Investigating the Neurophysiology of the Motor System and the Feasibility of Vagus Nerve Stimulation in Functional Neurological Disorder (FND) (TMS-VNS)
2026년 7월 16일 업데이트: University of Fribourg
Investigating the Neurophysiology of the Motor System and the Feasibility of Vagus Nerve Stimulation in Functional Neurological Disorder (FND): a Randomized, Sham-controlled Study
This clinical study will test if adding a non-invasive stimulation of the vagus nerve through the ear during physiotherapy brings an improvement to FND (Functional Neurological Disorder) patients with motor symptoms.
First, the investigators will test the normal functioning of the motor regions of the brain in FND patients and in healthy volunteers for comparison, using a painless method called TMS (Transcranial Magnetic Stimulation). Then, the investigators will further test how brain regions communicate with each other in FND patients, using fMRI (functional Magnetic Resonance Imaging, also painless). Additionally, the investigators will ask both FND patients and healthy volunteers to answer questions about their health and wellbeing, and will assess the exact symptoms of FND patients. The FND patients will then be assigned to two groups randomly, and neither they nor the researchers will know in which group they are. Both groups will do 5 sessions of their usual physiotherapy - one group with a real stimulation of the vagus nerve, and the other group with a fake stimulation. This is important to obtain reliable results. At the end, both groups of patients will be tested again to see if the way brain regions communicate with each other has changed. They will also answer again questions about their health and wellbeing, and their symptoms will be assessed again, to see if any changes happen. The results of the two groups of patients will be compared to isolate the effects of vagus nerve stimulation from the effects of physiotherapy alone.
연구 개요
상태
아직 모집하지 않음
상세 설명
The main goal of this project is to better understand the neurophysiology of the motor system and the role of attention in Functional Neurological Disorder (FND) and to explore the physiological effects of a novel non-invasive treatment option for this disorder.
To this end, several methods will be employed: non-invasive brain stimulation (using Transcranial Magnetic Stimulation, TMS), neuroimaging (fMRI), transdermal auricular vagus nerve stimulation (taVNS), clinical assessments and questionnaires.
The study consists of 2 experiments, each with specific objectives.
Primary objective:
The primary objective of this study is to assess the effects of taVNS, as an adjunctive intervention to standard physical therapy, on the quality of life in FND patients.
Secondary objectives:
Experiment 1
- Assess baseline neurophysiological differences of the motor system at rest and under different attentional demands, between FND patients and healthy participants.
- Compare the motor behaviour of the upper limb (index finger) under different attentional demands, in FND patients and healthy participants.
- Explore the role of symptom severity, mood, physical health, and interoception (the perception of bodily signals), assessed by questionnaires, in the modulation of motor system neurophysiology in FND patients and healthy participants.
- Explore the relationship between neurophysiological (point 1) and behavioral (point 2) outcomes, and the outcomes of clinical and psychological scores measured (point 3).
Experiment 2
- Assess the feasibility of the taVNS intervention as an adjunctive treatment in FND.
- Determine whether adding taVNS to standard physical therapy improves clinical outcomes (motor symptoms) in FND patients, assessed by clinical scores (CGI, sFMDRS).
- Explore changes in self-reported measures of mood, stress, physical health and interoception (the perception of bodily signals), assessed by questionnaires, after taVNS in FND patients.
- Explore changes in upper limb strength, measured by a grip strength test with hand-held dynamometer under different starting conditions (pressing freely and pressing after a cue), before, during and after taVNS in FND.
- Assess the effect of taVNS on heart rate and heart rate variability (HRV) in FND patients.
- Analyse the modulation of brain network connectivity via fMRI at rest and during a behavioural task (emotion-motion task), before and after taVNS in FND patients.
- Explore the relationship between neuroimaging (point 6), behavioral (point 2) outcomes, and the outcomes of clinical and psychological scores measured (point 3).
An additional outcome will explore the relationship between the outcomes of Experiment 1 and Experiment 2 to assess the prognostic potential of the outcomes of Experiment 1.
연구 유형
중재적
등록 (추정된)
68
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Michael Mouthon, PhD
- 전화번호: +41 26 300 85 39
- 이메일: michael.mouthon@unifr.ch
연구 연락처 백업
- 이름: Selma Aybek, Professor
- 전화번호: +41 26 306 38 02
- 이메일: selma.aybek@unifr.ch
연구 장소
-
-
Canton of Fribourg
-
Fribourg, Canton of Fribourg, 스위스, 1700
- University of Fribourg
-
연락하다:
- Michael Mouthon, PhD
- 전화번호: +41 26 300 85 39
- 이메일: michael.mouthon@unifr.ch
-
부수사관:
- Michael Mouthon, PhD
-
연락하다:
- Selma Aybek, Professor
- 전화번호: +41 26 306 38 02
- 이메일: selma.aybek@unifr.ch
-
부수사관:
- Cristina Concetti, PhD
-
부수사관:
- Julia Paratte, Master
-
부수사관:
- Janne Magnin, Bachelor
-
부수사관:
- Sarah Botman, Bachelor
-
-
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
예
설명
Inclusion Criteria for FND patients:
- Over 18 years of age.
- Capable of judgement.
- Willing to participate in the study (by signing the informed consent form).
- FND diagnosis by a certified neurologist or psychiatrist.
- Motor FND symptoms in the upper limb in the form of tremor or weakness.
- Participating in physiotherapy for FND.
Exclusion Criteria for FND patients:
- Severe neuropsychiatric comorbidities.
- Pregnancy or breastfeeding.
- Prior knowledge on the effects of attention on the motor system.
- Prior history of epilepsy or epileptic seizures in the person and their family.
- Severe claustrophobia.
- Implanted medical devices.
- Ear anatomy incompatible with the taVNS device (e.g. cauliflower ear).
- Previous use of taVNS.
- Substance abuse.
- Simultaneous participation in another investigation involving an investigational drug or a MD.
- Enrolment of the PI and their dependent persons.
Inclusion Criteria for healthy volunteers:
- Over 18 years of age.
- Capable of judgement.
- Willing to participate in the study (by signing the informed consent form).
Exclusion Criteria for healthy volunteers:
- Neurological or neuropsychiatric or movement disorders.
- Pregnancy or breastfeeding.
- Prior knowledge on the effects of attention on the motor system.
- Prior history of epilepsy or epileptic seizures in the person and their family.
- Substance abuse.
- Simultaneous participation in another investigation involving an investigational drug or a MD.
- Enrolment of the PI and their dependent persons.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Patient VNS stimulation intervention
FND patients received a 30 minutes VNS stimulation for 5 sessions during their usual physiotherapy course treatment.
|
taVNS sends gentle electric stimuli to the vagus nerve branch located in the outer ear, which are transmitted to the nucleus of the solitary tract in the brainstem, and from there to the rest of the brain.
The electrode site is the cymba conchae in in the outer ear.
VNS thus acts to enhance the activity of the parasympathetic nervous system.
다른 이름들:
|
|
가짜 비교기: Patient VNS sham intervention
FND patients received a 30 minutes VNS sham for 5 sessions during their usual physiotherapy course treatment.
|
taVNS sends gentle electric stimuli for several minutes, during which time the patient will feel a tickling sensation.
Then, for the rest of the session, the hidden device will be switched off (there will be no stimulation).
다른 이름들:
|
|
간섭 없음: Heathy control without intervention
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Self-reported quality of life
기간: For each intervention session at weeks 3, 4, 5, 6, 7
|
The change in self-reported quality of life, measured through intervention sessions with the Euro Quality of Life questionnaire (EQ-5D-5L), compared between the active stimulation group and the sham stimulation group.
This questionnaire includes 5 subscales (1-best, 5-worstest) about mobility, self-care, usual activities, pain/discomfort, anxiety/depression.
In addition it includes a continue scale evaluation (0-worst to 100-best) about the patient evaluation on his health.
|
For each intervention session at weeks 3, 4, 5, 6, 7
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Neurophysiology investigation of the pathology by comparing Motor-Evoked Potential between FND patients and healthy participant
기간: At TMS session, week 2 for patients and week 0 for heathy controls
|
The study will examine cortical inhibition as measured by motor-evoked potentials (MEPs) during a short-interval intracortical inhibition (SICI) transcranial magnetic stimulation (TMS) protocol (single-pulse and paired-pulse).
The investigators will examine how the outcome differs under different attentional demands in patients with functional neurological disorder (FND) and healthy participants.
|
At TMS session, week 2 for patients and week 0 for heathy controls
|
|
Neurophysiology investigation of the pathology by comparing resting motor threshold between FND patients and healthy participant
기간: At TMS session, week 2 for patients and week 0 for heathy controls
|
The study will examine the resting motor threshold (in millivolts), which is the level of stimulation required to trigger motor-evoked potentials using a single-pulse transcranial magnetic stimulation (TMS) technique.
The investigators will examine how this outcome differs between patients with functional neurological disorder (FND) and healthy participants.
|
At TMS session, week 2 for patients and week 0 for heathy controls
|
|
Comparison of motor performance between patients and healthy controls
기간: At TMS session, week 2 for patients and week 0 for heathy controls
|
The differences in motor performance between FND patients and healthy controls were measured by the accuracy with which they maintained an isometric contraction during index finger abduction at 10% of maximum force.
|
At TMS session, week 2 for patients and week 0 for heathy controls
|
|
Satisfaction rating of patients on the intervention
기간: At the end of the last intervention session at week 7
|
Patients will be asked to rate their satisfaction after the intervention on a scale from 1 to 10.
|
At the end of the last intervention session at week 7
|
|
Changes in upper limb strength, measured by a grip strength test under different starting conditions, before, during and after taVNS intervention.
기간: weeks 2, 3, 4, 5, 6, 7
|
Grip strength measured with hand-held dynamometer (Jamar).
The different starting condition was pressing freely or pressing after a cue.
|
weeks 2, 3, 4, 5, 6, 7
|
|
Changes in parasympathetic tone measured by heart rate variability
기간: During intervention sessions at weeks 3, 4, 5, 6, 7
|
A sport belt would continuously record the heart rate of patients during physiotherapy sessions.
|
During intervention sessions at weeks 3, 4, 5, 6, 7
|
|
Change in functional connectivity, measured by resting-state fMRI
기간: weeks 0, 8
|
Study the differences in functional connectivity of the brain in patients at the beginning and end of the experimental protocol.
|
weeks 0, 8
|
|
General heath condition questionnaire
기간: week 0
|
Use of the questionnaire SF-36 (Medical Outcomes Study Short Form Health Survey) fill by participants to evaluate their heath condition (score between 0-bad and 100-good).
|
week 0
|
|
Study the evolution of symptom severity score
기간: weeks 1, 2, 3, 4, 5, 6, 7, 8
|
The patients completed the Subjective Evaluation of Symptom Severity (SSS) questionnaire, which uses a continuous scale ranging from 0 (no symptoms) to 100 (the most severe symptoms experienced) for each session.
For the intervention sessions, they fill it twice (before and after the intervention).
|
weeks 1, 2, 3, 4, 5, 6, 7, 8
|
|
Study evolution of perceived stress
기간: weeks 1, 2, 3, 4, 5, 6, 7, 8
|
The patients completed the Perceived Stress Scale (PSS) questionnaire with 4 items, which uses a score from 4 (no stress) to 20 (extremely stressed).
For the intervention sessions, they fill it twice (before and after the intervention).
|
weeks 1, 2, 3, 4, 5, 6, 7, 8
|
|
Study the evolution of the clinical global impression score
기간: weeks 1, 2, 3, 4, 5, 6, 7, 8
|
The investigator will assess the severity of the patient's symptoms using a scale ranging from 0 (normal, not at all unwell) to 7 (among the most severely unwell) at each session.
For the intervention sessions, the evaluation is done twice (before and after the intervention).
|
weeks 1, 2, 3, 4, 5, 6, 7, 8
|
|
Study the evolution of depression evaluation
기간: weeks 2, 8
|
The patients completed the Beck Depression Inventory (BDI-II) questionnaire before and after the intervention period.
The questionnaire uses a score ranging from 0 (not depressed) to 63 (extremely depressed).
|
weeks 2, 8
|
|
Study the evolution of stress evaluation
기간: weeks 2, 8
|
The patients completed the State-Trait Anxiety Inventory (STAI) questionnaire before and after the intervention period.
The questionnaire uses a score ranging from 20 (not stressed) to 80 (extremely stressed) for the state and the trait separetely.
|
weeks 2, 8
|
|
Study the evolution of interoception evaluation
기간: weeks 0, 8
|
The patients completed the Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire before and after the whole protocol.
The questionnaire uses a score ranging from 0 (poor interoceptive sensitivity) to 40 (excellent interoceptive sensitivity).
|
weeks 0, 8
|
|
Study the evolution of functional movement disorders rating scale
기간: weeks 0, 8
|
The investigator performed Simplified Functional Movement Disorders Rating Scale (sFMDRS) questionnaire before and after the intervention period.
The questionnaire uses a score ranging from 0 (no symptoms) to 48 (extremely symptomatic).
|
weeks 0, 8
|
|
Satisfaction rating of physiotherapists on the intervention
기간: At the end of the last intervention session at week 7
|
Physiotherapists will be asked to rate their satisfaction after the intervention on a scale from 1 to 10.
|
At the end of the last intervention session at week 7
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Cristina Concetti, PhD, University of Fribourg
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 7월 1일
기본 완료 (추정된)
2028년 7월 1일
연구 완료 (추정된)
2028년 12월 1일
연구 등록 날짜
최초 제출
2026년 6월 24일
QC 기준을 충족하는 최초 제출
2026년 7월 16일
처음 게시됨 (실제)
2026년 7월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 16일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Participants had the option of signing an informed consent form to allow their coded data to be shared with the scientific community.
At the end of the project, the de-identified raw data would be published in a public repository on the Zenodo platform.
IPD 공유 기간
The public repositories would be made available to the public after the publication date of the relevant scientific article.
IPD 공유 지원 정보 유형
- ANALYTIC_CODE
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. .
Vagial Nerve Stimulation (VNS) active stimulation에 대한 임상 시험
-
University of Malaga아직 모집하지 않음스트레스 | 불명증 | 수면 장애