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.
Trial Details
Functional Neurological Disorder is a common neuropsychiatric condition which is often chronic and results in debilitating symptoms such as weakness or sensory impairment. The symptoms of Functional Neurological Disorder are not caused by structural abnormalities within the brain or nervous system, and unfortunately no effective therapy currently exists. It is thought that drugs belonging to a class known as psychedelics, when administered in conjunction with a physiotherapy regime, may be particularly effective in the treatment of Functional Neurological Disorder but this therapeutic intervention has not previously been investigated in a clinical trial. Therefore, this study will assess the safety and obtain preliminary evidence for efficacy of psilocybin-assisted physiotherapy for patients with refractory motor Functional Neurological Disorder.NCT Number ACTRN12621000578808