RecruitingNAINTERVENTIONAL

Temporal Interference and Depression

This study is looking into a new way to treat severe depression using something called Temporal Interference (TI) stimulation. Many current treatments have side effects or don't work for everyone, so new options are urgently needed. TI stimulation uses very gentle electrical currents that interact deep in the brain to help improve mood. This treatment focuses on a specific part of the brain linked to depression. Researchers want to find out if TI stimulation is safe, well-tolerated, and effective for people with depression. Participants will have 10 sessions of either the real TI stimulation or a dummy (sham) treatment, each lasting 30 minutes, while watching short emotional videos. The study will check how their brains respond and if their depression symptoms get better.

At a glance

Status

Recruiting

Phase

Sponsor

Unity Health Toronto

Enrolment target

Start

15 May 2025

Estimated completion

01 Dec 2027

Major Depressive Disorder

What is this study about?

Many people struggle with depression, which can be a very challenging condition to live with. While there are treatments available, they don't always work for everyone, and some can have unpleasant side effects. This is why doctors and scientists are constantly searching for new, more effective, and gentler ways to help.

This study is investigating a new type of gentle brain stimulation called Temporal Interference (TI) stimulation. Imagine two very weak signals being sent into your brain, barely noticeable on their own. Where these signals meet, they create a special effect that can influence brain activity in a very targeted way. This is helpful because there's a deep part of the brain, called the subgenual cingulate cortex (SCC), that seems to play a key role in depression. Current non-invasive treatments find it hard to reach this deep area precisely, but TI stimulation might be able to.

Researchers will involve 30 people who have been diagnosed with major depression. For 10 days, participants will receive either the active TI stimulation or a 'sham' (dummy) treatment, which feels similar but doesn't have the active electrical effect. Each session will last about 30 minutes, during which participants will watch emotional film clips. The main goal is to see if this new treatment is safe, if people can easily tolerate it, and if it helps to improve symptoms of depression. The findings will be very important for developing this technology further and planning a larger study in the future.

Key takeaways

This study tests a new non-invasive brain stimulation for severe depression.
It aims to find out if Temporal Interference (TI) stimulation is safe and effective.
Participants will get either active TI or a dummy treatment for 10 days.
The treatment focuses on a deep brain area linked to depression.
Watching emotional films during sessions helps target the treatment.
Results will help design future, larger studies for depression treatments.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old and have a diagnosis of major depression without psychotic features, meaning without experiencing hallucinations or delusions. Your depression should be moderate to severe, as measured by a doctor's assessment.

It's important that you haven't started any new mental health medications or changed the dose of existing ones in the month before the screening visit. You must also be well and not have any other serious medical conditions like active hepatitis, HIV, or heart pace makers. We also can't include you if you're pregnant or breastfeeding, or if you have a current problem with alcohol or drug use, or specific conditions like autism or dementia. You also need to be able to fully understand and follow the study instructions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Have you been diagnosed with major depression (without psychosis)?
Is your depression currently moderate to severe?
Have you had no recent changes to your mental health medication (last 4 weeks)?
Are you free from certain other serious medical conditions or current substance abuse issues?
Are you able to attend daily sessions for 10 days?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to check if the study is right for you. If you qualify, you'll be randomly assigned to receive either the active TI stimulation or a 'sham' (dummy) stimulation. This means you won't know which one you're getting, and neither will the study team.

You'll have 10 sessions of stimulation, once a day for 10 consecutive days. Each session will last about 30 minutes, and during this time, you'll be watching short emotional film clips. There will also be some brain scans (like fMRI) and EEG recordings to help researchers understand how your brain responds to the treatment. You'll have regular check-ups to monitor your mood and well-being throughout the study. The total duration of your active participation, including follow-up, will be several weeks.

Potential risks and benefits

Participating in this research might offer potential benefits, such as receiving a novel depression treatment that could improve your symptoms. However, as this is a new treatment, there's no guarantee that it will be effective for you. Potential risks might include mild side effects from the stimulation, such as skin irritation or discomfort, which will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Interventional Psychiatry Program, St. Michael's Hospital - Unity Health Toronto
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is 'sham stimulation'?

Sham stimulation is like a 'dummy' treatment. It feels similar to the real stimulation but doesn't actually deliver the active electrical signals. This helps researchers compare the effects of the real treatment against not having the active treatment.

Will I know if I'm getting the real treatment or the dummy treatment?

No, neither you nor the study team will know whether you are receiving the active (real) stimulation or the sham (dummy) stimulation. This is standard practice in clinical trials and helps ensure the study results are unbiased.

What does a session involve?

Each session lasts about 30 minutes. You will have electrodes placed on your head, and then you'll receive either the active or sham stimulation while watching short emotional film clips.

Is this an invasive treatment?

No, Temporal Interference stimulation is considered non-invasive. It involves placing electrodes on the surface of your scalp and doesn't require any surgery or breaking of the skin.

What happens if my depression symptoms get worse during the study?

Your well-being will be monitored throughout the study. If your symptoms worsen or if there are any concerns, the study team will provide appropriate support and ensure you receive the necessary care.

How to find out more

Venkat Bhat, MD MSc

venkat.bhat@unityhealth.to 416-360-4000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.