OKAN: Identification of Visual Dependence in PPPD Patients With the Aid of Virtual Reality.

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06017908
Collaborator
(none)
10
2
10

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate whether increased visual dependence can be identified with the help of Virtual Reality (VR). Increased visual dependence is a general term for patients with increased dependence on vision in maintaining their balance. Patients suffering from persistent postural perceptual vertigo (PPPD) often suffer from increased visual dependence. This in turn leads to complaints such as visual vertigo, agoraphobia and fear of falling. Visual dependence is normally measured using the optokinetic after nystagmus (OKAN) and the rod and disc test (RDT). In this study, these two tests are performed with the aid of Virtual Reality.

Condition or Disease Intervention/Treatment Phase
  • Device: Optokinetic stimulation through Virtual Reality
N/A

Detailed Description

The aim of this study is to evaluate whether increased visual dependence can be identified with the help of Virtual Reality (VR). Visual dependence is normally measured using the optokinetic after nystagmus (OKAN) and the rod and disc test (RDT). In this study, these two tests are performed with the aid of Virtual Reality. The OKAN is measured by eye tracking, a key item already used daily in instruments such as video nystagmography (VNG) and video head impulse test (vHIT). Another test representative of visual dependence is the Rod and Disc test (RDT). In the RDT, patients are asked to complete a visual task so that researchers gain more knowledge about visual dependence. Until now, these tests have been performed using a large set-up and many different materials. Moreover, the exact underlying mechanism of visual dependence in PPPD patients is still unknown. The aim of this study is to investigate whether Virtual Reality can be a useful tool when performing the OKAN and RDT. In this way, a better understanding of visual dependence is sought. This study aims to determine the normative values for the OKAN and RDT performed with the aid of Virtual Reality. Therefore, a healthy group of individuals will be compared with PPPD patients as they suffer from visual dependence. To evaluate the effectiveness of the OKAN and RDT via VR, the results will be compared with the scores of the visual vertigo analogue scale (VVAS), a questionnaire to assess visual dependence.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Intervention of the Virtual Reality goggles will be evaluated in a small clinical trial to determine the feasibility of the product.Intervention of the Virtual Reality goggles will be evaluated in a small clinical trial to determine the feasibility of the product.
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Identification of Visual Dependence in PPPD Patients With an Enhanced Rod and Disc Test (RDT) and Optokinetic After Nystagmus (OKAN) With the Aid of Virtual Reality.
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Jul 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: PPPD patients

Virtual Reality will be used to execute the RDT and OKAN in PPPD patients.

Device: Optokinetic stimulation through Virtual Reality
The experiment will be conducted in two phases. In the first experiment the patients will be passively watch the visual images while seated. An optokinetic stimulus will be delivered through the VR headset by displaying rotating visual patterns. In the second trial they will have to perform the enhanced rod and disc test.

Experimental: Healthy patients

Virtual Reality will be used to execute the RDT and OKAN in healthy PPPD patients.

Device: Optokinetic stimulation through Virtual Reality
The experiment will be conducted in two phases. In the first experiment the patients will be passively watch the visual images while seated. An optokinetic stimulus will be delivered through the VR headset by displaying rotating visual patterns. In the second trial they will have to perform the enhanced rod and disc test.

Outcome Measures

Primary Outcome Measures

  1. Device feasibility [1 year]

    Time constant and velocity of eye movements

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • All patients with chronic vertigo (>3 months)
Exclusion Criteria:
  • Minors

  • Patients with a history of epilepsy.

  • Patients with an alcohol use disorder

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Vedat Topsakal, Prof, MD, Free University of Brussels

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT06017908
Other Study ID Numbers:
  • 23079_OKAN
First Posted:
Aug 30, 2023
Last Update Posted:
Aug 30, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universitair Ziekenhuis Brussel

Study Results

No Results Posted as of Aug 30, 2023