An interventional study of Postural Response upon physical optokinetic stimulation and Postural Response upon virtual optokinetic stimulation in Dizziness, Concussion (Diagnosis) and Traumatic Brain Injury, sponsored by Dominik Straumann. Recruiting at 2 sites in Switzerland. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Dominik Straumann · Not applicable, Interventional, and Diagnostic
This research project aims to measure how balance is affected by special visual stimulation. Dizziness caused by complex moving visual patterns, known as optokinetic stimulation, is usually called visually induced dizziness (VID).
The study includes patients with persistent symptoms after a concussion and those with non-traumatic dizziness. Healthy participants serve as a control group for the comparison of balance and symptom responses.
The optokinetic stimulation is done using either a physical rotating disk or a virtual reality (VR) headset. The visual effects are created by bright moving dots. During the stimulation, these patterns move in a specific manner and directions while the subject's balance is recorded. Symptoms such as dizziness, headache, and nausea are also documented.
The goal of this project is to improve objective diagnosis of VID. By comparing patients and healthy subjects, the study aim to assess the severity of the disorder. It is also assumed that using different visual stimuli during the balance assessment will offer more sensitive and accurate results.
In the long term, this innovative assessment method shall support clinicians to establish the diagnosis of VID, and improve the treatment and management of patients with VID.
Sport-related concussion (SRC) refers to traumatic head injuries caused by direct biomechanical forces to the head, neck or body during physical activity. Due to very heterogeneous clinical patterns in concussed patients including multiple clinical profiles and subtypes, standardised diagnosis for SRC is still in scope of research. Thus, diagnostic procedures are currently based on clinical examination and subjective complaints using questionnaires, while objective assessments supporting a diagnosis for concussed patients are lacking. Only some functional limitations are recorded via objective methods, but no quantification and no diagnosis are possible.
Common questionnaires to assess VID in concussed patients and for vestibular disorders are the visual vertigo analogue scale (VVAS), and the situational vertigo questionnaire (SVQ), though there exist more. The dizziness handicap inventory (DHI) is used to classify the general aspect of dizziness. Other methods to support VID diagnosis have been developed including subjective visual vertical assessment or balance screenings with optokinetic stimulation. Such objective findings are essential for a reliable diagnosis supporting subjective complaints. However, determined parameters and observed pathologies vary among studies and thus, a classification via objective assessments in VID patients is still in scope of research. Nevertheless, symptom assessment is still considered as one of the best and reliable method to support diagnosis and success in treatment.
Outcomes of previously discussed and used questionnaires to assess VID rely on patients' compliance. Subjective evaluations on dizziness are challenging for patients and may therefore diverge from objective measurements. In addition, questionnaires do not explicitly distinguish between vertigo and dizziness. Moreover, self-reported symptoms showed moderate correlation to objective findings. This highlights the importance of realising objective methods such as balance assessments.
Some objective assessments to identify VID, and to discriminate among patient groups and healthy subjects have been introduced. But most of the studies investigating VID examined a broad variety of vestibular disorders, rarely including concussion.
Concerning balance assessment combined with optokinetic stimulation, several studies found significant differences among control groups and patients with vestibular disorders and dizziness, but findings varied across calculated parameters. Overall, mean deviations on sway path tended to be more predictive than lean sway, and significant effects are supposed to be in stimulated planes. Additionally for path length, there exists two quotients representing the balance response ratio between eyes open and eyes closed (Romberg quotient), and the ratio between eyes open and optokinetic stimulation (optokinetic quotient), which both showed significant effects comparing healthy subjects and visual vertigo patients. However, parameters evaluated from velocity were often in favour compared to path length. Furthermore, prolonged exposure to optokinetic stimulation triggered symptoms in patients with visual vestibular mismatch but not in control subjects, supporting the hypotheses of symptom exacerbation by visual motion. Regarding defined triggers for VID, one could assume that triggers are based on an individual level and therefore include various visual motion conditions such as complex, large-field or moving elements in order to conflict one's sensory integration. Given those multidimensional conditions for an assessment, the use of VR environments for this project benefits a broad and flexible range in VID assessment. Regarding the mentioned studies, one could assume that balance evaluation on multiple optokinetic stimuli and comparison to reference values based on healthy subjects has the potential to increase the sensitivity of the balance screening for VID subjects, and in particular concussed patients.
This project aims to generate greater reliability using a more differentiated balance assessment with optokinetic stimulation. Findings are assumed to help identifying potential VID on a more individual basis and support accurate classification.
226 studies on the registry are indexed under Dizziness; 56 are open to participants now.
This study's planned enrollment of 240 is above the median of 43 across 170 interventional studies indexed under Dizziness.
Browse Dizziness studies →This is the only study on the registry with Dominik Straumann as lead sponsor.
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Exclusion Criteria:
Balance issues not dizziness-related, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cross-over design for healthy subjects, physical optokinetic stimulation in advance to virtual optokinetic stimulation.
Diagnostic Test: Postural Response upon physical optokinetic stimulation · Diagnostic Test: Postural Response upon virtual optokinetic stimulation
Cross-over design for healthy subjects, virtual optokinetic stimulation in advance to physical optokinetic stimulation.
Diagnostic Test: Postural Response upon physical optokinetic stimulation · Diagnostic Test: Postural Response upon virtual optokinetic stimulation
These patients are only examined with the physical stimulation to avoid excessive symptom burden.
Diagnostic Test: Postural Response upon physical optokinetic stimulation
These patients are only examined with the virtual stimulation to avoid excessive symptom burden.
Diagnostic Test: Postural Response upon virtual optokinetic stimulation
The physical optokinetic stimulation consists of rotating stimulation in either direction using a physical disc (de Vestel, et al., 2022; Guerraz et al., 2001; van Ombergen et al., 2016). The assessment is conducted in complete dark, unless the fluorescent dots (approx. 11% covered of the disc area.). The disc has a diameter of 1 m. Stimulation time per trial will be 30 s.
The virtual optokinetic stimulation is implemented in virtual reality goggles (Meta Quest 3, Meta Platforms, Menlo Park, CA, USA) applying oscillating and rotating stimulation in frontal and vertical axis with coherent or incoherent stimuli. The assessment in the virtual environment will be as similar as possible compared the physical stimulation. Hence, the virtual environment simulation complete dark, unless the fluorescent dots (approx. 15% covered of the disc area.). In addition to the rotating condition, the virtual dots are able to oscillate on the horizontal or vertical axis to create a more sensitive evaluation method than the physical one (Laurens et al., 2011). Stimulation time per trial will be 30 s.
Sensitivity of Postural Response to Optokinetic Stimulation
To identify visually induced dizziness through the balance assessment, cutoff values based on calculated balance parameters will be evaluated to differentiate balance responses between concussed patients, non-concussed dizzy patients, and healthy controls. The reference will be the VID assessment performed during the clinical examination. Measurement Tool: * 6D sensor system (accelerometer and gyroscope) placed on the lower back and head. * acceleration in m/s\^2 * gyroscope in deg/s) Unit of Measure: Calculations on the balance responses from each measuring site and sensor type (accelerometer, gyroscope) include temporal and spectral parameters such as: * 95% area of motion (m\^2/s\^4, deg\^2/s\^2) * RMS, SD, Mean (m/s\^2, deg/s) * Power Spectral Density (PSD) between 0.1-2 Hz ((m\^2/s\^4)/Hz, (deg\^2 /s\^2)/Hz) * Power Spectral Density (PSD) at stimulation frequency of 1/3 Hz((m\^2/s\^4)/Hz, (deg\^2 /s\^2)/Hz) Comparison: * Balance parameters among the investigated groups
Time frame: Time Point 1: During the first intervention, measurement on a single day. Time Point 2: 15 minutes after the first intervention, measurement on a single day
Identification of Different Postural Characteristics Response to Optokinetic Stimulation
It is hypothesized that patients with different diagnoses will exhibit distinct postural response patterns, which can be quantified and categorised. Based on the diagnosis, specific characteristics from the determined parameters shall be analysed. Measurement Tool: * 6D sensor system (accelerometer and gyroscope) placed on the lower back and head. * acceleration in m/s\^2 * gyroscope in deg/s) Unit of Measure: Calculations on the balance responses from each measuring site and sensor type (accelerometer, gyroscope) include temporal and spectral parameters such as: * 95% area of motion (m\^2/s\^4, deg\^2/s\^2) * RMS, SD, Mean (m/s\^2, deg/s) * Power Spectral Density (PSD) between 0.1-2 Hz ((m\^2/s\^4)/Hz, (deg\^2 /s\^2)/Hz) * Power Spectral Density (PSD) at stimulation frequency of 1/3 Hz((m\^2/s\^4)/Hz, (deg\^2 /s\^2)/Hz) Comparison: * Differences and rates of change in determined parameters are clustered across these groups
Time frame: Time Point 1: During the first intervention, measurement on a single day. Time Point 2: 15 minutes after the first intervention, measurement on a single day
Severity of Visually Induced Dizziness
The balance assessment outcome shall be used to categorise the severity of visually induced dizziness based on calculated balance parameters. Measurement Tool: * 6D sensor system (accelerometer and gyroscope) placed on the lower back and head. * acceleration in m/s\^2 * gyroscope in deg/s) Unit of Measure: Calculations on the balance responses from each measuring site and sensor type (accelerometer, gyroscope) include temporal and spectral parameters such as: * 95% area of motion (m\^2/s\^4, deg\^2/s\^2) * RMS, SD, Mean (m/s\^2, deg/s) * Power Spectral Density (PSD) between 0.1-2 Hz ((m\^2/s\^4)/Hz, (deg\^2 /s\^2)/Hz) * Power Spectral Density (PSD) at stimulation frequency of 1/3 Hz((m\^2/s\^4)/Hz, (deg\^2 /s\^2)/Hz) Comparison: * Balance parameters will be classified into clusters, such as normal, borderline, and abnormal balance behaviour.
Time frame: Time Point 1: During the first intervention, measurement on a single day. Time Point 2: 15 minutes after the first intervention, measurement on a single day
Comparison of virtual and physical optokinetic stimulation in healthy subjects
Balance responses will be compared between the two arms of healthy subjects who complete both types of balance assessments (virtual and physical optokinetic stimulation). Measurement Tool: * 6D sensor system (accelerometer and gyroscope) placed on the lower back and head. * acceleration in m/s\^2 * gyroscope in deg/s) Unit of Measure: Calculations on the balance responses from each measuring site and sensor type (accelerometer, gyroscope) include temporal and spectral parameters such as: * 95% area of motion (m\^2/s\^4, deg\^2/s\^2) * RMS, SD, Mean (m/s\^2, deg/s) * Power Spectral Density (PSD) between 0.1-2 Hz ((m\^2/s\^4)/Hz, (deg\^2 /s\^2)/Hz) * Power Spectral Density (PSD) at stimulation frequency of 1/3 Hz((m\^2/s\^4)/Hz, (deg\^2 /s\^2)/Hz) Comparison: * Balance parameters among healthy controls.
Time frame: Time Point 1: During the first intervention, measurement on a single day. Time Point 2: 15 minutes after the first intervention, measurement on a single day
Plan to share: Yes — Data from the CRF, raw values from the balance measurements, and calculated balance parameter will be shared IPD: Diagnosis related to VID: Group assignment Informed Consent Anthropometric data (weight, height) Age Questionnaire's data: DHI, VVAS, SVQ, SSQ Symptom burden during balance assessment Completion of assessment Balance raw data Calculated balance parameters
Time frame: 01.01.2026 (before publication) - 01.01.2030 (3 years after publication)
Access criteria: Associates from the University of Zurich: Full access to anonymised IPD Access to IPD and supporting information will be granted to other researchers and reviews who first establish contact with the Sponsor of University of Zurich and provide a detailed description of their research plan. Upon approval, data will be shared through a secure access system in compliance with institutional and ethical guidelines.
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