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

NCT06017908 | Unknown

• 1 other identifier: 23079_OKAN
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

PPPD

Keywords

Virtual Reality; PPPD; Rod and Disc Test; Optokinetic after nystagmus; Visual dependence

Outcome Measures

Primary Outcomes (1)

• Device feasibility

  Time constant and velocity of eye movements

  1 year

Study Arms (2)

PPPD patients

EXPERIMENTAL

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

Device: Optokinetic stimulation through Virtual Reality

Healthy patients

EXPERIMENTAL

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

Device: Optokinetic stimulation through Virtual Reality

Interventions

Optokinetic stimulation through Virtual Reality 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; PPPD patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

Study Officials

• Vedat Topsakal, Prof, MD

  Free University of Brussels

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Reynders, MD

CONTACT

+32477261213; marie.reynders@uzbrussel.be

Vedat Topsakal, Prof, MD

CONTACT

vedat.topsakal@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention of the Virtual Reality goggles will be evaluated in a small clinical trial to determine the feasibility of the product.

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: August 30, 2023
• Study Start: February 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: July 30, 2024
• Last Updated: January 31, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)