Functional Movement DisorderVR-FMDNCT06393439
Virtual Reality in Functional Movement Disorder
A study testing Virtual reality motor task in people with Functional Movement Disorder, run by Medical University of Graz at 1 site in Austria.
Trial summary
This study investigates the effect of virtual reality (VR) motor tasks on functional movement disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Movement Disorder
- What is being tested?
- Virtual reality motor task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2024to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis of functional tremor (FT) or essential tremor (ET) or healthy control persons
- In patients with FT and ET: presence of a constant or intermittent tremor during the neurological examination
Who cannot join
- unclear tremor syndrome
- essential tremor plus (ET plus)
- conditions that interfere with EEG diagnostic (skin conditions, skin infections, wounds)
- reflex epilepsy
- cervical degeneration or chronic pain syndrome of the cervical spine
- severe somatic illness
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- previous cerebral or head surgery
- implanted pacemaker or deep brain stimulation
- persons who are unable to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz, Department of Neurology
Graz, 8010
Daniela Kern, MD, +4331638516051, daniela.eibl@medunigraz.at
About this study
Official title: The Effect of Virtual Hand Movements on Functional Tremor - a Pilot Study
This study investigates the effect of virtual reality (VR) motor tasks on functional movement disorders.
Read the detailed description
The investigators want to investigate how different display modes of virtual hands and the experimental manipulation of the visual representation of virtual hand movements affect (1) the performance of the hand movements (2) the tremor and (3) the subjective perception of the tremor.
There are three groups: Patients with functional tremor (FT), patients with essential tremor (ET) and healthy controls (HC). The study is carried out on one or two consecutive days. The first appointment is only made for patients with ET and FT and is used for the neurological examination and to assess the severity of the tremor. It takes place at the Outpatient Clinic for Movement Disorders at the University Clinic for Neurology in Graz and lasts a maximum of 30 minutes. The second appointment is at the Institute of Psychology at the University of Graz and requires the active participation of the respondent for 2.5 hours. Subjects are asked not to take any tremor-influencing medication on the day of the examination. HC will only attend the appointment at the Institute of Psychology.
First appointment:
- Clinical Global Impression - Severity Scale (CGI-S): 5-point Likert scale, clinicians assess the severity of the condition
- Patient Global Impression of Severity (PGI-S): 5-point Likert scale, patients assess the severity of the condition
- Fahn Tolosa Marin Tremor Rating Scale (FTM): assesses the tremor severity
- Simplified Version of the Functional Movement Disorders Rating Scale (S-FMDRS): assesses the severity of the functional tremor
Second appointment:
- Questionnaires:
- Simulator Sickness Questionnaire (SSQ): 4-point Likert scale, assesses nausea, oculomotor and visual disturbances, disorientation (2 timepoints: before and after VR tasks)
- Edinburgh Handedness Inventory (EDI)
- Questionnaire about sociodemographic data
- Technology Usage Inventory (TUI): 7-point Likert scale, acceptance and use of technologies
- Igroup Presence Questionnaire (IPQ): sense of presence in the VR
- electroencephalogram (EEG) and surface-Electromyography (surface-EMG) of forearm muscles: run synchronously with the examinations
- VR-tasks: all tasks are carried out in randomized order
- 3x3 matrix: individual fields light up in random order, participants are instructed to touch the fields in the given sequence as quickly as possible. 30 repetitions with a realistic VR-hand model and 30 repetitions with an abstract VR-hand model.
- 3x3 matrix: same task as (a) but after each repetition, participants must touch a field labeled "next" to continue the task. 30 repetitions.
- apple in a box: a virtual apple is to be placed in a virtual box using the hand with the weaker tremor, while the other hand is left resting on the table. 30 repetitions.
- apple in a box: same task as (c) but the resting hand is not visible. 30 repetitions.
- Conditions
- Functional Movement Disorder
- Being tested
- Virtual reality motor task
- Keywords
- Tremor, Virtual Reality, Functional neurological disorder
- Medical subject headings
- Conversion Disorder, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality motor taskDiagnostic test
After a short practice task, participants perform motor tasks in a virtual reality environment. Reaction time is used to assess task performance.
| Study group | Role | What they receive |
|---|---|---|
| Functional Movement Disorder | Experimental | Not described Receives: Diagnostic Test: Virtual reality motor task |
| Essential Tremor | Experimental | Not described Receives: Diagnostic Test: Virtual reality motor task |
| Healthy Control | Experimental | Not described Receives: Diagnostic Test: Virtual reality motor task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task performance
Reaction time in processing the VR task, measured in seconds
Measured: 4 measurement points: abstract hand model without time pressure, abstract hand model with time pressure, realistic hand model without time pressure, realistic hand model with time pressure. Approximately 2.5 hours
Secondary outcomes (4)
Tremor duration
Duration of tremor during the motor task, expressed as % of movement time (only in FT and ET)
Measured: 5 measurement points: tasks a, b, c, d; Approximately 2.5 hours
EEG
Changes in mu and beta event-related (de)synchronizations between motor tasks and right and left hemispheres
Measured: 10 measurement points: resting state before each motor task and during each motor task; Approximately 2.5 hours
Subjective tremor severity on a visual analogue scale (VAS)
Subjective tremor severity measured by a visual analogue scale (VAS) from 0 to 10 points, with higher scores indicating greater tremor severity
Measured: 6 measurement points: before and after each task; Approximately 2.5 hours
VR acceptance
Technology Usage Inventory (TUI): from 29 to 203 points, with higher scores indicating greater acceptance of technologies
Measured: 2 measurement points: before and after the VR examination, Approximately 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 May 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Movement DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petra Schwingenschuh, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393439
- Sponsor's protocol ID
- 36-115 ex 23/24
- Acronym
- VR-FMD
- Status last verified
- Sep 2025
- First submitted
- 28 Mar 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Hand Movements on Functional Tremor - a Pilot Study
- ClinicalTrials.gov ID
- NCT06393439
- Acronym / sponsor ID
- VR-FMD / 36-115 ex 23/24
- Conditions
- Functional Movement Disorder
- Keywords
- Tremor, Virtual Reality, Functional neurological disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the effect of virtual reality (VR) motor tasks on functional movement disorders.
Detailed description
The investigators want to investigate how different display modes of virtual hands and the experimental manipulation of the visual representation of virtual hand movements affect (1) the performance of the hand movements (2) the tremor and (3) the subjective perception of the tremor.
There are three groups: Patients with functional tremor (FT), patients with essential tremor (ET) and healthy controls (HC). The study is carried out on one or two consecutive days. The first appointment is only made for patients with ET and FT and is used for the neurological examination and to assess the severity of the tremor. It takes place at the Outpatient Clinic for Movement Disorders at the University Clinic for Neurology in Graz and lasts a maximum of 30 minutes. The second appointment is at the Institute of Psychology at the University of Graz and requires the active participation of the respondent for 2.5 hours. Subjects are asked not to take any tremor-influencing medication on the day of the examination. HC will only attend the appointment at the Institute of Psychology.
First appointment:
- Clinical Global Impression - Severity Scale (CGI-S): 5-point Likert scale, clinicians assess the severity of the condition
- Patient Global Impression of Severity (PGI-S): 5-point Likert scale, patients assess the severity of the condition
- Fahn Tolosa Marin Tremor Rating Scale (FTM): assesses the tremor severity
- Simplified Version of the Functional Movement Disorders Rating Scale (S-FMDRS): assesses the severity of the functional tremor
Second appointment:
- Questionnaires:
- Simulator Sickness Questionnaire (SSQ): 4-point Likert scale, assesses nausea, oculomotor and visual disturbances, disorientation (2 timepoints: before and after VR tasks)
- Edinburgh Handedness Inventory (EDI)
- Questionnaire about sociodemographic data
- Technology Usage Inventory (TUI): 7-point Likert scale, acceptance and use of technologies
- Igroup Presence Questionnaire (IPQ): sense of presence in the VR
- electroencephalogram (EEG) and surface-Electromyography (surface-EMG) of forearm muscles: run synchronously with the examinations
- VR-tasks: all tasks are carried out in randomized order
- 3x3 matrix: individual fields light up in random order, participants are instructed to touch the fields in the given sequence as quickly as possible. 30 repetitions with a realistic VR-hand model and 30 repetitions with an abstract VR-hand model.
- 3x3 matrix: same task as (a) but after each repetition, participants must touch a field labeled "next" to continue the task. 30 repetitions.
- apple in a box: a virtual apple is to be placed in a virtual box using the hand with the weaker tremor, while the other hand is left resting on the table. 30 repetitions.
- apple in a box: same task as (c) but the resting hand is not visible. 30 repetitions.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Functional Movement Disorder | Experimental | Diagnostic Test: Virtual reality motor task |
| Essential Tremor | Experimental | Diagnostic Test: Virtual reality motor task |
| Healthy Control | Experimental | Diagnostic Test: Virtual reality motor task |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of functional tremor (FT) or essential tremor (ET) or healthy control persons
- In patients with FT and ET: presence of a constant or intermittent tremor during the neurological examination
Key exclusion criteria (9 listed)
- unclear tremor syndrome
- essential tremor plus (ET plus)
- conditions that interfere with EEG diagnostic (skin conditions, skin infections, wounds)
- reflex epilepsy
- cervical degeneration or chronic pain syndrome of the cervical spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality motor taskAfter a short practice task, participants perform motor tasks in a virtual reality environment. Reaction time is used to assess task performance. | Diagnostic test | Essential Tremor, Functional Movement Disorder, Healthy Control |
Primary outcome
Task performance
Time frame: 4 measurement points: abstract hand model without time pressure, abstract hand model with time pressure, realistic hand model without time pressure, realistic hand model with time pressure. Approximately 2.5 hours
Reaction time in processing the VR task, measured in seconds
4 secondary outcomes
Tremor duration
Time frame: 5 measurement points: tasks a, b, c, d; Approximately 2.5 hours
EEG
Time frame: 10 measurement points: resting state before each motor task and during each motor task; Approximately 2.5 hours
Subjective tremor severity on a visual analogue scale (VAS)
Time frame: 6 measurement points: before and after each task; Approximately 2.5 hours
VR acceptance
Time frame: 2 measurement points: before and after the VR examination, Approximately 2.5 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petra Schwingenschuh, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality motor task in people with Functional Movement Disorder, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela Kern, MD (004331638516051, daniela.eibl@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Task performance (time frame: 4 measurement points: abstract hand model without time pressure, abstract hand model with time pressure, realistic hand model without time pressure, realistic hand model with time pressure. Approximately 2.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.