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Investigating the Neurophysiology of the Motor System and the Feasibility of Vagus Nerve Stimulation in Functional Neurological Disorder (FND) (TMS-VNS)

16. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

  1. Assess baseline neurophysiological differences of the motor system at rest and under different attentional demands, between FND patients and healthy participants.
  2. Compare the motor behaviour of the upper limb (index finger) under different attentional demands, in FND patients and healthy participants.
  3. 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.
  4. 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

  1. Assess the feasibility of the taVNS intervention as an adjunctive treatment in FND.
  2. Determine whether adding taVNS to standard physical therapy improves clinical outcomes (motor symptoms) in FND patients, assessed by clinical scores (CGI, sFMDRS).
  3. 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.
  4. 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.
  5. Assess the effect of taVNS on heart rate and heart rate variability (HRV) in FND patients.
  6. 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.
  7. 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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

68

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Schweiz
    • Canton of Fribourg
      • Fribourg, Canton of Fribourg, Schweiz, 1700
        • University of Fribourg
        • Kontakt:
        • Unterermittler:
          • Michael Mouthon, PhD
        • Kontakt:
        • Unterermittler:
          • Cristina Concetti, PhD
        • Unterermittler:
          • Julia Paratte, Master
        • Unterermittler:
          • Janne Magnin, Bachelor
        • Unterermittler:
          • Sarah Botman, Bachelor

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Patient VNS stimulation intervention
FND patients received a 30 minutes VNS stimulation for 5 sessions during their usual physiotherapy course treatment.
Gerät: Vagial Nerve Stimulation (VNS) active stimulation
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.
Andere Namen:
  • aktiv
  • taVNS
  • tVNS
Schein-Komparator: Patient VNS sham intervention
FND patients received a 30 minutes VNS sham for 5 sessions during their usual physiotherapy course treatment.
Gerät: Vagial Nerve Stimulation (VNS) sham stimulation
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).
Andere Namen:
  • Schein
  • taVNS
  • tVNS
Kein Eingriff: Heathy control without intervention

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Self-reported quality of life
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Neurophysiology investigation of the pathology by comparing Motor-Evoked Potential between FND patients and healthy participant
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Fribourg

Mitarbeiter

Hôpital Cantonal de Fribourg

Ermittler

  • Studienleiter: Cristina Concetti, PhD, University of Fribourg

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Juli 2028

Studienabschluss (Geschätzt)

1. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

24. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Juli 2026

Zuerst gepostet (Tatsächlich)

17. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026-D0047

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

The public repositories would be made available to the public after the publication date of the relevant scientific article.

Art der unterstützenden IPD-Freigabeinformationen

  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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