PPPDOKANNCT06017908
Identification of Visual Dependence in PPPD Patients With the Aid of Virtual Reality.
A study testing Optokinetic stimulation through Virtual Reality in people with PPPD, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- PPPD
- What is being tested?
- Optokinetic stimulation through Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2024to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients with chronic vertigo (>3 months)
Who cannot join
- Minors
- Patients with a history of epilepsy.
- Patients with an alcohol use disorder
Trial locations and contacts
1 site in 1 country.
Vedat Topsakal, Prof, MD contact
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090
Irina De Clus, Irina.DeClus@uzbrussel.be
Marie Reynders, MD
About this study
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.
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.
Read the 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.
- Conditions
- PPPD
- Being tested
- Optokinetic stimulation through Virtual Reality
- Keywords
- Virtual Reality, PPPD, Rod and Disc Test, Optokinetic after nystagmus, Visual dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optokinetic stimulation through Virtual RealityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PPPD patients | Experimental | Virtual Reality will be used to execute the RDT and OKAN in PPPD patients. Receives: Device: Optokinetic stimulation through Virtual Reality |
| Healthy patients | Experimental | Virtual Reality will be used to execute the RDT and OKAN in healthy PPPD patients. Receives: Device: Optokinetic stimulation through Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device feasibility
Time constant and velocity of eye movements
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Feb 2024 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PPPDStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vedat Topsakal, Prof, MD, Principal investigator, Free University of Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017908
- Sponsor's protocol ID
- 23079_OKAN
- Acronym
- OKAN
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06017908
- Acronym / sponsor ID
- OKAN / 23079_OKAN
- Conditions
- PPPD
- Keywords
- Virtual Reality, PPPD, Rod and Disc Test, Optokinetic after nystagmus, Visual dependence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention of the Virtual Reality goggles will be evaluated in a small clinical trial to determine the feasibility of the product.
| Arm | Type | Receives |
|---|---|---|
| PPPD patients | Experimental | Device: Optokinetic stimulation through Virtual RealityVirtual Reality will be used to execute the RDT and OKAN in PPPD patients. |
| Healthy patients | Experimental | Device: Optokinetic stimulation through Virtual RealityVirtual Reality will be used to execute the RDT and OKAN in healthy PPPD patients. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with chronic vertigo (>3 months)
Key exclusion criteria (3 listed)
- Minors
- Patients with a history of epilepsy.
- Patients with an alcohol use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optokinetic stimulation through Virtual RealityThe 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. | Device | Healthy patients, PPPD patients |
Primary outcome
Device feasibility
Time frame: 1 year
Time constant and velocity of eye movements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vedat Topsakal, Prof, MD contact
Vedat Topsakal, Prof, MD principal investigator
Free University of Brussels
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optokinetic stimulation through Virtual Reality in people with PPPD, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Reynders, MD (+32477261213, marie.reynders@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device feasibility (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.