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Recruiting NCT06393439

Virtual Reality in Functional Movement Disorder

No phase Interventional Functional Movement Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual reality motor task.
Who it may be relevant to
Registry conditions: Functional Movement Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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:

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

Austria · 1 center
  • Medical University of Graz, Department of Neurology — Graz

Identifiers

NCT: NCT06393439 · 36-115 ex 23/24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗