NCT06393439

Brief Summary

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

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

March 28, 2024

Last Update Submit

September 23, 2025

Conditions

Keywords

TremorVirtual RealityFunctional neurological disorder

Outcome Measures

Primary Outcomes (1)

  • Task performance

    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 Outcomes (4)

  • Tremor duration

    5 measurement points: tasks a, b, c, d; Approximately 2.5 hours

  • EEG

    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)

    6 measurement points: before and after each task; Approximately 2.5 hours

  • VR acceptance

    2 measurement points: before and after the VR examination, Approximately 2.5 hours

Study Arms (3)

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

Interventions

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

Essential TremorFunctional Movement DisorderHealthy Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz, Department of Neurology

Graz, 8010, Austria

RECRUITING

MeSH Terms

Conditions

Conversion DisorderTremor

Condition Hierarchy (Ancestors)

Somatoform DisordersMental DisordersDyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Petra Schwingenschuh, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2024

First Posted

May 1, 2024

Study Start

May 1, 2024

Primary Completion

December 31, 2025

Study Completion

March 30, 2026

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations