Efficacy and tolerability of psilocybin-assisted physiotherapy on motor symptoms in refractory Functional Neurological Disorder
Randomised parallel Phase I/II pilot (n=24) comparing a single 15 mg versus 25 mg oral psilocybin dose paired with physiotherapy for refractory motor FND to assess safety and preliminary efficacy.
Details
Randomised parallel Phase I/II single-centre pilot enrolling 24 participants with refractory motor functional neurological disorder; participants receive a single supervised oral psilocybin dose (15 mg or 25 mg) combined with physiotherapy.
Procedures include a pre-dosing mental health preparation session, two physiotherapy preparation sessions, in-session monitoring with vital signs for approximately 5 hours post-dose, and 3-6 follow-up physiotherapy sessions of ~60 minutes each; outcomes include clinician- and participant-rated motor symptom severity and resting-state/task fMRI.
Safety assessed via adverse events and vital signs; treatment fidelity monitored via checklists, participant reports and independent workbook review.