Investigating the Neurophysiology of the Motor System and the Feasibility of Vagus Nerve Stimulat… (NCT07710677) | Clinical Trial Compass
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Investigating the Neurophysiology of the Motor System and the Feasibility of Vagus Nerve Stimulation in Functional Neurological Disorder (FND)
Switzerland68 participantsStarted 2026-07-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Self-reported quality of life
Timeframe: For each intervention session at weeks 3, 4, 5, 6, 7