RecruitingNAINTERVENTIONAL

Multi-session fMRI-Neurofeedback in PTSD

This research is investigating a new way to help people who have Post-Traumatic Stress Disorder (PTSD). PTSD can be very challenging, and this study explores whether a method called 'neurofeedback' can make a difference. Neurofeedback uses an MRI scanner to show people their brain activity in real-time. The idea is that by seeing this activity, they can learn to control certain brain areas that are linked to PTSD symptoms. The study will involve several neurofeedback sessions and will compare different brain areas targeted, as well as a 'sham' (fake) treatment, to see if this approach can reduce PTSD symptoms and change how brain parts connect. It builds on earlier, smaller studies to understand if this could be a helpful treatment.

At a glance

Status

Recruiting

Phase

Sponsor

Andrew Nicholson

Enrolment target

Start

01 May 2023

Estimated completion

01 Sep 2025

Post Traumatic Stress Disorder

What is this study about?

This study is looking into new ways to help people who have Post-Traumatic Stress Disorder, known as PTSD. PTSD is a mental health condition that can develop after someone experiences or witnesses a very frightening or upsetting event. It can cause a lot of distress and difficulty in daily life.

Researchers believe that in people with PTSD, certain parts of the brain don't work in the typical way. This study wants to see if we can help people with PTSD learn to manage these brain activity patterns. They will use a special type of MRI scan, called fMRI, which can show brain activity as it happens. This technique, called neurofeedback, gives participants a 'live' look at their brain. The hope is that by seeing their brain activity on a screen, they can learn to control it, which might in turn help to reduce their PTSD symptoms.

This research is important because it's trying to find new and effective treatments for PTSD. It's building on earlier work and will involve several sessions to get a clearer picture of whether this approach can really make a difference. The study will also compare targeting different brain areas and include a 'sham' (fake) treatment to ensure any improvements are truly due to the neurofeedback.

Key takeaways

This study explores a new brain-based treatment for PTSD.
It uses MRI neurofeedback to help people learn to control their brain activity.
Participants will have multiple MRI sessions and complete questionnaires.
The study aims to see if this can reduce PTSD symptoms.
It helps researchers understand how the brain works with PTSD.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old and speak English fluently. You also need to be comfortable using electronic devices like a smartphone or tablet. Importantly, you must have a clear diagnosis of PTSD, based on specific medical guidelines, and be able to understand and agree to take part in the study.

There are several reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you have certain serious medical conditions like heart problems, kidney issues, or unstable diabetes. You also can't have any metal implants in your body that would make an MRI scan unsafe, or a history of specific brain problems like a stroke or seizures. If you have been diagnosed with certain mental health conditions like bipolar disorder, psychosis, or schizophrenia, or if you are currently dealing with serious substance use issues, or have considered harming yourself recently, you would also not be able to participate.

Other reasons for not being able to join include having severe claustrophobia (a fear of tight spaces), or if you have already had certain types of brain treatments like neurofeedback or biofeedback before. Also, if you are currently doing a specific type of therapy focused on trauma, you wouldn't be able to take part.

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?
Do you have a diagnosis of PTSD?
Are you comfortable with MRI scans (no claustrophobia or metal in your body)?
Are you able to speak fluent English?
Do you have any serious, unstable medical conditions?
Are you currently receiving active trauma-focused therapy?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, here's what you can expect:

* **Initial Check-up:** You'll have a meeting with the study team to confirm you meet all the requirements. This will include talking about your medical history and PTSD symptoms. * **Questionnaires:** You'll fill out some questionnaires about your symptoms and life experiences. Some of these will be done online through a secure website. * **MRI Neurofeedback Sessions:** You'll have three special MRI scans. During these scans, you'll get real-time feedback on your brain activity. Each session will likely last for a while, and immediately after the last one, you'll have a chat with a trained professional about your experience. * **Activity Tracking:** For about 7 weeks, you'll wear a small device, similar to a smartwatch, to keep track of your sleep patterns and how active you are. * **No new medications are involved**, but current medications will be assessed to ensure they do not interfere with the study. The total duration of active participation, including assessments and scans, is spread out over several weeks, with the main neurofeedback sessions concentrated in a shorter period and then followed by the activity tracking.

Potential risks and benefits

Taking part in a study like this might have potential benefits. You might learn more about your condition, contribute to new knowledge about PTSD treatments, and you might experience a reduction in your symptoms, although this is not guaranteed as it is a research study. Potential risks include the minor discomfort and noise associated with an MRI scan, and the possibility that the treatment might not be effective for you. There is always a risk that discussing trauma-related words might cause temporary distress, but the researchers will try to keep this mild. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Lawson Health Research Institute
Verified postcode
London, Canada· Recruiting

Common questions

What is neurofeedback?

Neurofeedback uses special equipment, like an MRI scanner, to show you your brain activity in real-time. The idea is to help you learn to control certain brain patterns.

Will I have to stop my current PTSD treatment?

You cannot be doing active trauma-focused therapy when you join. Other treatments will be reviewed by the study team to see if they might affect the study.

Is an MRI scan safe?

Yes, MRI scans are generally very safe. However, they use strong magnets, so you cannot have any metal in or on your body that might be affected by the magnet.

What's a 'sham' treatment?

A 'sham' treatment is a fake treatment that looks like the real one but isn't designed to have a medical effect. It helps researchers compare the real treatment's effects.

How long will the study last?

The active part of the study, including assessments and MRI sessions, will be over a few weeks, followed by about 7 weeks of wearing an activity tracker.

How to find out more

Andrew A Nicholson, PhD

dr.andrewnicholson@gmail.com 437-349-9324 Official trial record

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