Individualized TMS for Depression
(AINT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called accelerated intermittent theta burst stimulation (aiTBS) for individuals with major depressive disorder, a type of depression that resists usual treatments. The researchers aim to determine if brain scans can guide the treatment more effectively than standard head measurements. Participants will receive aiTBS without knowing which method determined their treatment spot. This trial suits individuals with major depression that hasn't improved despite consistent medication use for at least four weeks. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important early findings.
Do 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.
Will I have to stop taking my current medications?
No, you will not have to stop taking your current medications. Participants must have a stable antidepressant medication regimen for 4 weeks before the trial and continue it throughout the study.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that accelerated intermittent theta burst stimulation (aiTBS) is generally safe and well-tolerated. Studies have found that aiTBS, used to treat depression, does not cause major side effects. This treatment stimulates the brain externally, eliminating the need for surgery. Recipients of aiTBS reported rapid improvements in depression symptoms. Although further research is needed, current evidence suggests that aiTBS is a safe option for those considering this treatment.12345
Why do researchers think this study treatment might be promising for depression?
Researchers are excited about aiTBS for depression because it offers a personalized approach by using neuronavigation based on each individual's brain connectivity patterns. Unlike traditional depression treatments, which often involve medication or standard repetitive transcranial magnetic stimulation (rTMS), aiTBS targets specific brain areas identified through resting state functional connectivity. This could lead to more effective and faster results by precisely delivering magnetic pulses to the most relevant brain regions. Moreover, the use of aiTBS with neuronavigation aims to enhance the precision and efficacy of treatment, potentially reducing side effects and improving outcomes for individuals with depression.
What evidence suggests that this trial's aiTBS treatments could be effective for depression?
Research shows that accelerated intermittent theta burst stimulation (aiTBS) could benefit people with major depressive disorder. Studies have found that aiTBS can quickly reduce depression and suicidal thoughts in individuals whose depression hasn't improved with other treatments. In this trial, participants will receive either real aiTBS with neuronavigation to a treatment target identified through individualized resting state functional connectivity or a sham version using head measurements. One study found that a high-dose version of aiTBS, guided by brain imaging, was safe and easy for patients to handle. Another study showed that aiTBS could be as effective as traditional brain stimulation treatments, but in a much shorter time. Overall, aiTBS offers a fast-acting option for those dealing with severe depression.12346
Who Is on the Research Team?
Joseph J Taylor, MD, PhD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
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.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) with either real or sham individualized resting state functional connectivity targeting
Follow-up
Participants are monitored for safety and effectiveness after treatment, including MRI scans and various psychological assessments
What Are the Treatments Tested in This Trial?
Interventions
- aiTBS
aiTBS is already approved in United States for the following indications:
- Treatment-resistant depression
- Major depressive disorder
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor