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

NCT ID: NCT06017908

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-07-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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PPPD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Intervention of the Virtual Reality goggles will be evaluated in a small clinical trial to determine the feasibility of the product.
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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PPPD patients

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

Group Type EXPERIMENTAL

Optokinetic stimulation through Virtual Reality

Intervention Type DEVICE

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.

Healthy patients

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

Group Type EXPERIMENTAL

Optokinetic stimulation through Virtual Reality

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients with chronic vertigo (\>3 months)

Exclusion Criteria

* Minors
* Patients with a history of epilepsy.
* Patients with an alcohol use disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vedat Topsakal, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Free University of Brussels

Locations

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Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Marie Reynders, MD

Role: CONTACT

+32477261213

Vedat Topsakal, Prof, MD

Role: CONTACT

Facility Contacts

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Irina De Clus

Role: primary

Other Identifiers

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23079_OKAN

Identifier Type: -

Identifier Source: org_study_id

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