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Could a gentle ear zap boost physiotherapy for a mysterious brain disorder?

NCT ID NCT07710677

Symptom relief Sponsor: University of Fribourg Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study investigates whether adding a painless, non-invasive vagus nerve stimulation through the ear to standard physiotherapy can improve motor symptoms and quality of life in people with Functional Neurological Disorder (FND). Researchers will first compare brain function in FND patients and healthy volunteers using TMS and fMRI. Then, FND patients will be randomly assigned to receive either real or sham stimulation during five physiotherapy sessions, with neither they nor the researchers knowing which group they are in. The goal is to see if the real stimulation leads to better outcomes than physiotherapy alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a non-invasive vagus nerve stimulation device that delivers gentle electric pulses to the ear
What this could lead to
If it works, this could point toward a new way to enhance physiotherapy for people with Functional Neurological Disorder, potentially improving motor symptoms and quality of life.
What could go wrong
This is an early feasibility study with a small number of participants, so results may not be conclusive. The sham-controlled design helps, but the treatment may show no added benefit over physiotherapy alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 68 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

conversion disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Functional neurological disorder Motor symptoms

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Fribourg

    Fribourg, Canton of Fribourg, 1700, Switzerland

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