Clinical trial NCT06017908: Identification of Visual Dependence in PPPD Patients With the Aid of Virtual Reality.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PPPD
Keywords: Virtual Reality
PPPD
Rod and Disc Test
Optokinetic after nystagmus
Visual dependence
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Intervention of the Virtual Reality goggles will be evaluated in a small clinical trial to determine the feasibility of the product.
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Device feasibility
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels
Study officials:
affiliation: Free University of Brussels
name: Vedat Topsakal, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References: