Efficacy and tolerability of psilocybin-assisted physiotherapy on motor symptoms in refractory Functional Neurological Disorder

This pilot and feasibility trial (n=24) aims to assess the safety and preliminary efficacy of psilocybin-assisted (5-25mg) physiotherapy for refractory motor Functional Neurological Disorder (FND).

Participants will receive either a single dose of oral psilocybin (5mg, 10mg, or 15mg) or a single 25mg dose, followed by specialised physiotherapy treatments. The trial will be conducted at either the Austin Hospital or Heidelberg Repatriation Hospital in Melbourne, Australia.

Adults aged 18 to 65 years with refractory motor FND will be recruited, totaling 24 participants. After eligibility confirmation, participants will undergo a preparation session before the psilocybin dosing session. Psilocybin will be administered under supervision, followed by vital sign monitoring. Those in the low-dose arm will complete movement tasks during the session, while the standard dose arm will not.

Following psilocybin administration, participants will undergo 5 to 8 sessions of specialised physiotherapy treatments designed to alleviate motor symptoms. Treatment fidelity will be monitored through various methods. Outcome measures include participant-reported clinical impressions, motor disability assessments, clinician-rated severity of symptoms, and participant-reported depression and anxiety symptoms, among others. Safety will be assessed through adverse event monitoring.

The trial aims to provide insights into the safety and efficacy of psilocybin-assisted physiotherapy for refractory motor FND. The study is conducted at the Austin Hospital or Heidelberg Repatriation Hospital in Melbourne, Australia, and is funded by Austin Health, the Melbourne School of Psychological Sciences at the University of Melbourne, and the Usona Institute. The principal investigator is Prof Richard Kanaan.

Topic Neurocognitive Disorders
Compound Psilocybin
Country Australia
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