Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Brigham and Women's Hospital
No Placebo Group
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This trial tests aiTBS, a magnetic brain stimulation method, on patients with depression that hasn't responded to other treatments. The treatment uses magnetic pulses to reset brain activity and improve mood. Participants will receive aiTBS either guided by brain scans or by physical measurements of the head. Intermittent Theta Burst Stimulation (iTBS) is a newer form of repetitive Transcranial Magnetic Stimulation (rTMS) that has shown potential for faster and more intense effects in treating depression.
What safety data exists for individualized TMS for depression?
The safety data for individualized TMS, including aiTBS and SAINT, indicates that these treatments have similar safety profiles to traditional high-frequency rTMS. Studies show that iTBS and its variants are generally well-tolerated, with some participants experiencing tolerability issues. Meta-analyses suggest comparable safety and acceptability between iTBS and HF-rTMS for treatment-resistant depression. However, optimal parameters for these protocols are still under investigation.
134810Is aiTBS a promising treatment for depression?
Yes, aiTBS is a promising treatment for depression. It can shorten the time it takes for patients to feel better, and it is quicker to administer than traditional methods. This makes it a valuable option for people with depression.
23589What data supports the idea that Individualized TMS for Depression is an effective treatment?
The available research shows that Individualized TMS for Depression, specifically using theta burst stimulation (TBS), can be effective. One study found that TBS was as effective as traditional high-frequency TMS in treating depression, even in cases where other treatments had failed. Another study highlighted that accelerated TMS could shorten the time it takes for patients to feel better. However, the effectiveness can vary, as seen in a case series where only a small number of participants achieved significant improvement. Overall, while TMS shows promise, its effectiveness can depend on the specific protocol used and the individual patient.
13678Do I have to stop taking my current medications for the trial?
No, you don't have to stop taking your current medications. You need to have a stable antidepressant medication regimen for 4 weeks before the treatment and stay on it throughout the study.
Eligibility Criteria
This trial is for adults with major depressive disorder who haven't responded well to other treatments. They must speak English, maintain their usual caffeine intake, not use tobacco on treatment days, and avoid alcohol before MRI and TMS sessions. Pregnant individuals or those trying to become pregnant cannot participate.Participant Groups
The study tests aiTBS (a type of brain stimulation) for depression treatment effectiveness. Participants will receive aiTBS without knowing if the targeted area was chosen using neuroimaging or standard head measurements.
2Treatment groups
Experimental Treatment
Group I: sham individualized resting state functional connectivity targetingExperimental Treatment1 Intervention
Participants in this group will receive aiTBS with neuronavigation to a treatment target identified with head measurements (i.e., Beam F3)
Group II: real individualized resting state functional connectivity targetingExperimental Treatment1 Intervention
Participants in this group will receive aiTBS with neuronavigation to a treatment target identified with individualized resting state functional connectivity.
aiTBS is already approved in United States for the following indications:
🇺🇸 Approved in United States as aiTBS for:
- Treatment-resistant depression
- Major depressive disorder
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
References
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.
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 rTMS: A Potential Treatment to Alleviate Refractory Depression. [2020]Three decades of clinical research on repetitive transcranial magnetic stimulation (rTMS) has yielded one clear treatment indication in psychiatry for major depression disorder (MDD). Although the clinical response equals the standard treatment algorithms, the effect sizes on the beneficial outcome remain rather modest. Over the last couple of years, to improve the efficacy in resistant depression, two new avenues have been developed: personalization and intensifying rTMS treatment. For the latter, we retrospectively compared accelerated high-frequency rTMS (arTMS) with accelerated intermittent theta burst stimulation (aiTBS) in the refractory depressed state. Although the clinical efficacy was not significantly different between both protocols, our observations substantiate the potential of the accelerated stimulation to shorten the treatment duration from the depressed state to the response state. Any time gain from the depressed state to the recovered state is in the patients' interest.
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.
Critical role of rhythms in prefrontal transcranial magnetic stimulation for depression: A randomized sham-controlled study. [2022]Repetitive transcranial magnetic stimulation (rTMS) is an alternative treatment for depression, but the neural correlates of the treatment are currently inconclusive, which might be a limit of conventional analytical methods. The present study aimed to investigate the neurophysiological evidence and potential biomarkers for rTMS and intermittent theta burst stimulation (iTBS) treatment. A total of 61 treatment-resistant depression patients were randomly assigned to receive prolonged iTBS (piTBS; N = 19), 10 Hz rTMS (N = 20), or sham stimulation (N = 22). Each participant went through a treatment phase with resting state electroencephalography (EEG) recordings before and after the treatment phase. The aftereffects of stimulation showed that theta-alpha amplitude modulation frequency (fam ) was associated with piTBS_Responder, which involves repetitive bursts delivered in the theta frequency range, whereas alpha carrier frequency (fc ) was related to 10 Hz rTMS, which uses alpha rhythmic stimulation. In addition, theta-alpha amplitude modulation frequency was positively correlated with piTBS antidepressant efficacy, whereas the alpha frequency was not associated with the 10 Hz rTMS clinical outcome. The present study showed that TMS stimulation effects might be lasting, with changes of brain oscillations associated with the delivered frequency. Additionally, theta-alpha amplitude modulation frequency may be as a function of the degree of recovery in TRD with piTBS treatment and also a potential EEG-based predictor of antidepressant efficacy of piTBS in the early treatment stage, that is, first 2 weeks.
Intermittent theta burst stimulation (iTBS) versus 10 Hz high-frequency repetitive transcranial magnetic stimulation (rTMS) to alleviate treatment-resistant unipolar depression: A randomized controlled trial (THETA-DEP). [2022]Recently intermittent theta burst stimulation (iTBS) proved to be non-inferior to conventional repetitive transcranial magnetic stimulation (10 Hz rTMS) in unipolar depression after failure of one antidepressant trial, but to date no randomized control trial assessed the ability of iTBS to improve depression level and quality of life in more resistant features of depression with a long-term (6 month) follow-up in comparison to 10 Hz rTMS.
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.
Intermittent theta burst stimulation vs. high-frequency repetitive transcranial magnetic stimulation for major depressive disorder: A systematic review and meta-analysis. [2023]Our meta-analysis demonstrated that intermittent theta burst stimulation (iTBS)/bilateral-TBS (Bi-TBS) and high-frequency repetitive transcranial magnetic stimulation (HF-rTMS)/bilateral-rTMS (Bi-rTMS) had similar efficacy, acceptability, and safety profiles for antidepressant treatment-resistant major depressive disorder (AD-TRD). In our sensitivity analysis that excluded a study that compared Bi-TBS with Bi-rTMS for older adults, all efficacy outcomes were also comparable between iTBS and HF-rTMS. Because iTBS does not require higher stimulation intensity and a longer stimulus time than conventional HF-rTMS protocols, we speculated that for those with AD-TRD, iTBS/Bi-TBS is a more helpful therapeutic modality in clinical practice than HF-rTMS/Bi-rTMS.