and dorsomedial prefrontal cortex versus sham stimulation. It aims to assess aiTBS's effectiveness in alleviating depression symptoms in participants with BPD during a depressive episode.
Participant Groups
3Treatment groups
Active Control
Placebo Group
Group I: Left Dorsolateral Prefrontal Cortex (L-DLPFC)Active Control1 Intervention
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC)
Group II: Dorsomedial Prefrontal Cortex (DMPFC)Active Control1 Intervention
The accelerated theta burst stimulation protocol will be applied to the dorsomedial prefrontal cortex (DMPFC)
Group III: Sham stimulationPlacebo Group1 Intervention
Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC) region

Dorsomedial Prefrontal Cortex (DMPFC) is already approved in United States, Canada for the following indications:

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Approved in United States as rTMS for:
  • Major Depressive Disorder (MDD)
  • Treatment-resistant depression
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Approved in Canada as rTMS for:
  • Major Depressive Disorder (MDD)
  • Treatment-resistant depression

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Findings from Research

In a randomized-controlled trial involving 32 patients with major depression, bilateral theta burst stimulation (TBS) to the dorsolateral prefrontal cortex showed a significant increase in treatment response compared to sham stimulation, with 9 responders in the TBS group versus 4 in the sham group.
The study also indicated a trend towards higher remission rates in the TBS group as measured by the Beck Depression Inventory, suggesting that TBS may enhance the effectiveness of ongoing medication and psychotherapy in treating major depression.
Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial.Plewnia, C., Pasqualetti, P., Große, S., et al.[2018]
Intermittent theta-burst stimulation (iTBS) targeting the left visual cortex (VC) was found to be non-inferior to targeting the left dorsolateral prefrontal cortex (DLPFC) in improving depressive symptoms in patients with major depressive disorder (MDD), based on a study of 75 participants over 14 days.
The VC group experienced lower rates of suicidal ideation and fewer adverse events, such as eye discomfort and pain, suggesting that VC-targeted iTBS may be a safer option for treating MDD.
Non-inferiority of intermittent theta burst stimulation over the left V1 vs. classical target for depression: A randomized, double-blind trial.Kong, Y., Zhou, J., Zhao, M., et al.[2023]
In a study of 71 participants with Major Depressive Disorder who had limited response to high-frequency left-sided stimulation, subthreshold intensity intermittent theta-burst stimulation priming (iTBS-P) led to a greater reduction in depressive symptoms compared to suprathreshold intensity stimulation.
The results suggest that iTBS-P may work through homeostatic plasticity mechanisms, indicating that lower intensity stimulation could be more effective for clinical improvement in depression.
Subthreshold stimulation intensity is associated with greater clinical efficacy of intermittent theta-burst stimulation priming for Major Depressive Disorder.Lee, JC., Corlier, J., Wilson, AC., et al.[2021]

References

Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. [2018]
Non-inferiority of intermittent theta burst stimulation over the left V1 vs. classical target for depression: A randomized, double-blind trial. [2023]
Subthreshold stimulation intensity is associated with greater clinical efficacy of intermittent theta-burst stimulation priming for Major Depressive Disorder. [2021]
The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial. [2023]
Left intermittent theta burst stimulation combined with right low-frequency rTMS as an additional treatment for major depression: A retrospective study. [2022]
Treatment of major depressive disorder with bilateral theta burst stimulation: study protocol for a randomized, double-blind, placebo-controlled multicenter trial (TBS-D). [2022]
Dose-response of intermittent theta burst stimulation of the prefrontal cortex: A TMS-EEG study. [2022]
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