Study of Transcranial Magnetic Stimulation Enhanced Physiotherapy for people with Functional Movement Disorder.
A phase 2a, single arm study of Transcranial Magnetic Stimulation Enhanced Physiotherapy to Restore Movement Agency and Walking Independence in people with Functional Movement Disorder.
Waipapa Taumata Rau, University of Auckland
30 participants
Aug 13, 2025
Interventional
Conditions
Summary
This study is for people with functional weakness affecting their ability to walk. People who take part will be assessed, then complete a one-off specialised physiotherapy session that includes activating the brain areas responsible for walking with a non-invasive stimulation technique. Their walking will be assessed again immediately afterwards, and again 1, 4 and 12 weeks later. We expect that most people will experience a meaningful improvement in their walking ability. We will also interview participants about their experiences of the treatment and its effects on their wellbeing. This study will help us to see how effective this approach is so we can design a larger clinical trial.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
A single session of transcranial magnetic stimulation (TMS) and distal limb pressure feedback will be used immediately prior to a specialist physiotherapy session. Participants will receive up to 25 single-pulse stimulations of TMS per affected hemisphere, delivered by a researcher. Stimulations are delivered in blocks of 3 or 4, at 100% maximum stimulator output (MSO) over each affected hemispheres primary motor cortex, while the participant attempts voluntary movement of their affected lower limb. Distal limb pressure from a researcher's hands will be used concurrently with stimulations. Contemporary neuroscientific explanations of Functional Movement Disorder (FMD) and educational components will be delivered throughout. Explanations will include using the ‘software-hardware’ analogy and a conversation about using TMS as a way of boosting the brain signal to their affected limb(s). Participants will be shown their TMS traces, identifying motor evoked potentials (MEPs). A researcher will explain basic features of the TMS traces and relate these to the participant's individual presentation. TMS and discussions are expected to take 30 minutes. Immediately following TMS, participants will start a single individualised physiotherapy session, delivered face-to-face by a neurological physiotherapist with at least 10 years experience. Physiotherapy will use established FMD treatment principles and will be delivered in a gym or clinic. FMD physiotherapy treatment-based principles include: building trust before challenging the patient, projecting confidence, creating an expectation for improvement, limiting ‘hands-on’ treatment and focusing attention away from impairment and towards function, by use of distraction. Examples include conversational distraction, or throwing and catching a rugby ball, while standing. The physiotherapy session may last for a maximum of 3 hours total, and will include rest periods as needed. Family or supporters will be encouraged to join in the treatment session and will be included in educational moments. Participants will be encouraged to use their individualised distraction strategies after the session. Physiotherapy sessions may also include discussion of key topics: beliefs about symptoms and diagnosis, fatigue, distraction, self-management principles, and how to manage an unexpected dramatic recovery. To meet the intervention protocol, participants must have: a minimum of 10 stimulations above 70% MSO, with pressure feedback, per side affected; and a minimum of 20 minutes of time spent active during physiotherapy interventions.
Locations(1)
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ACTRN12625000492459