Brain Stimulation for Depression and Anxiety

(PORT Trial)

Overseen By Jessica Layton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Schizophrenia, Bipolar I, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{2 3 4 6 7}

Who 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

able to adhere to the treatment schedule;

pass the TMS adult safety screening (TASS) questionnaire

I haven't started or increased any mental health medications in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intermittent theta-burst stimulation (iTBS) or low frequency repetitive transcranial magnetic stimulation (LFR) for depression and anxiety outcomes

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• rTMS

Trial Overview

The study is testing two types of brain stimulation: intermittent theta-burst stimulation (iTBS) versus low frequency repetitive transcranial magnetic stimulation (LFR). It aims to see which is more effective for improving symptoms of depression and anxiety in patients who haven't responded well to other treatments.

How Is the Trial Designed?

Group I: Low Frequency Right (LFR) Active Control 1 Intervention

1Hz stimulation to the R-DLPFC

Group II: Intermittent Theta Burst Stimulation (iTBS) Active Control 1 Intervention

iTBS to the L-DLPFC

rTMS is already approved in United States, European Union for the following indications:

Approved in United States as rTMS for:

• Obsessive-Compulsive Disorder (OCD)
• Major Depressive Disorder
• Migraines
• Smoking cessation

Approved in European Union as rTMS for:

• Obsessive-Compulsive Disorder (OCD)
• Major Depressive Disorder

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12243985/

Depression and anxiety outcomes of adults undergoing ...

Study reviewed iTBS outcomes for MDD patients, finding a depression response rate of 38.1% and remission rate of 9.5%. •. iTBS response rate was lower compared ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0006322325013563

Efficacy and Safety of Accelerated Intermittent Theta-burst ...

A-iTBS is a safe and effective treatment for adolescents with non-treatment-resistant MDD, but the therapeutic effect diminished at the month 3 ...

3.

nature.com

nature.com/articles/s41380-024-02630-5

Theta burst stimulation for depression: a systematic review ...

Our results suggest that iTBS (L-DLPFC) had a favorable risk-benefit balance for the treatment of depression because iTBS (L-DLPFC) had a high ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39761754/

Efficacy study of intermittent theta burst stimulation(iTBS) in ...

Compared to the sham group, patients in the active iTBS group showed significant improvement in depressive symptoms over the two days of ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07033780

NCT07033780 | Theta-Burst Stimulation to Treat Depression

The goal of this clinical trial is to explore the effects of non-invasive brain stimulation protocols using intermittent theta-burst stimulation (iTBS) on ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10423820/

Efficacy and safety of intermittent theta burst stimulation ...

The antidepressant effects and safety of iTBS and HF-rTMS appeared to be similar for patients with TRD, although additional RCTs with rigorous ...

7.

bmcpsychiatry.biomedcentral.com

bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-023-05470-9

A randomized sham-controlled trial of high-dosage ...

These long treatment sessions and courses result in two major drawbacks to rTMS: high cost and low capacity. Intermittent theta burst ...