rTMS for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new brain stimulation technique called accelerated intermittent theta-burst stimulation (aiTBS) to evaluate its effectiveness for people with depression, particularly those with borderline personality disorder or bipolar II disorder. The treatment targets specific brain areas linked to mood regulation. Participants will receive either active brain stimulation or a sham (inactive) version for comparison. Suitable candidates for this trial include individuals diagnosed with major depressive disorder or bipolar II, currently experiencing a depressive episode, and who have not previously undergone transcranial magnetic stimulation (TMS). As an unphased study, this trial offers the chance to contribute to groundbreaking research that could enhance future depression treatments.
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 prior data suggests that this protocol is safe for treating depression?
Research has shown that treatments targeting the Dorsomedial Prefrontal Cortex (DMPFC) and the Left Dorsolateral Prefrontal Cortex (L-DLPFC) are generally safe and well-tolerated. Specifically, for the DMPFC, both 10 Hz and intermittent theta burst stimulation (iTBS) are safe at specific intensity levels. For the L-DLPFC, theta burst stimulation (TBS) is considered safe and acceptable, even for individuals with long-term health conditions.
These treatments have been tested in various studies and are used for multiple conditions, demonstrating a strong safety record. However, individual experiences may vary, so discussing any concerns with a healthcare provider is important.12345Why are researchers excited about this trial?
Researchers are excited about the rTMS protocol for depression because it offers a potentially faster-acting alternative to traditional antidepressants and therapy. Unlike standard treatments, which often require weeks to take effect, rTMS uses accelerated theta burst stimulation aimed at specific brain areas, such as the dorsomedial and left dorsolateral prefrontal cortex, to quickly modulate brain activity. This non-invasive approach could provide quicker relief from depressive symptoms, which is a significant advantage for those seeking faster improvement in their mental health.
What evidence suggests that this trial's treatments could be effective for depression?
Research shows that stimulating certain brain areas might help manage depression and anxiety. In this trial, participants will receive different types of stimulation. Specifically, studies have found that high-dose intermittent theta-burst stimulation (iTBS) on the dorsomedial prefrontal cortex (DMPFC) is safe and may help treat depression that hasn't responded to other treatments, with benefits increasing over time. For the left dorsolateral prefrontal cortex (L-DLPFC), evidence suggests that theta-burst stimulation (TBS) can significantly improve depression symptoms. These findings offer hope for using these brain areas in treating depression, especially when traditional methods haven't worked.23567
Who Is on the Research Team?
Nolan Williams, MD
Principal Investigator
Stanford University
David Spiegel, MD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of suicidal behaviors and depression severity
What Are the Treatments Tested in This Trial?
Interventions
- Dorsomedial Prefrontal Cortex (DMPFC)
- Left Dorsolateral Prefrontal Cortex (L-DLPFC)
- Sham Stimulation
Dorsomedial Prefrontal Cortex (DMPFC) is already approved in United States, Canada for the following indications:
- Major Depressive Disorder (MDD)
- Treatment-resistant depression
- Major Depressive Disorder (MDD)
- Treatment-resistant depression
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor