Neuronavigated aiTBS for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new methods for treating depression that hasn't improved with other treatments. It uses repetitive transcranial magnetic stimulation (rTMS), which involves magnets to stimulate the brain. The trial compares three groups: one with a personalized approach using MRI guidance, one with a standard approach, and a placebo group. One method under examination is aiTBS (accelerated intermittent Theta Burst Stimulation), a form of rTMS. Suitable participants have battled depression despite trying at least two different antidepressants or therapies. Participants must attend daily sessions for about three weeks. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for depression.
Do I need to stop my current medications for the trial?
You need to keep your antidepressant medication stable for at least 6 weeks before starting the trial and throughout the trial. However, you cannot use certain medications like anticonvulsants, psychostimulants, lithium, or high doses of benzodiazepines.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that intermittent theta burst stimulation (iTBS) received FDA approval in 2018 for major depression, indicating its general safety and tolerability. Studies have found that a faster version, accelerated iTBS (aiTBS), benefits those with treatment-resistant depression. While some reports raise concerns about the treatment's duration and safety, they lack detail. Overall, the treatment is considered safe due to FDA approval for similar conditions. No reports of serious side effects exist, which should reassure potential participants.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about this trial because it explores a new way of using aiTBS (accelerated intermittent Theta Burst Stimulation) to treat depression. Unlike standard treatments like medication and traditional therapy, this trial uses neuronavigation guided by MRI imaging to precisely target the brain areas involved in depression. This precision could enhance the effectiveness of aiTBS by ensuring the stimulation reaches the exact brain regions that need it. Additionally, this method could potentially offer quicker relief from depressive symptoms compared to traditional treatments, making it a promising option for patients seeking faster results.
What evidence suggests that this trial's treatments could be effective for treatment-resistant depression?
Research has shown that accelerated intermittent theta-burst stimulation (aiTBS) can help reduce depression symptoms. One study found aiTBS to be much more effective than a placebo in improving these symptoms. Another study demonstrated that aiTBS could quickly and safely aid people with depression by targeting specific brain areas. This trial will compare different methods of administering aiTBS: one group will receive Neuronavigated aiTBS, guided by MRI imaging, while another group will receive Non-Neuronavigated aiTBS, using conventional device placement. These findings suggest that aiTBS, with or without neuronavigation, could be a promising option for those dealing with depression.25678
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 with treatment-resistant depression, having tried maximum dose antidepressants for 6 weeks or completed at least 12 sessions of psychotherapy. Participants must have moderate to severe depression as measured by the MADRS score and be stable on their current medication for at least six weeks before starting the trial.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive neuronavigated aiTBS, non-neuronavigated aiTBS, or sham aiTBS for treatment-resistant depression
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- aiTBS
Trial Overview
The study tests neuronavigated accelerated intermittent theta-burst stimulation (aiTBS) against non-neuronavigated aiTBS and a sham procedure in treating major depressive disorder. It's a randomized controlled trial conducted across multiple centers to assess if neuronavigation improves outcomes in an accelerated treatment protocol.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Placebo Group
TBS device placement during treatment determined by MRI imaging
Conventional device placement during treatment
identical procedures as the other 2 groups but without turning on the device
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
University of California, San Diego
Collaborator
Cornell University
Collaborator
Citations
Accelerated Intermittent Theta-Burst Stimulation and ...
This randomized clinical trial assesses the effectiveness of accelerated intermittent theta-burst stimulation for depressive symptom reduction
NCT07329153 | Neuronavigated aiTBS for TRD
The purpose of this study is to confirm the efficacy of two recently introduced repetitive transcranial magnetic stimulation (rTMS) ...
Efficacy study of intermittent theta burst stimulation(iTBS) in ...
The current study suggests that two days of active iTBS to the DLPFC region can rapidly, safely, and effectively improve depressive symptoms in adolescents ...
Accelerated Intermittent Theta-Burst Stimulation for ...
They found that active aiTBS was significantly more effective than sham stimulation for depressive symptoms, supporting the clinical efficacy of ...
Connectivity-guided intermittent theta burst versus ... - Nature
MRI-neuronavigated cgiTBS and rTMS were equally effective in patients with treatment-resistant depression over 26 weeks.
Accelerated Theta Burst Stimulation (aTBS)
The conventional iTBS protocol is FDA-approved to treat otherwise treatment-resistant depression but the 6-week duration limits the applicability of this ...
Efficacy and Safety of Accelerated Intermittent Theta-burst ...
While 10-session daily accelerated intermittent theta burst stimulation (a-iTBS) is effective in adults, its duration and safety limit its use ...
Theta Burst Stimulation TMS Treatment: A Patient's Guide
Intermittent theta burst stimulation (iTBS) has been growing in popularity since receiving FDA approval for treating major depression in 2018.
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