RecruitingNAINTERVENTIONAL

Comparing the Efficacy of fMRI-Guided vs. Standard iTBS in Treating Depression

This study is testing a new way to deliver a type of brain stimulation called iTBS, which is used to treat depression. Currently, iTBS helps about half the people who try it. We think we can make it even better by tailoring where we focus the stimulation in each person's brain, rather than using a standard spot. We'll compare this personalised method with the usual one. Participants will have an MRI scan, then receive 6 weeks of iTBS treatment. We want to see if the personalised approach improves how much people's depression symptoms get better, and if it leads to more people feeling well again.

At a glance

Status

Recruiting

Phase

Sponsor

The Royal Ottawa Mental Health Centre

Enrolment target

210

Start

16 Sep 2024

Estimated completion

01 Oct 2027

Depression Depressive Disorder, Major Depressive Episode

What is this study about?

This research is looking for better ways to treat depression using a method called repetitive Transcranial Magnetic Stimulation, or rTMS. It's a gentle, non-invasive treatment that uses magnetic pulses to stimulate specific areas of the brain. A newer, quicker version of this treatment is called intermittent Theta-Burst Stimulation, or iTBS. It only takes about 3 minutes per session, compared to 30-45 minutes for the older type, and it works just as well. Currently, about half the people who try rTMS find it helps their depression.

Doctors are always looking for ways to make treatments even more effective. In this study, we believe we might be able to improve iTBS by making it more personal. Instead of stimulating a standard area of the brain for everyone, we're testing if we can get better results by choosing a specific spot for each individual patient. We’ll do this by using a special type of brain scan called an fMRI to map out brain connections and then guide the iTBS treatment.

We will have two groups of participants. One group will receive iTBS to the usual, standard brain area. The other group will receive iTBS to a spot that's been specifically chosen for them based on their individual brain scan. By comparing these two groups, we hope to find out if this personalised approach makes iTBS work better, helping more people feel relief from their depression symptoms and improving their overall quality of life.

Key takeaways

This study explores a new, more personalised approach to treating depression.
It uses a brain stimulation method called iTBS, a quick and effective treatment.
The new method aims to tailor treatment to individual brain activity, potentially increasing effectiveness.
Participants will have an MRI scan and then receive 6 weeks of iTBS treatment.
The study compares a personalised treatment spot with the usual standard spot.
It seeks to improve response rates and overall well-being for people with depression.

Who may be eligible?

This study is open to adults aged 18 or older who have been diagnosed with moderate depression that hasn't fully improved with at least one antidepressant medication. You need to be able to speak and read English to take part.

We won't be able to include you if you have certain other conditions, like bipolar disorder, a recent history of serious substance or alcohol misuse (mild cannabis or alcohol use in the past 3 months might be okay), or if you are using illegal drugs. People with unstable medical problems, a known physical cause for their depression (like thyroid issues), or who are experiencing severe thoughts of harming themselves will also not be able to join. If you're over 65, you'll need a good memory score on a short test.

Crucially, you would already have been referred for rTMS treatment by your doctor and have made an informed decision to go ahead with this type of treatment. You also need to be able to attend all the scheduled appointments and have been on stable medication doses for at least a month before starting the study.

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 18 years old or older?
Have you been diagnosed with moderate depression that hasn't fully been helped by at least one antidepressant?
Are you able to speak and read English?
Have you already been referred for rTMS treatment by your doctor?
Do you feel generally healthy, without other major unstable medical concerns or a history of bipolar disorder?
Are you able to attend appointments regularly over 6 weeks?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll first have an MRI brain scan, which takes about 30-40 minutes. This scan helps us personalise the treatment. After that, you'll receive iTBS treatment sessions over 6 weeks. These sessions only last about 3 minutes each, but you'll need to attend regularly. You'll be randomly assigned to either receive the standard iTBS treatment or a new personalised version; you won't know which one you're getting, and neither will the study staff administering the treatment. Throughout the study, we will regularly check your depression and anxiety symptoms, ask about your quality of life, and use special devices to measure things like your heart rate, sleep patterns, and daily activity. You will continue to take any stable medications you are on, and the total duration of your active participation will be the 6 weeks of treatment.

Potential risks and benefits

Taking part in this study might offer you the benefit of receiving a potentially more effective, personalised treatment for your depression. While iTBS is generally safe and well-tolerated, like all medical treatments, there are some potential risks. These include minor side effects such as headaches or discomfort at the stimulation site, though serious side effects are rare. You will have multiple assessments which can be time-consuming. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

The Royal's Institute of Mental Health Research
Verified postcode
Ottawa, Canada· Recruiting

Common questions

What is iTBS?

iTBS is a type of brain stimulation treatment for depression that uses magnetic pulses to gently encourage brain activity in certain areas. It's a quicker version of a treatment called rTMS.

Will I know if I'm getting the personalised treatment?

No, this study is 'triple-blinded,' meaning you, the people giving the treatment, and the people analysing the results won't know whether you're receiving the standard or personalised treatment until the study is over.

Do I need to stop my current depression medication?

No, you should continue your current medications for depression, but they need to have been on a stable dose for at least four weeks before starting the study.

How long will the treatment sessions be?

Each iTBS treatment session is very short, lasting only about 3 minutes.

What is the MRI scan for?

The MRI scan helps us create a detailed map of your brain's connections. This map is then used to either guide your personalised treatment or to guide the standard treatment location, depending on which group you're in.

How to find out more

Stacey Shim, MSc

stacey.shim@theroyal.ca 613-722-6521 Official trial record

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