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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: PPPD
• Intervention / Treatment: Device: Optokinetic stimulation through Virtual Reality

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie Reynders, MD; Phone Number: +32477261213; Email: marie.reynders@uzbrussel.be
• Study Contact Backup: Name: Vedat Topsakal, Prof, MD; Email: vedat.topsakal@uzbrussel.be

Study Locations

• Belgium
  • Brussels
    • Jette, Brussels, Belgium, 1090
      • Recruiting
      • Universitair Ziekenhuis Brussel
      • Contact: Irina De Clus; Email: Irina.DeClus@uzbrussel.be
      • Principal Investigator: Marie Reynders, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All patients with chronic vertigo (>3 months)

Exclusion Criteria:

• Minors
• Patients with a history of epilepsy.
• Patients with an alcohol use disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device feasibility	Time constant and velocity of eye movements	1 year

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Vedat Topsakal, Prof, MD, Free University of Brussels

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Virtual Reality; PPPD; Visual dependence; Rod and Disc Test; Optokinetic after nystagmus
• Other Study ID Numbers: 23079_OKAN

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