Functional Neurological DisorderRISE-FNDNCT07769970
Restoring Independence With Stimulation-Enhanced Treatment for People With Functional Neurological Disorder
A study testing Stimulation-Enhanced Physical Therapy and Active Comparator in people with Functional Neurological Disorder and Conversion Disorder, run by University of Auckland, New Zealand at 1 site in New Zealand.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Functional Neurological Disorder, Conversion Disorder
- What is being tested?
- Stimulation-Enhanced Physical Therapy and Active Comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNew Zealand
- Study dates
- Nov 2026to Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand1 site
Clinical Research Centre, Grafton Campus, University of Auckland
Auckland, Auckland, 1142
Cathy Stinear, +64 21 077 0788, c.stinear@auckland.ac.nz
Ben Scrivener, b.scrivener@auckland.ac.nz
About this study
Official title: 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
Read the detailed description
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.
- Being tested
- Stimulation-Enhanced Physical Therapy, Active Comparator
- Keywords
- Functional Neurological Disorder, Conversion Disorder, Walking, Weakness, Paralysis
- Medical subject headings
- Conversion Disorder, Asthenia, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation-Enhanced Physical TherapyCombination product
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.
Active ComparatorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation-Enhanced Physical Therapy | Experimental | 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. Receives: Combination Product: Stimulation-Enhanced Physical Therapy |
| Standard Physical Therapy | Active comparator | 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. Receives: Other: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds of achieving effective treatment defined as a Tinetti Performance-Oriented Mobility Assessment (POMA) score of at least 24 out of 28.
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.
Measured: From enrolment until the Tinetti POMA score is evaluated immediately upon completion of treatment on day zero.
Secondary outcomes (2)
Functional Movement Disorder Questionnaire (FMDQ)
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.
Measured: Baseline, 30 days and 90 days post-treatment.
EQ-5D-5L
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.
Measured: Baseline, 30 days post-treatment, and 90 days post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Neurological DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathy Stinear, University of Auckland, New Zealand
- Investigators
- Cathy Stinear, Principal investigator, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769970
- Sponsor's protocol ID
- RISE-FND
- Acronym
- RISE-FND
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD that underlie the study's published results will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07769970
- Acronym / sponsor ID
- RISE-FND / RISE-FND
- Keywords
- Functional Neurological Disorder, Conversion Disorder, Walking, Weakness, Paralysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation-Enhanced Physical Therapy | Experimental | Combination Product: Stimulation-Enhanced Physical TherapyParticipants 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. |
| Standard Physical Therapy | Active comparator | Other: Active ComparatorParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimulation-Enhanced Physical TherapyThe 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. | Combination product | Stimulation-Enhanced Physical Therapy |
| Active ComparatorThe 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. | Other | Standard Physical Therapy |
Primary outcome
Odds of achieving effective treatment defined as a Tinetti Performance-Oriented Mobility Assessment (POMA) score of at least 24 out of 28.
Time frame: From enrolment until the Tinetti POMA score is evaluated immediately upon completion of treatment on day zero.
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.
2 secondary outcomes
Functional Movement Disorder Questionnaire (FMDQ)
Time frame: Baseline, 30 days and 90 days post-treatment.
EQ-5D-5L
Time frame: Baseline, 30 days post-treatment, and 90 days post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified IPD that underlie the study's published results will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cathy Stinear principal investigator
University of Auckland, New Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation-Enhanced Physical Therapy and Active Comparator in people with Functional Neurological Disorder and Conversion Disorder, run by University of Auckland, New Zealand at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cathy Stinear (+64210770788, c.stinear@auckland.ac.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Odds of achieving effective treatment defined as a Tinetti Performance-Oriented Mobility Assessment (POMA) score of at least 24 out of 28. (time frame: From enrolment until the Tinetti POMA score is evaluated immediately upon completion of treatment on day zero.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.