Restoring Independence With Stimulation-Enhanced Treatment for People With Functional Neurological Disorder

A Phase 3, Single-site, Assessor-blinded, Randomised Controlled Trial of Transcranial Magnetic Stimulation-Enhanced Treatment to Restore Movement Agency and Walking Independence in People With Functional Neurological Disorder

The goal of this clinical trial is to test a new treatment for adults with walking problems due to Functional Neurological Disorder (FND).

The main question the trial aims to answer is:

- Is stimulation-enhanced physical therapy an effective treatment for walking problems due to FND?

Researchers will compare the stimulation-enhanced physical therapy to gold-standard physical therapy.

Participants will:

• Complete three in-person sessions on three consecutive days
• Complete follow-up assessments by video call at 7 days, 30 days and 90 days after treatment

Inclusion Criteria:

• Clinically established diagnosis of FND or an equivalent term
• Investigations are accepted as complete by the patient and treating physician
• Walking difficulty that prevents crossing the road unaided at a traffic light pedestrian crossing
• Lower limb functional weakness
• 30 days or more since first onset of functional motor symptoms
• Tinetti POMA score < 21/28

Exclusion Criteria:

• Age < 21 years
• Living with a parent or guardian who provides primary emotional support and assistance with most daily tasks
• Medical instability precluding safe participation in physical therapy
• Cognitive or communication impairment precluding informed consent or the ability to effectively engage in education aspects of the trial with family support
• Untreated and severe psychiatric illness affecting the ability to safely participate
• Co-existing non-FND neurological or musculoskeletal impairments restricting walking independence
• A primary diagnosis of chronic pain or chronic fatigue syndrome
• Pain significantly limiting standing or walking
• Prior treatment for FND that included Transcranial Magnetic Stimulation (TMS)
• Contraindicated to TMS as determined using a standard safety screening checklist