Brain Stimulation for Depression and Anxiety
(PORT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate how two types of brain stimulation, iTBS and LFR, help with depression and anxiety. Both treatments use magnetic pulses to stimulate specific brain areas without invasive procedures. The study targets individuals whose depression hasn't improved with other treatments. Those experiencing depression that doesn't respond to standard medications and haven't changed their medications in the last month might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore new treatment options for those seeking alternatives to traditional therapies.
Will I have to stop taking my current medications?
The trial requires that if you are taking psychotropic medication, you must be on a stable dose for 4 weeks before starting treatment, and you cannot start any new regular psychotropic medication.
What prior data suggests that these brain stimulation techniques are safe for treating depression and anxiety?
Research shows that both treatments in this trial, low frequency repetitive transcranial magnetic stimulation (LFR) and intermittent theta-burst stimulation (iTBS), are generally safe for people with depression unresponsive to other treatments.
Several studies have tested low frequency rTMS, confirming its safety with only mild side effects that do not seem to affect cognitive abilities. Research has found it can be as effective as some common antidepressants.
Intermittent theta-burst stimulation (iTBS) is also considered safe. The FDA approved it in 2018 for treating depression, indicating it meets specific safety standards. Some studies show that iTBS works as well as other types of rTMS.
In summary, both LFR and iTBS are well-tolerated and show promise as safe options for those with treatment-resistant depression.12345Why are researchers excited about this trial?
Researchers are excited about these brain stimulation treatments for depression and anxiety because they offer new ways to target specific brain areas involved in these conditions. Unlike traditional medications that affect the whole brain, the Low Frequency Right (LFR) treatment uses 1Hz stimulation to the right dorsolateral prefrontal cortex (R-DLPFC), potentially leading to fewer side effects. The Intermittent Theta Burst Stimulation (iTBS) targets the left dorsolateral prefrontal cortex (L-DLPFC) with short bursts of high-frequency stimulation, which might provide faster relief. These techniques allow for precise targeting of brain regions associated with mood regulation, offering hope for those who haven't responded well to other treatments like antidepressants or psychotherapy.
What evidence suggests that this trial's treatments could be effective for depression and anxiety?
Research has shown that low-frequency repetitive transcranial magnetic stimulation (rTMS), a treatment available in this trial, can be very effective for individuals with depression unresponsive to other treatments. In one study, 87.8% of participants experienced a reduction in their depression symptoms. This treatment also helps reduce anxiety.
Another option in this trial is intermittent theta-burst stimulation (iTBS). Some studies have found that iTBS improved depression symptoms in 38.1% of participants. Both treatments have proven effective for depression and anxiety, each offering distinct benefits.23467Who Is on the Research Team?
Fidel Vila-Rodriguez, MD, PhD
Principal Investigator
University of British Columbia
Are You a Good Fit for This Trial?
This trial is for adults over 18 with treatment-resistant depression, scoring ≥26 on the IDS-30-SR. Participants must not have changed or started new psychotropic medications in the last 4 weeks and must be able to follow the treatment schedule. They should pass a safety screening and consent voluntarily.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either intermittent theta-burst stimulation (iTBS) or low frequency repetitive transcranial magnetic stimulation (LFR) for depression and anxiety outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- rTMS
rTMS is already approved in United States, European Union for the following indications:
- Obsessive-Compulsive Disorder (OCD)
- Major Depressive Disorder
- Migraines
- Smoking cessation
- Obsessive-Compulsive Disorder (OCD)
- Major Depressive Disorder
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor