Neurological DisordersVIRADIANCT07268079
Validation of the VIRADIA App for Neurological and Cognitive Diagnostics in Virtual Reality
An observational study of Neurological Disorders and Cognitive Impairment, run by Gametherapy at 1 site in Slovakia.
Trial summary
The VIRADIA study aims to validate and assess the reliability of a newly developed Virtual Reality (VR) diagnostic platform designed for neurological and cognitive testing. The goal is to determine whether the VR versions of nine commonly used clinical tests measure the same constructs and provide comparable results… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurological Disorders, Cognitive Impairment, Motor Impairment
- What is being tested?
- VIRADIA - Virtual Reality Diagnostic Platform
- How many people
- 200 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Dec 2025to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 18-80 years, including healthy volunteers and patients with neurological diagnoses recruited from outpatient neurology clinics and community sources in Nitra, Slovakia. Participants are screened for eligibility, provide informed consent, and complete both standard and Virtual Reality versions of diagnostic tests.
Who may be able to join
- Age 18-80 years.
- Ability to provide informed consent.
- Adequate vision and hearing to complete testing.
- For the neurological group: confirmed diagnosis of a neurological disorder (e.g., Parkinson's disease, multiple sclerosis, or similar).
- For the control group: no history of neurological or psychiatric disease.
Who cannot join
- Severe cognitive impairment (MMSE < 24 or equivalent clinical judgment).
- Acute neurological or psychiatric condition interfering with testing.
- Severe motor disability preventing task performance (e.g., inability to use VR controller).
- Current substance abuse.
- Uncorrected visual impairment or vestibular disorder leading to intolerance of VR.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia1 site, 1 recruiting
- Recruiting
INNER s.r.o., Fatranská 873/12, 94901 Nitra
Nitra, Nitra Region, 94901
Ingrid Menkyova, MD, PhD., +421949173540, ingridmenky@gmail.com
About this study
Official title: Validation Study of VIRADIA: A Virtual Reality Diagnostic Platform for the Assessment of Neurological and Cognitive Functions
The VIRADIA study aims to validate and assess the reliability of a newly developed Virtual Reality (VR) diagnostic platform designed for neurological and cognitive testing. The goal is to determine whether the VR versions of nine commonly used clinical tests measure the same constructs and provide comparable results to their traditional face-to-face or paper-based forms.
The study includes two groups of participants: (1) healthy volunteers and (2) patients with neurological diagnoses. Each participant will complete both the standard and the VR versions of the tests, with the order of administration randomly assigned. The tested functions cover fine motor skills, gait and balance, attention, executive function, processing speed, and visuospatial abilities.
Read more
The following tests are included in the VR platform: 9-Hole Peg Test (9HPT), 6 Meter Walk Test, Timed Up and Go - Manual (TUG-M), Functional Reach Test (FRT), Symbol Digit Modalities Test (SDMT), Clock Drawing Test (CDT), Trail Making Test (TMT A/B), Stroop Test, and SATURN Test.
Participants will first provide informed consent and basic demographic information. They will then complete all tests in both modalities (standard and VR), with appropriate breaks between tasks.
The study is observational, within-subjects, and paired in design. Primary outcomes include correlation and agreement between VR and standard test scores (validity). Data will be analyzed using paired statistical methods, including Pearson/Spearman correlations, Bland-Altman analysis, and Intraclass Correlation Coefficients (ICC).
No medication or invasive intervention is used in this study. The VR testing is non-invasive and carries minimal risk. The study has been approved by the Ethics Committee of the Nitra Self-Governing Region (Approval No. 09I05-03-804).
The results will provide evidence for the validity and reliability of VR-based diagnostics and support the use of the VIRADIA platform as a safe, standardized tool for neurological and cognitive assessment.
Read the detailed description
The VIRADIA validation study investigates the psychometric properties-validity and reliability-of a Virtual Reality (VR) diagnostic platform designed for neurological and cognitive assessment. The platform includes VR adaptations of nine established clinical tests commonly used in neurology and neuropsychology. These tests evaluate fine motor coordination, gait and balance, processing speed, attention, and executive functioning.
The study follows an observational, within-subjects, paired design. Each participant completes both the standard (paper-based or face-to-face) version and the corresponding VR version of all tests. The order of modalities is counterbalanced across participants to control for order effects. Two groups are enrolled:
- Healthy adults (control group)
- Patients with neurological conditions (clinical group; one priority diagnosis in the first phase)
Objectives
- To evaluate the convergent validity of VR-based test scores compared to standard clinical versions.
- To analyze discriminative validity, i.e., whether VR test results can differentiate between healthy individuals and neurological patients comparably to standard methods.
Procedures
After informed consent, demographic and clinical data (age, gender, education, diagnosis, medication) are recorded. Participants complete all tests under both conditions (standard and VR). After testing, participants fill out a short questionnaire on VR tolerability and subjective experience.
Data Collection and Sample Size
The study aims to include 200 participants (100 healthy, 100 patients). The target sample size was determined using a priori power analysis for paired ROC/AUC comparisons (AUC ≥ 0.75, ΔAUC ≤ 0.05, α = 0.05, power = 0.90), with an additional 15% margin for attrition.
Statistical Analyses
- Convergent validity: Pearson/Spearman correlations (95% CI) between VR and standard scores.
- Agreement: Paired t-tests/Wilcoxon tests and Bland-Altman plots (bias, 95% limits of agreement).
- Discriminative validity: ROC/AUC analysis comparing patients and healthy participants.
- Reliability: Intraclass Correlation Coefficient (ICC[2,1]) for the test-retest subsample.
Ethical Considerations
The study is non-invasive and presents minimal risk. No experimental drug, device, or biological material is used. All participants provide informed consent prior to participation. The study has been approved by the Ethics Committee of the Nitra Self-Governing Region (Approval No. 09I05-03-804).
Expected Outcomes
The study will produce empirical evidence supporting the validity, reliability, and clinical utility of the VIRADIA platform. This validation will enable the integration of standardized VR-based diagnostics into neurological practice and contribute to early detection of neurodegenerative disorders in both clinical and home settings.
- Conditions
- Neurological Disorders, Cognitive Impairment, Motor Impairment, Neurodegenerative Diseases
- Being tested
- VIRADIA - Virtual Reality Diagnostic Platform
- Keywords
- Virtual Reality, Neurological Diagnostics, Cognitive Assessment, Motor Function, Neuropsychology, Validity, Digital Health
- Medical subject headings
- Nervous System Diseases, Cognitive Dysfunction, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIRADIA - Virtual Reality Diagnostic PlatformDiagnostic test
Participants complete a series of diagnostic tests in the VIRADIA virtual reality environment.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Healthy adult volunteers without known neurological or psychiatric conditions. Participants complete both the standard (paper-based or face-to-face) and Virtual Reality (VR) versions of all diagnostic tests. Receives: Diagnostic Test: VIRADIA - Virtual Reality Diagnostic Platform | |
| Neurological Patients | Adults with a confirmed neurological diagnosis (e.g., Parkinson's disease or related motor/cognitive disorder). Participants complete both the standard and Virtual Reality versions of the diagnostic tests. Receives: Diagnostic Test: VIRADIA - Virtual Reality Diagnostic Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Virtual Reality (VR) and Standard Test Scores
Convergent validity will be assessed by correlating participants' performance on the VR versions of nine diagnostic tests (9HPT, 25FWT, TUG-M, FRT, SDMT, CDT, TMT-A/B, Stroop, and SATURN) with their corresponding standard (paper or face-to-face) versions.
Measured: Single assessment on Day 1 (one testing session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological DisordersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gametherapy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingrid Menkyova, MD, PhD., Principal investigatorMartin Polak, Dr., Principal investigator, Gametherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268079
- Sponsor's protocol ID
- 09I05-03-V04
- Other IDs
- 09I05-03-V04
- Acronym
- VIRADIA
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the dataset contains sensitive clinical and neurological information collected under local ethics approval for internal validation purposes only. Aggregate data and statistical results will be published in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of VIRADIA: A Virtual Reality Diagnostic Platform for the Assessment of Neurological and Cognitive Functions
- ClinicalTrials.gov ID
- NCT07268079
- Acronym / sponsor ID
- VIRADIA / 09I05-03-V04
- Conditions
- Neurological Disorders, Cognitive Impairment, Motor Impairment, Neurodegenerative Diseases
- Keywords
- Virtual Reality, Neurological Diagnostics, Cognitive Assessment, Motor Function, Neuropsychology, Validity, Digital Health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- GametherapyUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 5 Dec 2025 (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 VIRADIA study aims to validate and assess the reliability of a newly developed Virtual Reality (VR) diagnostic platform designed for neurological and cognitive testing. The goal is to determine whether the VR versions of nine commonly used clinical tests measure the same constructs and provide comparable results to their traditional face-to-face or paper-based forms.
The study includes two groups of participants: (1) healthy volunteers and (2) patients with neurological diagnoses. Each participant will complete both the standard and the VR versions of the tests, with the order of administration randomly assigned. The tested functions cover fine motor skills, gait and balance, attention, executive function, processing speed, and visuospatial abilities.
The following tests are included in the VR platform: 9-Hole Peg Test (9HPT), 6 Meter Walk Test, Timed Up and Go - Manual (TUG-M), Functional Reach Test (FRT), Symbol Digit Modalities Test (SDMT), Clock Drawing Test (CDT), Trail Making Test (TMT A/B), Stroop Test, and SATURN Test.
Participants will first provide informed consent and basic demographic information. They will then complete all tests in both modalities (standard and VR), with appropriate breaks between tasks.
The study is observational, within-subjects, and paired in design. Primary outcomes include correlation and agreement between VR and standard test scores (validity). Data will be analyzed using paired statistical methods, including Pearson/Spearman correlations, Bland-Altman analysis, and Intraclass Correlation Coefficients (ICC).
No medication or invasive intervention is used in this study. The VR testing is non-invasive and carries minimal risk. The study has been approved by the Ethics Committee of the Nitra Self-Governing Region (Approval No. 09I05-03-804).
The results will provide evidence for the validity and reliability of VR-based diagnostics and support the use of the VIRADIA platform as a safe, standardized tool for neurological and cognitive assessment.
Detailed description
The VIRADIA validation study investigates the psychometric properties-validity and reliability-of a Virtual Reality (VR) diagnostic platform designed for neurological and cognitive assessment. The platform includes VR adaptations of nine established clinical tests commonly used in neurology and neuropsychology. These tests evaluate fine motor coordination, gait and balance, processing speed, attention, and executive functioning.
The study follows an observational, within-subjects, paired design. Each participant completes both the standard (paper-based or face-to-face) version and the corresponding VR version of all tests. The order of modalities is counterbalanced across participants to control for order effects. Two groups are enrolled:
- Healthy adults (control group)
- Patients with neurological conditions (clinical group; one priority diagnosis in the first phase)
Objectives
- To evaluate the convergent validity of VR-based test scores compared to standard clinical versions.
- To analyze discriminative validity, i.e., whether VR test results can differentiate between healthy individuals and neurological patients comparably to standard methods.
Procedures
After informed consent, demographic and clinical data (age, gender, education, diagnosis, medication) are recorded. Participants complete all tests under both conditions (standard and VR). After testing, participants fill out a short questionnaire on VR tolerability and subjective experience.
Data Collection and Sample Size
The study aims to include 200 participants (100 healthy, 100 patients). The target sample size was determined using a priori power analysis for paired ROC/AUC comparisons (AUC ≥ 0.75, ΔAUC ≤ 0.05, α = 0.05, power = 0.90), with an additional 15% margin for attrition.
Statistical Analyses
- Convergent validity: Pearson/Spearman correlations (95% CI) between VR and standard scores.
- Agreement: Paired t-tests/Wilcoxon tests and Bland-Altman plots (bias, 95% limits of agreement).
- Discriminative validity: ROC/AUC analysis comparing patients and healthy participants.
- Reliability: Intraclass Correlation Coefficient (ICC[2,1]) for the test-retest subsample.
Ethical Considerations
The study is non-invasive and presents minimal risk. No experimental drug, device, or biological material is used. All participants provide informed consent prior to participation. The study has been approved by the Ethics Committee of the Nitra Self-Governing Region (Approval No. 09I05-03-804).
Expected Outcomes
The study will produce empirical evidence supporting the validity, reliability, and clinical utility of the VIRADIA platform. This validation will enable the integration of standardized VR-based diagnostics into neurological practice and contribute to early detection of neurodegenerative disorders in both clinical and home settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Diagnostic Test: VIRADIA - Virtual Reality Diagnostic PlatformHealthy adult volunteers without known neurological or psychiatric conditions. Participants complete both the standard (paper-based or face-to-face) and Virtual Reality (VR) versions of all diagnostic tests. |
| Neurological Patients | – | Diagnostic Test: VIRADIA - Virtual Reality Diagnostic PlatformAdults with a confirmed neurological diagnosis (e.g., Parkinson's disease or related motor/cognitive disorder). Participants complete both the standard and Virtual Reality versions of the diagnostic tests. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18-80 years, including healthy volunteers and patients with neurological diagnoses recruited from outpatient neurology clinics and community sources in Nitra, Slovakia. Participants are screened for eligibility, provide informed consent, and complete both standard and Virtual Reality versions of diagnostic tests.
Key inclusion criteria (5 listed)
- Age 18-80 years.
- Ability to provide informed consent.
- Adequate vision and hearing to complete testing.
- For the neurological group: confirmed diagnosis of a neurological disorder (e.g., Parkinson's disease, multiple sclerosis, or similar).
- For the control group: no history of neurological or psychiatric disease.
Key exclusion criteria (5 listed)
- Severe cognitive impairment (MMSE < 24 or equivalent clinical judgment).
- Acute neurological or psychiatric condition interfering with testing.
- Severe motor disability preventing task performance (e.g., inability to use VR controller).
- Current substance abuse.
- Uncorrected visual impairment or vestibular disorder leading to intolerance of VR.
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 |
|---|---|---|
| VIRADIA - Virtual Reality Diagnostic PlatformParticipants complete a series of diagnostic tests in the VIRADIA virtual reality environment. | Diagnostic test | Healthy controls, Neurological Patients |
Primary outcome
Correlation Between Virtual Reality (VR) and Standard Test Scores
Time frame: Single assessment on Day 1 (one testing session)
Convergent validity will be assessed by correlating participants' performance on the VR versions of nine diagnostic tests (9HPT, 25FWT, TUG-M, FRT, SDMT, CDT, TMT-A/B, Stroop, and SATURN) with their corresponding standard (paper or face-to-face) versions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset contains sensitive clinical and neurological information collected under local ethics approval for internal validation purposes only. Aggregate data and statistical results will be published in peer-reviewed journals.
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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.
Ingrid Menkyova, MD, PhD. principal investigator
Martin Polak, Dr. principal investigator
Gametherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurological Disorders and Cognitive Impairment, run by Gametherapy at 1 site in Slovakia.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Dec 2025. 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 Slovakia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Polak, Dr. (+421915546098, martin@gametherapy.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Virtual Reality (VR) and Standard Test Scores (time frame: Single assessment on Day 1 (one testing session)). 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 5 Dec 2025.