RecruitingNAINTERVENTIONAL

Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults

This research study is for people over 60 who are experiencing both depression and early memory problems, such as Mild Cognitive Impairment or early Alzheimer's disease. It focuses on individuals whose depression hasn't responded well to standard antidepressant medications or who couldn't tolerate them. The study uses a special type of brain stimulation, called Deep TMS (Transcranial Magnetic Stimulation), which uses magnetic pulses delivered to a specific part of the brain to help improve mood. Researchers want to find out if this treatment is safe and effective in reducing symptoms of depression in this group. They will also look at how it might affect thinking and memory.

At a glance

Status

Recruiting

Phase

Sponsor

Rotman Research Institute at Baycrest

Enrolment target

Start

23 Oct 2018

Estimated completion

15 Sep 2026

Major Depressive Disorder Alzheimer Disease Mild Cognitive Impairment

What is this study about?

This study is looking into a treatment called Deep Transcranial Magnetic Stimulation (or Deep TMS) for people over 60 who have both depression and early stages of memory problems, like Mild Cognitive Impairment or early Alzheimer's disease. Researchers are especially interested in those whose depression hasn't improved with regular antidepressants or who couldn't take those medications.

Deep TMS uses a special device placed on the head that sends gentle magnetic pulses to a specific area of the brain known to be involved in mood. The aim is to see if this treatment can help reduce symptoms of depression in these individuals. Importantly, the researchers also want to make sure the treatment is safe and well-tolerated.

The study involves having this stimulation treatment for four weeks. After that, they will check back after another four weeks to see if the improvements last and to understand how the treatment might affect memory and thinking skills. There's also an option to try a slightly different, milder version of TMS treatment.

Key takeaways

This study explores a new brain stimulation treatment (Deep TMS) for depression.
It's for people over 60 who also have early memory problems or Alzheimer's.
Specifically focuses on those whose depression hasn't responded to usual medication.
Involves daily treatments for four weeks, with a follow-up check-up.
Aims to understand if the treatment is safe, helps mood, and affects thinking.
You have the option to try a milder TMS version too.

Who may be eligible?

To be part of this study, you would generally need to be over 60 years old and have been diagnosed with both depression and either early Alzheimer's disease or a milder form of memory loss called Mild Cognitive Impairment. It's important that your depression hasn't gotten better with antidepressant medicines, or that you couldn't take them for some reason. You'll also need to be able to understand and agree to take part, and have a close friend or family member who can help with some questionnaires.

There are also some important reasons why you might not be able to join. For example, if you have certain metal implants in your head (like a pacemaker or some ear implants), have a history of seizures, certain heart problems, or a history of specific mental health conditions like bipolar disorder or schizophrenia, you wouldn't be able to participate. You also shouldn't be pregnant or breastfeeding. The medical team will carefully check all these points to ensure your safety.

It's also required that you haven't recently used alcohol or drugs excessively, and if you're taking any regular medications, they need to have been stable for at least two months and not expected to change during 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 over 60 years old?
Have you been diagnosed with depression and also have early memory loss or Alzheimer's?
Has your depression not improved with regular antidepressants, or could you not take them?
Do you have a close friend or family member who can help with study questions?
Do you NOT have metal implants in your head (like a pacemaker or some ear implants)?
Do you NOT have a history of seizures, certain heart problems, or specific mental health conditions like bipolar disorder?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive Deep TMS treatment every day for four weeks. This involves visiting the clinic for each treatment session. The magnetic pulses are delivered by a special device placed on your head.

Throughout the study, the research team will regularly check your mood using a specific scale and also assess your thinking and memory skills with some tests. These assessments will help them understand how the treatment is affecting you. After the four weeks of daily treatment, you'll have a follow-up visit about four weeks later to see how you're doing. This visit will be about eight weeks after you first started the study. You will also have the option to try a milder version of TMS for four weeks.

Potential risks and benefits

A potential benefit of taking part in this study is that the Deep TMS treatment might help to improve your symptoms of depression, especially if other treatments haven't worked for you. It's also possible that it could have a positive effect on your thinking and memory. However, as with any medical procedure, there are potential risks. The most common side effects of TMS are usually mild and temporary, such as headache or discomfort at the treatment site. More rarely, there's a very small risk of seizure. The research team will carefully monitor you throughout the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Rotman Research Institute at Baycrest
Verified postcode
Toronto, Canada· Recruiting

Common questions

What exactly is Deep TMS?

Deep TMS is a treatment that uses magnetic fields to gently stimulate specific areas of the brain to help improve mood and reduce depression symptoms.

Will this treatment affect my memory?

The study will specifically look at how the treatment affects thinking and memory. Researchers want to understand if it helps or has any impact on these abilities.

How long does the treatment last each day?

The study involves daily treatment sessions for four consecutive weeks. The exact length of each session will be explained by the study team.

What if my depression doesn't get better?

This is a research study to see if the treatment works. While it might help, there's no guarantee your symptoms will improve. The team will discuss your options if this happens.

Do I have to stop my current medications?

Generally, you need to be stable on your medications for at least two months before starting the study, and not plan to change them during the study period. Your doctor will advise if any specific medications are a concern.

How to find out more

Amanda Rahmadian, BSc

dtms@research.baycrest.org 416-785-2500 Official trial record

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