RecruitingNAINTERVENTIONAL

Transcranial Magnetic Stimulation for Psychological Distress in Patients With Advanced Illness

This research trial is for people with serious progressive illnesses who are experiencing significant sadness, worry, or distress, often called 'existential suffering'. Current treatments don't always work well or quickly enough for people nearing the end of life. The study is investigating a treatment called repetitive Transcranial Magnetic Stimulation (rTMS). This involves using magnetic pulses to stimulate specific areas of the brain. It's already used for severe depression. Researchers want to find out if rTMS is safe, effective, and acceptable for reducing emotional distress in this group of patients. They will also look for the best amount of treatment to give (the dose) and how well people respond.

At a glance

Status

Recruiting

Phase

Sponsor

Ottawa Hospital Research Institute

Enrolment target

Start

02 Nov 2020

Estimated completion

20 Jan 2025

Depressive Symptoms Depression, Anxiety Psychological Distress Terminal Illness

What is this study about?

For people living with a serious, progressive illness, it's common to experience feelings of sadness, anxiety, and a deep sense of distress about their condition and what lies ahead. These feelings can make life very difficult and affect their overall well-being. Sometimes, these emotional struggles are so strong that they become the main reason someone might consider ending their life sooner.

While there are some treatments available, like talking therapies or medication, they don't always work quickly or well for everyone, especially for those with less time. Some medications can also have side effects that make things harder. This means there's a real need for new treatments that can offer quick and effective relief from these difficult emotions.

This study is exploring a treatment called repetitive Transcranial Magnetic Stimulation, or rTMS. This technique uses magnetic pulses to gently stimulate certain parts of the brain. It's a treatment that is already approved and used for severe depression, and it doesn't involve surgery. Researchers believe that rTMS might be a good option for people with serious illnesses because it could work more quickly and have fewer side effects than some other treatments. The main goals are to find the safest and most effective dose of rTMS, and to see if patients find this treatment helpful and easy to accept.

Key takeaways

This study investigates a brain stimulation therapy (rTMS) for emotional distress in serious illness.
It aims to find the safest and most effective treatment dose.
The goal is to provide quick relief from sadness, anxiety, and overall distress.
rTMS is non-invasive and already used for severe depression.
Participation involves screening and regular rTMS sessions, with close monitoring.
You can stop participating at any time without affecting your care.

Who may be eligible?

This study is looking for adults who are receiving care for a serious, progressive illness, either in a hospital's palliative care unit or at home, and are expected to live for at least another month. To take part, you would need to be experiencing noticeable feelings of sadness, anxiety, or generally feeling unwell emotionally, as measured by a simple symptom checker.

You also need to be able to understand and speak English. There are certain health conditions or implants that would prevent you from joining, such as having a history of seizures, metal in your head from old injuries or operations, any electronic devices inside your body like a pacemaker, or if you are pregnant. You also need to be able to sit still comfortably for the duration of the treatment session.

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 an adult receiving care for a serious, progressive illness?
Are you expected to live at least one more month?
Are you currently feeling significant sadness, anxiety, or emotional distress?
Can you understand and speak English?
Do you have any metal implants in your head or electronic devices in your body (like a pacemaker)?
Do you have a history of seizures or severe headaches, or are you pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step involves two checks to make sure rTMS is safe for you. One check will be done by you and the other by your doctor. If you're eligible, you'll receive rTMS treatments. This involves sitting in a chair while a magnetic coil is placed gently on your head. The treatment delivers magnetic pulses to specific areas of your brain.

During the first part of the study, researchers will be trying to find the best dose of treatment for you, and they will carefully watch how you respond. They'll also ask about your satisfaction with the treatment. The study will assess your symptoms before and after the rTMS sessions to see if there's an improvement in your emotional well-being. The total duration of your participation will depend on the study phase, but it's designed to be a relatively brief course of treatment.

Potential risks and benefits

Potential benefits of taking part could include a reduction in your feelings of sadness, anxiety, and overall emotional distress, potentially improving your quality of life. rTMS is generally considered safe, but like any medical treatment, there are potential risks. These are usually mild and can include temporary headache or discomfort during treatment. Very rarely, seizures can occur. You will be carefully monitored throughout the study, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Elisabeth Bruyère Hospital
Verified postcode
Ottawa, Canada· Recruiting

Common questions

What is 'rTMS'?

rTMS stands for repetitive Transcranial Magnetic Stimulation. It's a non-invasive treatment that uses magnetic pulses to stimulate specific areas of your brain to help improve mood.

Is rTMS painful?

Most people describe rTMS as causing a tapping sensation on the head, which can sometimes be uncomfortable or cause a mild headache, but it is not generally considered painful.

How long does each treatment session last?

The study aims for brief sessions, but the exact duration will be determined during the study to find the most effective and acceptable length for patients.

What kind of serious illnesses are included?

This study is for people with any advanced, terminal illness who are receiving palliative care and are experiencing significant emotional distress.

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

The first part of the study is 'open-label,' meaning you'll know you're getting the active rTMS. If the study progresses to a later phase, it might involve comparing the treatment to a 'sham' (dummy) version to see its true effect.

How to find out more

James Downar, MDCM, MHSc

jdownar@toh.ca 6135626262 Official trial record

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