Rapid-Acting TMS for Depression
Palo Alto (17 mi)Overseen byAlan F. Schatzberg, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Stanford University
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In a double-blind, randomized, sham-controlled fashion, half the participants will receive accelerated theta-burst stimulation while half will receive sham treatment.
Is TBS-DLPFC a promising treatment for depression?Yes, TBS-DLPFC is a promising treatment for depression. It is a newer form of therapy that can be delivered quickly, in just over 3 minutes, compared to traditional methods that take much longer. Studies show it can be effective for people with depression, including those who haven't responded to other treatments. It can be used alongside standard medication and therapy to improve results.245810
What safety data exists for rapid-acting TMS for depression?The safety of theta burst stimulation (TBS), a form of transcranial magnetic stimulation (TMS), has been reviewed in several studies. A systematic review of literature from 2004 to 2009 found that most adverse events were mild, occurring in about 5% of subjects. Although TBS has a theoretical risk of seizures, it is generally considered safe and effective, but should be applied with caution due to its novelty. Another study compared the safety of intermittent theta burst stimulation (iTBS) with high-frequency TMS for treatment-resistant depression, indicating that iTBS is a newer, faster form of TMS. A comparative study on pediatric subjects also highlighted the need for more safety data on TBS. Overall, while TBS is promising, further research is needed to fully understand its safety profile.134910
What data supports the idea that Rapid-Acting TMS for Depression is an effective treatment?The available research shows that Rapid-Acting TMS, specifically intermittent theta burst stimulation (iTBS), is an effective treatment for depression. One study found that iTBS can be delivered in just 3 minutes compared to the 37.5 minutes needed for standard treatments, making it a quicker option. Another study showed that combining iTBS with low-frequency TMS on different parts of the brain can be an effective additional therapy to standard medication. However, while some studies show promising results, like a small percentage of participants achieving remission, others suggest that more research is needed to determine the best way to use this treatment. Compared to traditional high-frequency TMS, iTBS is faster and has shown similar effectiveness, making it a potentially more convenient option for patients.24678
Do I have to stop taking my current medications for the trial?No, you must stay on a stable antidepressant regimen for 6 weeks before and throughout the study.
Eligibility Criteria
This trial is for adults aged 22-65 with Major Depressive Disorder who haven't responded well to other treatments. Participants must be in good health, not have certain mental health conditions or severe personality disorders, and can't be using substances or have metal implants that interfere with MRI scans.Inclusion Criteria
My medical records show I have hard-to-treat depression.
I have been diagnosed with Major Depressive Disorder.
I have been diagnosed with Major Depressive Disorder.
I have never undergone TMS therapy.
I am between 22 and 65 years old.
I have never undergone TMS therapy.
Exclusion Criteria
I have a history of serious brain or nerve conditions.
I do not have metal implants in my head, a history of seizures, or known brain lesions.
My depression symptoms have not worsened by 30% or more recently.
My treatment's intensity is more than 65% of the maximum level.
I've had more than 8 ECT sessions without improvement.
I have a hormone-related condition that is untreated or not fully treated.
Treatment Details
The study tests a rapid version of theta-burst stimulation (TBS) via transcranial magnetic stimulation (TMS) against a sham treatment for depression. It's randomized and double-blind, meaning neither the researchers nor participants know who gets real TBS until after the study.
2Treatment groups
Active Control
Placebo Group
Group I: Active TBS-DLPFCActive Control1 Intervention
The active group will receive theta-burst TMS stimulation.
Group II: Sham TBS-DLPFCPlacebo Group1 Intervention
The sham group will receive sham theta-burst TMS stimulation.
TBS-DLPFC is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as TBS-DLPFC for:
- Treatment-Resistant Depression
🇪🇺 Approved in European Union as TBS-DLPFC for:
- Major Depressive Disorder
- Treatment-Resistant Depression
🇨🇦 Approved in Canada as TBS-DLPFC for:
- Depression
- Anxiety Disorders
Find a clinic near you
Research locations nearbySelect from list below to view details:
Department of Psychiatry and Behavioral Sciences, Stanford School of MedicineStanford, CA
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
References
Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. [2022]Theta burst stimulation (TBS) protocols have recently emerged as a method to transiently alter cortical excitability in the human brain through repetitive transcranial magnetic stimulation. TBS involves applying short trains of stimuli at high frequency repeated at intervals of 200 milliseconds. Because repetitive transcranial magnetic stimulation is known to carry a risk of seizures, safety guidelines have been established. TBS has the theoretical potential of conferring an even higher risk of seizure than other repetitive transcranial magnetic stimulation protocols because it delivers high-frequency bursts. In light of the recent report of a seizure induced by TBS, the safety of this new protocol deserves consideration. We performed an English language literature search and reviewed all studies published from May 2004 to December 2009 in which TBS was applied. The adverse events were documented, and crude risk was calculated. The majority of adverse events attributed to TBS were mild and occurred in 5% of subjects. Based on this review, TBS seems to be a safe and efficacious technique. However, given its novelty, it should be applied with caution. Additionally, this review highlights the need for rigorous documentation of adverse events associated with TBS and intensity dosing studies to assess the seizure risk associated with various stimulation parameters (e.g., frequency, intensity, and location).
Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. [2018]Current efforts to improve clinical effectiveness and utility of repetitive transcranial magnetic stimulation (rTMS) in the treatment of major depression (MD) include theta burst stimulation (TBS), a patterned form of rTMS. Here, we investigated the efficacy of bilateral TBS to the dorsolateral prefrontal cortex (dlPFC) in patients with MD in additon to ongoing medication and psychotherapy.
Safety and tolerability of theta burst stimulation vs. single and paired pulse transcranial magnetic stimulation: a comparative study of 165 pediatric subjects. [2020]Although single- and paired-pulse (sp/pp) transcranial magnetic stimulation (TMS) studies are considered minimal risk in adults and children, the safety profile for theta-burst TMS (TBS) is unknown.
Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. [2022]Treatment-resistant major depressive disorder is common; repetitive transcranial magnetic stimulation (rTMS) by use of high-frequency (10 Hz) left-side dorsolateral prefrontal cortex stimulation is an evidence-based treatment for this disorder. Intermittent theta burst stimulation (iTBS) is a newer form of rTMS that can be delivered in 3 min, versus 37·5 min for a standard 10 Hz treatment session. We aimed to establish the clinical effectiveness, safety, and tolerability of iTBS compared with standard 10 Hz rTMS in adults with treatment-resistant depression.
Accelerated theta burst stimulation for the treatment of depression: A randomised controlled trial. [2022]Theta burst pattern repetitive transcranial magnetic stimulation (TBS) is increasingly applied to treat depression. TBS's brevity is well-suited to application in accelerated schedules. Sizeable trials of accelerated TBS are lacking; and optimal TBS parameters such as stimulation intensity are not established.
A randomized sham controlled comparison of once vs twice-daily intermittent theta burst stimulation in depression: A Canadian rTMS treatment and biomarker network in depression (CARTBIND) study. [2022]Intermittent theta burst stimulation (iTBS) is a newer form of repetitive transcranial magnetic stimulation (rTMS) for patients with treatment resistant depression (TRD). Applying multiple daily iTBS sessions may enable patients to achieve remission more rapidly.
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.
Left intermittent theta burst stimulation combined with right low-frequency rTMS as an additional treatment for major depression: A retrospective study. [2022]Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for major depression (MD). We retrospectively analyzed the efficacy of intermittent theta burst stimulation (iTBS) on the left dorsolateral prefrontal cortex (DLPFC) combined with low-frequency rTMS (LF-rTMS) on the right DLPFC as an additional therapy to standard medication treatment.
The effect of pulse shape in theta-burst stimulation: Monophasic vs biphasic TMS. [2023]Intermittent theta-burst stimulation (i) (TBS) is a transcranial magnetic stimulation (TMS) plasticity protocol. Conventionally, TBS is applied using biphasic pulses due to hardware limitations. However, monophasic pulses are hypothesised to recruit cortical neurons more selectively than biphasic pulses, predicting stronger plasticity effects. Monophasic and biphasic TBS can be generated using a custom-made pulse-width modulation-based TMS device (pTMS).
Efficacy and safety of intermittent theta burst stimulation versus high-frequency repetitive transcranial magnetic stimulation for patients with treatment-resistant depression: a systematic review. [2023]Intermittent theta-burst stimulation (iTBS), which is a form of repetitive transcranial magnetic stimulation (rTMS), can produce 600 pulses to the left dorsolateral prefrontal cortex (DLPFC) in a stimulation time of just over 3 min. The objective of this systematic review was to compare the safety and efficacy of iTBS and high-frequency (≥ 5 Hz) rTMS (HF-rTMS) for patients with treatment-resistant depression (TRD).