Restoring Independence With Stimulation-Enhanced Treatment for People With Functional Neurological Disorder (RISE-FND)
12. srpna 2026 aktualizováno: 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
Přehled studie
Postavení
Zatím nenabíráme
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
60
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Cathy Stinear
- Telefonní číslo: +64210770788
- E-mail: c.stinear@auckland.ac.nz
Studijní záloha kontaktů
- Jméno: Winston Byblow
- Telefonní číslo: +640211444252
- E-mail: w.byblow@auckland.ac.nz
Studijní místa
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Auckland
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Auckland, Auckland, Nový Zéland, 1142
- Clinical Research Centre, Grafton Campus, University of Auckland
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Kontakt:
- Cathy Stinear
- Telefonní číslo: +64 21 077 0788
- E-mail: c.stinear@auckland.ac.nz
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Kontakt:
- Ben Scrivener
- E-mail: b.scrivener@auckland.ac.nz
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Vrchní vyšetřovatel:
- Cathy Stinear, PhD
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
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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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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.
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Functional Movement Disorder Questionnaire (FMDQ)
Časové okno: Baseline, 30 days and 90 days post-treatment.
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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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Tinetti POMA score during follow-up
Časové okno: 7 days, 30 days and 90 days post-treatment.
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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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Cathy Stinear, University of Auckland, New Zealand
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. listopadu 2026
Primární dokončení (Odhadovaný)
1. prosince 2029
Dokončení studie (Odhadovaný)
1. dubna 2030
Termíny zápisu do studia
První předloženo
7. srpna 2026
První předloženo, které splnilo kritéria kontroly kvality
12. srpna 2026
První zveřejněno (Aktuální)
18. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
18. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
12. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- RISE-FND
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
De-identified IPD that underlie the study's published results will be shared.
Časový rámec sdílení IPD
Beginning 1 year after publication of results and ending 3 years after publication of results.
Kritéria přístupu pro sdílení 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.
Typ podpůrných informací pro sdílení IPD
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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