Psilocybin-assisted Physiotherapy for motor Functional Neurological Disorder
Psilocybin-assisted Physiotherapy for refractory motor Functional Neurological Disorder – a randomised, controlled trial in participants with refractory motor Functional Neurological Disorder
The University of Melbourne
136 participants
Apr 22, 2026
Interventional
Conditions
Summary
Functional Neurological Disorder (or ‘FND’ for short) is a common condition in which patients develop neurological symptoms such as paralysis, tremor or seizures. However, FND is different to other neurological conditions such as stroke or multiple sclerosis because standard neurological investigations do not show abnormalities within the brain or nervous system that can explain the patient’s symptoms. FND symptoms often persist for many years and have a major impact on patients' quality of life. There is no effective treatment for FND at present. Recently, it has been shown that a drug called psilocybin, which belongs to a class of drugs known as psychedelics, may be effective in the treatment of some health conditions. There is reason to believe that psychedelic drugs could be particularly effective in the management of FND. These drugs have a unique mechanism of action that may enable the brain to re-learn how to process signals received from the body. In this study we will test if psilocybin (15mg or 1mg), combined with a course of specialised physiotherapy (8 sessions completed in an outpatient setting at the Austin Hospital in Heidelberg, VIC within a 2-week period), is effective in relieving FND motor and related symptoms.
Eligibility
Inclusion Criteria4
- i) Adult (18-70 years) patients with refractory motor FND
- ii) Symptoms must have been present for at least six months
- iii) Patients must have received physiotherapy for their current FND
- iv) Able to provide informed consent
Exclusion Criteria7
- i) Current or previous history of psychotic disorder or mania
- ii) Current drug or alcohol dependence
- iii) Recent, regular use of psychedelic agents
- iv) History of epileptic seizures
- v) Attempted suicide with high lethality means
- vi) Current pregnancy or breastfeeding
- vii) Other medical conditions rendering unsuitability for study
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Interventions
The intervention is psilocybin assisted physiotherapy comprising a single dose of oral Psilocybin (15mg or 1mg) and 8 sessions of specialised physiotherapy. Two physiotherapy sessions will be completed in the days prior to the participant taking psilocybin (randomised to receive 15mg or 1mg in a triple-blinded manner: participant, trial physio and mental health practitioner blinded). They will resume their six remaining physiotherapy sessions within 1-2 days following their psilocybin dosing session. Psilocybin will be provided in capsule form (5mg or 1mg capsules) and taken orally. Matching placebo capsules will be used to assist blinding. For example, 15mg will be administered via x3 5mg psilocybin capsules, whereas 1mg will be administered via x1 1mg capsule and two placebo capsules. Participants will be monitored by a mental health practitioner (MHP) for up to 5 hours following psilocybin administration. After dosing, participants will be encouraged to relax and the MHP will be available to provide support and discuss any experiences the participant may be having in an open and non-judgmental manner. Vital signs will be checked at regular intervals after dosing (30mins, 60mins, 3 hours and 5 hours post dosing) and any adverse events will be recorded. A physiotherapist trained in the Physio4FMD treatment protocol (https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(24)00135-2/fulltext) will deliver the physiotherapy treatment. Sessions will occur face-to-face at the Austin Hospital in Heidelberg, VIC in a one-to-one manner (one physio to one participant). Participants will be provided a study specific workbook adapted from the Physio4FMD intervention (https://doi.org/10.24376/rd.sgul.23967024) to facilitate the sessions. Exercises will be tailored to each individual and based around functional practice. An example may be encouraging the participant to adjust the distribution of weight in their feet when walking, or to walk backwards. This type of physiotherapy treatment focuses on observing quality and efficacy of movement rather than intensity, therefore, a measure of intensity is not included in the intervention. The first two sessions will take 90 minutes per session to complete, whereas the remaining six sessions will be 60 minutes each. Participants will be encouraged to complete 1-2 sessions of physiotherapy each day and complete all sessions within 2-weeks following psilocybin administration. To maintain the fidelity of the physiotherapy treatment provided to participants, we will use an approach based on the Physio4FMD protocol designed by Nielsen et al (2024). This comprises the following two components: 1. Fidelity at the level of physiotherapist. The physiotherapist providing the physiotherapy treatment will complete a checklist for each participant. This checklist will be based on the TIDIER checklist description. 2. Independent assessment of fidelity. A random sample of completed participant workbooks will be assessed. The workbook guides the intervention and is completed during the treatment session by both the participant and physiotherapist. It therefore provides a record of the content of sessions. The workbooks will be assessed against a predetermined set of criteria to determine the extent to which treatment followed the intervention protocol.
Locations(1)
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ACTRN12626000250336