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

2026년 8월 12일 업데이트: 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

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 뉴질랜드
    • Auckland
      • Auckland, Auckland, 뉴질랜드, 1142
        • Clinical Research Centre, Grafton Campus, University of Auckland
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Cathy Stinear, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
조합 제품: 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.
활성 비교기: 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.
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Odds of achieving effective treatment defined as a Tinetti Performance-Oriented Mobility Assessment (POMA) score of at least 24 out of 28.
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Functional Movement Disorder Questionnaire (FMDQ)
기간: 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
기간: 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.

기타 결과 측정

결과 측정
측정값 설명
기간
Tinetti POMA score during follow-up
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Auckland, New Zealand

수사관

  • 수석 연구원: Cathy Stinear, University of Auckland, New Zealand

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 11월 1일

기본 완료 (추정된)

2029년 12월 1일

연구 완료 (추정된)

2030년 4월 1일

연구 등록 날짜

최초 제출

2026년 8월 7일

QC 기준을 충족하는 최초 제출

2026년 8월 12일

처음 게시됨 (실제)

2026년 8월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 12일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RISE-FND

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

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

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다