Individualized TMS for Depression
(AINT Trial)
Trial Summary
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.
What 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.12345
What data supports the effectiveness of the treatment aiTBS for depression?
Research shows that accelerated intermittent theta burst stimulation (aiTBS) can potentially shorten the time it takes for patients to move from a depressed state to a response state, which is beneficial for those with treatment-resistant depression. Additionally, aiTBS has been found to be as effective as traditional repetitive transcranial magnetic stimulation (rTMS) in treating major depression, with some studies suggesting it may have lasting effects on brain activity related to depression recovery.12345
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.12367
Is individualized TMS for depression safe for humans?
Is aiTBS a promising treatment for depression?
How is the aiTBS treatment for depression different from other treatments?
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.
Research Team
Joseph J Taylor, MD, PhD
Principal Investigator
Brigham and Women's Hospital
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.Inclusion Criteria
Exclusion Criteria
Timeline
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
Treatment Details
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