Restoring Independence With Stimulation-Enhanced Treatment for People With Functional Neurological Disorder (RISE-FND)
12 de agosto de 2026 atualizado por: Cathy Stinear, University of Auckland, New Zealand
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
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
This clinical trial is for people who have difficulty walking because their movement is affected by Functional Neurological Disorder (FND).
The trial is testing a new treatment strategy that uses non-invasive brain stimulation to prepare the brain for specialist physical therapy.
Participants will be randomly assigned to one of two groups.
Both groups will complete three in-person sessions on three consecutive days.
Participants in the treatment group have non-invasive brain stimulation, followed by specialist physical therapy.
Participants in the comparison group have goal-setting and mental practice, followed by specialist physical therapy.
Participants complete follow-up assessments by video call at 1 week, 1 month and 3 months after treatment, to evaluate their walking and balance.
Participants are also asked to complete some simple online questionnaires at these follow-up time points.
All assessments of walking and balance are carried out by a researcher who is unaware of which group the participant has been assigned to.
Tipo de estudo
Intervencional
Inscrição (Estimado)
60
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Cathy Stinear
- Número de telefone: +64210770788
- E-mail: c.stinear@auckland.ac.nz
Estude backup de contato
- Nome: Winston Byblow
- Número de telefone: +640211444252
- E-mail: w.byblow@auckland.ac.nz
Locais de estudo
-
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Auckland
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Auckland, Auckland, Nova Zelândia, 1142
- Clinical Research Centre, Grafton Campus, University of Auckland
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Contato:
- Cathy Stinear
- Número de telefone: +64 21 077 0788
- E-mail: c.stinear@auckland.ac.nz
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Contato:
- Ben Scrivener
- E-mail: b.scrivener@auckland.ac.nz
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Investigador principal:
- Cathy Stinear, PhD
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Stimulation-Enhanced Physical Therapy
Participants complete baseline assessments up to 7 days prior to the first treatment day.
On the first treatment day participants meet with their treating team to review their current symptoms and discuss FND to ensure they understand the condition.
On the second treatment day the treating team delivers the experimental intervention.
The primary outcome measure is obtained at the end of this session by the blinded clinical assessor.
On the third treatment day the treating team discusses ongoing self-management with the participant.
|
The intervention uses Transcranial Magnetic Stimulation (TMS) to activate the motor pathways from the primary motor cortex to affected lower limb muscles.
This is followed by specialist physical therapy applying consensus recommendations for the treatment of movement symptoms due to FND.
Key elements include distraction, momentum, and exploratory movement.
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|
Comparador Ativo: Standard Physical Therapy
Participants complete baseline assessments up to 7 days prior to the first treatment day.
On the first treatment day participants meet with their treating team to review their current symptoms and discuss FND to ensure they understand the condition.
On the second treatment day the treating team delivers the active comparator intervention.
The primary outcome measure is obtained at the end of this session by the blinded clinical assessor.
On the third treatment day the treating team discusses ongoing self-management with the participant.
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The active comparator uses structured goal-setting and movement imagery to prepare for physical therapy.
This is followed by specialist physical therapy applying consensus recommendations for the treatment of movement symptoms due to FND.
Key elements include distraction, momentum, and progressive movement retraining.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Odds of achieving effective treatment defined as a Tinetti Performance-Oriented Mobility Assessment (POMA) score of at least 24 out of 28.
Prazo: From enrolment until the Tinetti POMA score is evaluated immediately upon completion of treatment on day zero.
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The Tinetti POMA is a reliable and valid assessment for use with a broad range of neurological conditions, with excellent interrater reliability.
It evaluates key symptom domains of gait, trunk stability, and postural balance.
The minimum and worst score is zero.
The maximum and best score is 28.
The odds ratio for achieving effective treatment will be calculated for the treatment group relative to the control group.
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From enrolment until the Tinetti POMA score is evaluated immediately upon completion of treatment on day zero.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Functional Movement Disorder Questionnaire (FMDQ)
Prazo: Baseline, 30 days and 90 days post-treatment.
|
The FMDQ is a summed severity and impact questionnaire in which participants rate the presence and severity of functional movement symptoms across multiple domains.
Each item is scored on a Likert type scale, and a total score (range 31-181) is calculated, with higher scores indicating greater functional symptom burden.
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Baseline, 30 days and 90 days post-treatment.
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EQ-5D-5L
Prazo: Baseline, 30 days post-treatment, and 90 days post-treatment.
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The EQ-5D-5L is a self-reported questionnaire of quality of life that is validated for general and neurological populations.
The EQ-5D-5L assesses five key dimensions of health and using a 5-point Likert scale.
An index score is derived from the combination of individual domain ratings using a country-specific value set which reflects societal preferences for different health states.
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Baseline, 30 days post-treatment, and 90 days post-treatment.
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Tinetti POMA score during follow-up
Prazo: 7 days, 30 days and 90 days post-treatment.
|
The Tinetti POMA score will be obtained via video call during the follow-up period.
It evaluates key symptom domains of gait, trunk stability, and postural balance.
The minimum and worst score is zero.
The maximum and best score is 28.
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7 days, 30 days and 90 days post-treatment.
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Walking independence
Prazo: Baseline, day -1 before treatment, day zero of treatment, and day 1 post-treatment, and at 7 days, 30 days and 90 days post-treatment.
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Walking independence will be evaluated with the Functional Ambulation Category (FAC), which is a valid and reliable measure of a person's level of independence in mobility and walking.
The lowest and worst score is zero, meaning fully dependent.
The highest and best score is 5, meaning fully independent walking.
Participants will be classified as independent if they have a FAC score of 4 or 5 out of 5. Participants will be classified as dependent if they have a FAC score of 0, 1, 2 or 3.
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Baseline, day -1 before treatment, day zero of treatment, and day 1 post-treatment, and at 7 days, 30 days and 90 days post-treatment.
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Simplified Functional Movement Disorders Rating Scale (S-FMDRS)
Prazo: Day -1 before treatment, day zero of treatment, and day 1 post-treatment.
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The S-FMDRS is a clinician-rated score of overall functional movement symptom severity.
The assessor will video the assessment to support their review and scoring accuracy.
A total score out of 54 is recorded with higher scores indicating greater symptom severity.
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Day -1 before treatment, day zero of treatment, and day 1 post-treatment.
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Lower limb strength
Prazo: Day -1 before treatment, day zero of treatment, and day 1 post-treatment.
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Total lower limb strength score will be calculated by summing the Medical Research Council grades for knee flexion, knee extension, ankle dorsiflexion, and ankle plantarflexion for each limb.
The summed bilateral score will be used for analysis of between-group effects.
The minimum and worst score is zero, the maximum and best score is 40.
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Day -1 before treatment, day zero of treatment, and day 1 post-treatment.
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Light touch sensation
Prazo: Day -1 before treatment and day 1 post-treatment.
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Lower limb sensation will be assessed using Semmes-Weinstein monofilaments.
With vision occluded, participants will be asked to indicate detection of progressively smaller filament sizes applied perpendicularly to the plantar surface of the great toe until the smallest reliably perceived filament is identified.
Lower filament scores indicate better light touch sensation.
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Day -1 before treatment and day 1 post-treatment.
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Patient Global Impression of Improvement
Prazo: Day zero after treatment and at 90 days post-treatment.
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The Patient Global Impression of Improvement (PGI-I) scale is a patient-reported measure used to evaluate participants' overall impression of change following treatment.
The lowest score is zero, meaning "very much worse", and the highest score is 7, meaning "very much improved".
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Day zero after treatment and at 90 days post-treatment.
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Upper limb performance
Prazo: Day -1 before treatment, day zero of treatment, and day 1 post-treatment.
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The Box and Blocks Test is a timed test of upper limb motor performance.
It will be used to evaluate the more-affected upper limb of participants who report upper limb functional symptoms.
More blocks moved in 60 seconds indicates better upper limb motor performance.
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Day -1 before treatment, day zero of treatment, and day 1 post-treatment.
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Brief Illness Perception Questionnaire (B-IPQ)
Prazo: Baseline and 90 days post-treatment.
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The Brief Illness Perception Questionnaire (B-IPQ) is a patient-reported measure of illness perception.
Each of eight items is scored individually on a 0 to 10 scale.
Higher scores indicate a more threatening or negative perception.
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Baseline and 90 days post-treatment.
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Pain Interference
Prazo: Baseline, and 7 days, 30 days and 90 days post-treatment.
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The PROMIS Pain Interference Short Form is a patient-reported measure of how much pain has interfered with daily activities over the past 7 days.
The scale has 8 items, each rated on a 5-point scale with the lowest score of zero meaning "not at all", and the highest score of 5 meaning "very much".
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Baseline, and 7 days, 30 days and 90 days post-treatment.
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Fatigue Interference
Prazo: Baseline, and 7 days, 30 days and 90 days post-treatment.
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The PROMIS Fatigue Interference Short Form is a patient-reported measure of how much pain has interfered with daily activities over the past 7 days.
The scale has 8 items, each rated on a 5-point scale with the lowest score of zero meaning "not at all", and the highest score of 5 meaning "very much".
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Baseline, and 7 days, 30 days and 90 days post-treatment.
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Self-rated Function
Prazo: Baseline and 90 days post-treatment.
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The Patient-Specific Functional Scale is an evaluation of participant-identified functional limitations.
Participants nominate up to 3 activities they are currently unable to perform, or have difficulty performing, due to their symptoms.
Each activity is rated on an 11-point scale from zero meaning 'unable to perform' to 10 meaning 'able to perform at prior level'.
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Baseline and 90 days post-treatment.
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Treatment readiness
Prazo: Day -1 before treatment and day zero of treatment.
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Treating clinicians will independently rate participant readiness to progress using a simple 4-point Likert scale, where zero means "definitely not ready" and 4 means "definitely ready".
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Day -1 before treatment and day zero of treatment.
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Employment status
Prazo: Baseline and 90-days post-treatment.
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Participation in paid work or employment will be evaluated by asking participants to provide the average number of hours worked per week over the past 6 months.
They will be asked to rate their perceived ability to work on a Likert scale, with a minimum score of zero meaning no ability to work, and a maximum score of 10 meaning able to fully participate in work.
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Baseline and 90-days post-treatment.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Cathy Stinear, University of Auckland, New Zealand
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de novembro de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2029
Conclusão do estudo (Estimado)
1 de abril de 2030
Datas de inscrição no estudo
Enviado pela primeira vez
7 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de agosto de 2026
Primeira postagem (Real)
18 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RISE-FND
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
De-identified IPD that underlie the study's published results will be shared.
Prazo de Compartilhamento de IPD
Beginning 1 year after publication of results and ending 3 years after publication of results.
Critérios de acesso de compartilhamento IPD
Researchers who wish to access the data and supporting information will be invited to contact the investigators directly and to submit a proposal for their planned use of the data that includes an independently reviewed statistical analysis plan.
If the proposal is methodologically sound and approved by the investigators then a data sharing agreement will need to be in place prior to the data being released.
Tipo de informação de suporte de compartilhamento de IPD
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .