Clinical TrialNeurological InjuryPsilocybinPsilocybinNot yet recruiting

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.

Target Enrollment
24 participants
Study Type
Phase I/II interventional
Design
Randomized, single Blind

Detailed Description

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.

Study Protocol

Preparation

3 sessions
60 min each

Dosing

1 sessions
390 min each

Integration

6 sessions
60 min each

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Low dose 15 mg

experimental

Single oral 15 mg psilocybin dose plus physiotherapy (preparation and follow-up sessions).

Interventions

  • Psilocybin15 mg
    via Oral• single dose• 1 doses total

    Administered as 5 mg capsules (3 capsules); taken with water under supervision; paired with physiotherapy.

Standard dose 25 mg

experimental

Single oral 25 mg psilocybin dose plus physiotherapy (preparation and follow-up sessions).

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Administered as 5 mg capsules (5 capsules); taken with water under supervision; paired with physiotherapy.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Adults aged 18 to 65 years with a diagnosis of refractory motor FND supported by relevant neurological investigations and independent assessment by a psychiatrist and neurologist.
  • Refractory motor FND is defined as upper or lower limb motor weakness, gait disorder or movement disorder (e.g. tremor) of at least 6 months' duration.
  • Participants must have previously received physiotherapy and psychiatric management.
  • Participants must demonstrate understanding of their diagnosis and capacity to provide informed consent.

Exclusion Criteria

  • Medical exclusion criteria:
  • Cardiovascular conditions: poorly-controlled hypertension, angina, ischaemic heart disease, a clinically significant ECG abnormality (e.g. atrial fibrillation), transient ischaemic attack (TIA), stroke, peripheral or pulmonary vascular disease.
  • Diagnosis of epilepsy or previous seizures.
  • Diagnosis of dementia.
  • History of chronic kidney disease or chronic liver disease.
  • Known conditions putting the participant at risk for hypercalcaemia, Cushing's syndrome, hypoglycaemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH), or carcinoid syndrome.
  • Insulin-dependent diabetes; participants on oral hypoglycaemic agents excluded only if they also have a history of hypoglycaemia.
  • Females who are pregnant, nursing or trying to conceive.
  • Use of medications contraindicated with psilocybin or that are inappropriate to cease for the necessary time period before/after dosing.
  • Enrollment in another clinical trial involving an investigational product.
  • Psychological exclusion criteria:
  • Current or previous diagnosis of any psychotic disorder (including schizophrenia, schizoaffective disorder, schizotypal personality disorder, delusional disorder, substance/medication-induced psychotic disorder, or psychotic disorder due to another medical condition).
  • Current or previous diagnosis of Bipolar I or II disorder.
  • First-degree relative with diagnosed schizophrenia, psychotic disorder, or Bipolar I or II disorder.
  • History of attempted suicide or mania.
  • Current or previous diagnosis of substance use disorder (excluding caffeine and nicotine).
  • Previous regular use, or current use of psychedelic agents.
  • Current diagnosis of other psychiatric conditions judged to be incompatible with safe exposure to psilocybin.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment24 participants
  • Timeline
    Start: 2023-09-04
    End: 2024-12-31
  • Compounds
    PsilocybinPsilocybin
  • Topic
    Neurological Injury

Locations

Unknown facility — Australia

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