Restoring Independence With Stimulation-Enhanced Treatment for People With Functional Neurological Disorder (RISE-FND)

August 12, 2026 updated by: 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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • New Zealand
    • Auckland
      • Auckland, Auckland, New Zealand, 1142
        • Clinical Research Centre, Grafton Campus, University of Auckland
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cathy Stinear, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Combination product: Stimulation-Enhanced Physical Therapy
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 Comparator: 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.
Other: Active Comparator
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From enrolment until the Tinetti POMA score is evaluated immediately upon completion of treatment on day zero.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Movement Disorder Questionnaire (FMDQ)
Time Frame: 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.
Baseline, 30 days and 90 days post-treatment.
EQ-5D-5L
Time Frame: Baseline, 30 days post-treatment, and 90 days post-treatment.
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.
Baseline, 30 days post-treatment, and 90 days post-treatment.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tinetti POMA score during follow-up
Time Frame: 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.
7 days, 30 days and 90 days post-treatment.
Walking independence
Time Frame: 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.
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.
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.
Simplified Functional Movement Disorders Rating Scale (S-FMDRS)
Time Frame: Day -1 before treatment, day zero of treatment, and day 1 post-treatment.
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.
Day -1 before treatment, day zero of treatment, and day 1 post-treatment.
Lower limb strength
Time Frame: Day -1 before treatment, day zero of treatment, and day 1 post-treatment.
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.
Day -1 before treatment, day zero of treatment, and day 1 post-treatment.
Light touch sensation
Time Frame: Day -1 before treatment and day 1 post-treatment.
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.
Day -1 before treatment and day 1 post-treatment.
Patient Global Impression of Improvement
Time Frame: Day zero after treatment and at 90 days post-treatment.
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".
Day zero after treatment and at 90 days post-treatment.
Upper limb performance
Time Frame: Day -1 before treatment, day zero of treatment, and day 1 post-treatment.
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.
Day -1 before treatment, day zero of treatment, and day 1 post-treatment.
Brief Illness Perception Questionnaire (B-IPQ)
Time Frame: Baseline and 90 days post-treatment.
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.
Baseline and 90 days post-treatment.
Pain Interference
Time Frame: Baseline, and 7 days, 30 days and 90 days post-treatment.
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".
Baseline, and 7 days, 30 days and 90 days post-treatment.
Fatigue Interference
Time Frame: Baseline, and 7 days, 30 days and 90 days post-treatment.
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".
Baseline, and 7 days, 30 days and 90 days post-treatment.
Self-rated Function
Time Frame: Baseline and 90 days post-treatment.
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'.
Baseline and 90 days post-treatment.
Treatment readiness
Time Frame: Day -1 before treatment and day zero of treatment.
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".
Day -1 before treatment and day zero of treatment.
Employment status
Time Frame: Baseline and 90-days post-treatment.
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.
Baseline and 90-days post-treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Auckland, New Zealand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cathy Stinear, University of Auckland, New Zealand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RISE-FND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified IPD that underlie the study's published results will be shared.

IPD Sharing Time Frame

Beginning 1 year after publication of results and ending 3 years after publication of results.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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