Active not recruitingNAINTERVENTIONAL

Psilocybin in Functional Neurological Disorder

This study aims to understand how a single dose of psilocybin, a substance found in some mushrooms, affects the brains of people living with Functional Neurological Disorder (FND). Participants will receive the psilocybin along with therapeutic support. Researchers are particularly interested in how a specific brain network, called the default mode network – which is thought to play a role in FND – might change. They will use special brain scans (fMRI) before and after giving the psilocybin to see if this network can be altered. The main goal is to explore if psilocybin could help modify brain activity in FND.

At a glance

Status

Active not recruiting

Phase

Sponsor

King's College London

Enrolment target

Start

14 Feb 2024

Estimated completion

01 May 2026

Functional Neurological Disorder

What is this study about?

This research is looking into how a specific substance called psilocybin, which is found in certain types of mushrooms, might affect the brains of people who have Functional Neurological Disorder (FND). FND is a condition where people experience physical symptoms like weakness, tremors, or seizures, but these symptoms aren't caused by damage or disease in the brain or nervous system that doctors can see on typical scans.

The main idea behind this study is to see if a single dose of psilocybin, given with helpful support, can change how certain parts of the brain communicate. Scientists believe that a particular brain network, often called the 'default mode network,' might be working differently in people with FND. They want to find out if psilocybin can adjust this network's activity, which they will measure using special brain scans called fMRI, both before and after someone takes the psilocybin.

By understanding if and how psilocybin affects brain activity in FND, researchers hope to gain new insights into the condition itself. This understanding could, in the future, help in developing new ways to support and treat people living with FND. It's important to remember that this is an early-stage study to learn more about brain responses, not a study to test if psilocybin is a cure.

Key takeaways

This study investigates how psilocybin affects brain activity in FND.
It uses brain scans (fMRI) to look at a specific brain network.
Participants receive a single dose of psilocybin with therapeutic support.
It's for adults (25-60) with moderate to severe FND that hasn't responded to other treatments.
It's a research study to learn more about FND, not a direct treatment trial.

Who may be eligible?

To join this study, you need to be between 25 and 60 years old and speak English well. A doctor specialising in nerves (neurologist) or brain conditions (neuropsychiatrist) must have already diagnosed you with Functional Neurological Disorder (FND) and you should have had symptoms for over a year that haven't improved with other treatments.

Your FND symptoms should be considered moderate or severe, and you must be able to have an MRI scan, which involves lying still in a scanner. Failed treatment means you've tried therapies like talking therapy (cognitive behavioural therapy) or physiotherapy specifically for FND, given by an expert, and they haven't helped enough.

There are also some reasons why you wouldn't be able to join. These include having certain other mental health conditions like severe depression, bipolar disorder, psychosis (unless it was a short reaction to a substance), a history of severe drug or alcohol dependence, or certain personality disorders. Also, if you have dementia or a similar memory problem, 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 25 and 60 years old?
Have you been officially diagnosed with Functional Neurological Disorder (FND) by a specialist?
Have your FND symptoms been present for over a year and not improved with standard FND treatments?
Are your FND symptoms currently moderate or severe?
Are you able to have an MRI brain scan (lying still inside a scanner)?
Do you NOT have certain other mental health conditions like severe depression, bipolar disorder, or a history of severe drug/alcohol dependence?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a single dose of psilocybin. Throughout the study, you'll also receive therapeutic support to help you through the experience. You will have brain scans (fMRI) done before and after you take the psilocybin. The researchers will be collecting information about your brain activity and how your symptoms might change. The exact number of visits and the total length of your involvement will be clearly explained by the research team if you are eligible.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as contributing to new understanding of Functional Neurological Disorder, which might help future patients. You would also receive support from trained therapists. However, there are potential risks associated with psilocybin, including psychological effects like anxiety or confusion, though you will be supported by professionals throughout. As with any medical procedure, the MRI scans also carry very small risks. You have the right 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.

South London and Maudsley NHS Foundation Trust
Verified postcode
London, United Kingdom

Common questions

What is Functional Neurological Disorder (FND)?

FND is a condition where people experience physical symptoms like weakness or tremors, but these aren't caused by damage to the brain or nerves that doctors can normally see.

What is psilocybin?

Psilocybin is a substance found in certain types of mushrooms that can affect your mood, thoughts, and senses. It's sometimes called a 'psychedelic'.

Will I become addicted to psilocybin?

Psilocybin is generally not considered to be addictive. In this study, you'll receive only a single dose under close medical supervision.

What is an fMRI scan?

An fMRI is a special type of brain scan that looks at blood flow changes in the brain, helping researchers see which parts of your brain are active. It doesn't use radiation.

Will I feel better after taking psilocybin?

This study is mainly to understand how psilocybin affects the brain in FND, not to treat the condition. Any effects on your symptoms would be a secondary observation.