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NCT Number: NCT06393439

Virtual Reality in Functional Movement Disorder

This study investigates the effect of virtual reality (VR) motor tasks on functional movement disorders.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz, Department of Neurology

Graz, 8010, Austria

Location status: Recruiting

Location contact

Daniela Kern, MD

CONTACT

[email protected]

+4331638516051

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality motor task

Diagnostic Test

After a short practice task, participants perform motor tasks in a virtual reality environment. Reaction time is used to assess task performance.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Kern, MD

CONTACT

[email protected]

004331638516051

Petra Schwingenschuh, MD

CONTACT

[email protected]

004331638583379

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

The Effect of Virtual Hand Movements on Functional Tremor - a Pilot Study

Acronym: VR-FMD

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 1, 2024
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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