RecruitingACTRN12625000492459

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.


Sponsor

Waipapa Taumata Rau, University of Auckland

Enrollment

30 participants

Start Date

Aug 13, 2025

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Functional Neurological Disorder (FND) is a condition where the brain and nervous system are not damaged but are not working properly — causing real, disabling symptoms like weakness, tremor, or difficulty walking. People with FND affecting their ability to walk face significant challenges, and current treatments are often limited. This study is testing a new combination approach: a specialised physiotherapy session enhanced by transcranial magnetic stimulation (TMS), a non-invasive technique that activates the brain regions responsible for movement. Participants receive a single, tailored physiotherapy session that incorporates TMS to prime the brain for movement. Walking ability is assessed immediately before and after the session, and again at 1, 4, and 12 weeks. Participants are also interviewed about their experience and how the treatment affected their wellbeing. You may be eligible if you are 18 or older, have a clinically established diagnosis of functional neurological disorder with lower limb weakness, have difficulty walking without a walking aid most days, and have no contraindications to TMS (such as a pacemaker or history of seizures). This pilot study will inform the design of a larger trial for this underserved and often misunderstood condition.

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

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)

New Zealand

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