RecruitingNAINTERVENTIONAL

Efficacy of Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) in Auditory Verbal Hallucinations

This research is investigating a treatment called repetitive transcranial magnetic stimulation (rTMS) for people who experience auditory verbal hallucinations, often known as 'hearing voices,' as a symptom of schizophrenia or psychosis. While rTMS has shown promise in reducing these voices for a short time, this study aims to see if having regular 'maintenance' rTMS sessions can make the positive effects last much longer. Participants will receive either the actual rTMS treatment or a 'sham' (inactive) version. Researchers will closely monitor how effective this maintenance approach is over several months and will also look for factors that might predict who benefits most from the treatment.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Caen

Enrolment target

120

Start

30 Oct 2023

Estimated completion

30 Nov 2027

Schizophrenia; Psychosis

What is this study about?

This study is about helping people who experience auditory verbal hallucinations, which means hearing voices that aren't real. These voices can be a challenging symptom for individuals with conditions like schizophrenia or psychosis. A treatment called repetitive transcranial magnetic stimulation, or rTMS, has been shown to help some people with these voices. rTMS is a treatment that uses magnetic pulses to gently stimulate specific areas of the brain.

Previous research has shown that a short course of rTMS can quickly reduce how often and how intensely people hear these voices. However, the benefits might not always last a very long time. This new study wants to find out if having regular 'top-up' rTMS sessions after the initial treatment can help the positive effects last for many months. Imagine it like getting a booster shot for a vaccine – it helps keep the protection going. The study will also try to discover if there are any particular signs or characteristics that predict who will respond best to this type of treatment.

To do this, some people will receive the actual rTMS treatment combined with these regular maintenance sessions, while others will receive a 'sham' treatment, which feels like the real thing but doesn't actually stimulate the brain. This helps the researchers accurately compare the effects of the active treatment. Everyone involved, including the patients and their doctors, won't know whether they're getting the active or sham treatment until the study is over, which is a common and important way to make research fair and accurate.

Key takeaways

This study evaluates regular 'top-up' rTMS treatments for hearing voices.
Aims to make the beneficial effects of rTMS last longer.
Participants will receive either active rTMS or an inactive 'sham' treatment.
The study lasts approximately five months, including regular treatment sessions and follow-up.
Researchers are also looking for predictors of treatment success.

Who may be eligible?

To join this study, you need to be between 18 and 65 years old. You must have a diagnosis of schizophrenia or a similar condition called schizoaffective disorder, and you should be taking medication for it. You also need to have been experiencing auditory verbal hallucinations (hearing voices) for at least six weeks, even with your current medication, and your medication dose should have been stable for the same amount of time.

Some important things would prevent you from taking part. For example, if you are pregnant, or if you have certain metal implants in your body like a pacemaker, a brain stimulator, or some types of clips in your head, then rTMS wouldn't be safe for you. If a brain scan (MRI) showed any unusual brain problems, or if you couldn't commit to all the study appointments, you also wouldn't be able to join. You'll also need to understand French to participate, as the study is being conducted where French is the primary language, and be covered by a European health system.

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 schizophrenia or schizoaffective disorder?
Are you currently taking medication for your condition?
Have you been hearing voices for at least 6 weeks, despite your medication?
Do you have any metal implants (like a pacemaker) that would prevent rTMS or an MRI?
Can you understand French and commit to study appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have an intense treatment period over two days. This involves four rTMS sessions on each of those two days. After this initial treatment, you would then enter a 'maintenance phase' where you'd have two rTMS sessions every week for the first month, and then two sessions every two weeks for the following three months. In total, this means about 24 rTMS sessions over the four-month maintenance period.

Throughout the study, which lasts for about five months, you will have regular visits to monitor your symptoms and your general health. You will be assigned randomly to either receive the active rTMS treatment or a 'sham' (inactive) version, but you won't know which one you are getting. Researchers will also collect blood samples and take measurements to better understand how the treatment works and who might benefit most. Your medication dosage needs to remain stable throughout the study. You'll also have a brain scan (MRI) before starting, unless there's a medical reason you can't.

Potential risks and benefits

Taking part in this study may offer the potential benefit of reducing your auditory verbal hallucinations and making those improvements last longer. However, there's also a chance you might receive the 'sham' treatment, which would not have a direct therapeutic effect. As with any medical procedure, there are potential risks associated with rTMS, such as mild headaches, scalp discomfort, or in very rare cases, seizures, although precautions are taken to minimise these risks. Having an MRI scan also carries some risks, especially if you have certain metal in your body. You will be given full information about all potential risks during the consent process. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Caen University Hospital
Verified postcode
Caen, France· Recruiting

Common questions

What are auditory verbal hallucinations?

These are experiences of hearing voices, sounds, or noises that aren't actually there, but feel very real to the person experiencing them.

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 the brain.

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

No, neither you nor your doctors will know if you're getting the active rTMS or the sham (inactive) treatment until after the study is finished. This helps make the study fair.

How long will the treatment last?

The intense initial treatment lasts two days, followed by maintenance sessions for about four months. The total study follow-up period will be around five months.

What if I change my mind?

You are free to stop participating in the study at any time, for any reason, and it will not affect your usual medical care.

How to find out more

Sonia Dollfus, MD-PhD

dollfus-s@chu-caen.fr 02.31.06.50.18 Official trial record

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