Accelerated Neuromodulation Therapy for Negative Symptoms of Schizophrenia
This study explores a new, quick brain stimulation treatment for people living with schizophrenia who experience 'negative symptoms.' These symptoms can make it hard to feel motivated, express emotions, or connect with others, and current treatments don't always help enough. We're testing an accelerated therapy where stimulation is given over just five days, instead of many weeks, to see if it's safe, easy to cope with, and effective in reducing these negative symptoms. Participants will receive either the real stimulation or a dummy (placebo) treatment, and we'll compare two different ways of guiding where the stimulation goes on the brain. The aim is to gather information for future, larger studies to help more people.
At a glance
What is this study about?
This study is looking into a new way to help people with schizophrenia who experience what doctors call `negative symptoms`. These aren't about being negative or sad, but more about things that feel 'missing.' For example, someone might have trouble feeling motivated, showing emotions, or finding it easy to socialise with others. These symptoms can be really challenging and often aren't fully helped by current treatments.
The main idea behind this study is to see if a special type of brain stimulation, called neuromodulation, can help. We're particularly interested in an `accelerated` version, meaning the treatment is given over a much shorter time – just five days – instead of many weeks. This quicker approach might make it easier for people to access and stick with the treatment. We want to find out if this accelerated treatment is safe, if people can tolerate it well, and importantly, if it improves these negative symptoms.
Participants will be split into different groups by chance. Some will receive the real brain stimulation, while others will get what's called `sham` stimulation, which feels similar but isn't active (like a placebo). We're also comparing two different methods for guiding where the stimulation is applied to the brain. This study is taking place in Canada and will help us understand if this treatment is promising enough to test in bigger studies later on.
Key takeaways
- The study is investigating a new, faster brain stimulation treatment for schizophrenia.
- It focuses on 'negative symptoms' like low motivation and reduced emotional expression.
- Treatment involves five consecutive days of brain stimulation or a dummy treatment.
- The aim is to see if it's safe, tolerable, and improves symptoms.
- Researchers are also comparing different ways of guiding where the stimulation is applied.
- Your involvement would include assessments, scans, treatment, and follow-up visits.
Who may be eligible?
To join this study, you would need to have a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder for at least six months. It’s important that you are experiencing noticeable negative symptoms that are causing you difficulties. Your current medication for these conditions should have been stable for at least four weeks, and your doctors should agree that your symptoms have been steady for at least three months.
You also need to be able to understand the study and agree to take part, and be able to have a detailed scan of your brain called an MRI.
There are some reasons why you couldn't join. For example, if you are pregnant or breastfeeding, or if you've had a type of brain therapy called ECT in the last six months. Also, if you use certain substances (apart from cannabis) during the treatment week or before brain scans, or if you have any medical conditions that would make the brain stimulation unsafe. If you have a severe learning disability or your mental health condition is mainly due to another medical problem or drug use, 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.
- Do you have a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder?
- Have you been experiencing significant negative symptoms?
- Has your current mental health medication been stable for at least 4 weeks?
- Are you between 18 and 65 years old?
- Are you able to have an MRI brain scan?
- Are you not pregnant or breastfeeding?
What does participation involve?
If you decide to take part, you'll first have some assessments, including interviews, answering questionnaires, and having a brain scan. Then, you'll receive either the real brain stimulation or a dummy treatment for five days in a row. After the treatment, you'll have follow-up visits to see how you're doing. The total duration of your involvement, from the first check-ups to the last follow-up, will be outlined to you. You would need to keep your current medications stable throughout the study. You will not be able to use certain substances during the treatment week and before brain scans.
Potential risks and benefits
Locations (3)
- Institut Universitaire en Santé Mentale de MontréalVerified postcodeMontreal, Canada· Not yet recruiting
- Institut universitaire de santé mentale de Québec - Centre de recherche CERVOVerified postcodeQuébec, Canada· Not yet recruiting
- McGill Lab for Computational Psychiatry and Translation - Burland Pavilion 6875 Boulevard LaSalle Montreal, QCVerified postcodeVerdun, Canada· Recruiting
Common questions
What are 'negative symptoms'?
These are symptoms where something seems 'missing,' like low energy, reduced expression of feelings, or finding it hard to get motivated or socialise.
What is neuromodulation therapy?
It's a type of brain stimulation that uses gentle magnetic pulses to encourage certain brain cells to work better, aiming to improve symptoms.
Will I know if I'm getting the real treatment or the dummy one?
No, you won't know initially. This helps us fairly compare the effects of the real treatment against no active treatment.
How long will I need to be at the hospital?
You'll need to attend for assessments, brain scans, the five consecutive days of treatment, and then follow-up visits. The staff will provide a detailed schedule.
Will I have to pay to join the study?
No, participation in the study is free. Any study-related assessments and treatments are provided at no cost to you.
How to find out more
Ashley S. Choucroun
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.