Restoring Independence With Stimulation-Enhanced Treatment for People With Functional Neurological Disorder

NCT07769970 | Not Yet Recruiting DMC

• 1 other identifier: RISE-FND
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Functional Neurological Disorder; Conversion Disorder

Keywords

Functional Neurological Disorder; Conversion Disorder; Walking; Weakness; Paralysis

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline, 30 days and 90 days post-treatment.

• EQ-5D-5L

  Baseline, 30 days post-treatment, and 90 days post-treatment.

Other Outcomes (13)

• Tinetti POMA score during follow-up

  7 days, 30 days and 90 days post-treatment.

• Walking independence

  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)

  Day -1 before treatment, day zero of treatment, and day 1 post-treatment.

Study Arms (2)

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.

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.

Other: Active Comparator

Interventions

Stimulation-Enhanced Physical Therapy COMBINATION_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.

Stimulation-Enhanced Physical Therapy

Active Comparator OTHER

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.

Standard Physical Therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• days or more since first onset of functional motor symptoms
• Tinetti POMA score \< 21/28

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Auckland, New Zealand: lead

Study Sites (1)

Clinical Research Centre, Grafton Campus, University of Auckland

Auckland, Auckland, 1142, New Zealand

Location

MeSH Terms

Conditions

Conversion Disorder; Asthenia; Paralysis

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases

Study Officials

• Cathy Stinear

  University of Auckland, New Zealand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathy Stinear

CONTACT

+64210770788; c.stinear@auckland.ac.nz

Winston Byblow

CONTACT

+640211444252; w.byblow@auckland.ac.nz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 18, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): April 1, 2030
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Beginning 1 year after publication of results and ending 3 years after publication of results.
• 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.

Locations

NZ (1)