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

N/ANot Yet RecruitingNCT07769970

University of Auckland, New Zealand60 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Interventions

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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: From enrolment until the Tinetti POMA score is evaluated immediately upon completion of treatment on day zero.

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline, 30 days post-treatment, and 90 days post-treatment.