Virtual Reality in Functional Movement Disorder (VR-FMD)

September 23, 2025 updated by: Medical University of Graz

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. 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
  2. electroencephalogram (EEG) and surface-Electromyography (surface-EMG) of forearm muscles: run synchronously with the examinations

  3. VR-tasks: all tasks are carried out in randomized order

    1. 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.
    2. 3x3 matrix: same task as (a) but after each repetition, participants must touch a field labeled "next" to continue the task. 30 repetitions.
    3. 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.
    4. apple in a box: same task as (c) but the resting hand is not visible. 30 repetitions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
      • Graz, Austria, 8010
        • Recruiting
        • Medical University of Graz, Department of Neurology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • previous cerebral or head surgery
  • implanted pacemaker or deep brain stimulation
  • persons who are unable to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Functional Movement Disorder
Diagnostic test: Virtual reality motor task
After a short practice task, participants perform motor tasks in a virtual reality environment. Reaction time is used to assess task performance.
Experimental: Essential Tremor
Diagnostic test: Virtual reality motor task
After a short practice task, participants perform motor tasks in a virtual reality environment. Reaction time is used to assess task performance.
Experimental: Healthy Control
Diagnostic test: Virtual reality motor task
After a short practice task, participants perform motor tasks in a virtual reality environment. Reaction time is used to assess task performance.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tremor duration
Time Frame: 5 measurement points: tasks a, b, c, d; Approximately 2.5 hours
Duration of tremor during the motor task, expressed as % of movement time (only in FT and ET)
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
Changes in mu and beta event-related (de)synchronizations between motor tasks and right and left hemispheres
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
Subjective tremor severity measured by a visual analogue scale (VAS) from 0 to 10 points, with higher scores indicating greater tremor severity
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
Technology Usage Inventory (TUI): from 29 to 203 points, with higher scores indicating greater acceptance of technologies
2 measurement points: before and after the VR examination, Approximately 2.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Graz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Petra Schwingenschuh, MD, Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 36-115 ex 23/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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