Rapid-Acting TMS for Depression
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.
Will I have to stop taking my current medications?
No, you will not have to stop taking your current medications. Participants must be on a stable antidepressant regimen for 6 weeks before joining the study and agree to continue it throughout the study.
What data supports the effectiveness of the treatment TBS-DLPFC for depression?
Research shows that intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation (TMS), is effective for treating major depression. Studies indicate that iTBS can be as effective as traditional TMS but is delivered in a shorter time, making it a promising option for patients with treatment-resistant depression.12345
Is rapid-acting TMS for depression safe for humans?
Theta burst stimulation (TBS), a form of transcranial magnetic stimulation (TMS), is generally considered safe, with most side effects being mild and occurring in about 5% of people. However, there is a small risk of seizures, so it should be used carefully, especially since it's a newer technique.46789
How is the TBS-DLPFC treatment for depression different from other treatments?
TBS-DLPFC (Theta-Burst Stimulation) is a unique treatment for depression because it uses magnetic pulses to stimulate the brain in a very short time, just over 3 minutes, compared to traditional methods that take much longer. This makes it a faster option for patients, and it can be used in accelerated schedules, although the best settings for its use are still being studied.124710
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
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive accelerated theta-burst TMS stimulation or sham treatment for 4-8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- TBS-DLPFC (Transcranial Magnetic Stimulation)
TBS-DLPFC is already approved in United States, European Union, Canada for the following indications:
- Treatment-Resistant Depression
- Major Depressive Disorder
- Treatment-Resistant Depression
- Depression
- Anxiety Disorders