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NCT Number: NCT06893029

Dizziness Due to Visual Stimuli in Patients With Concussion and Other Causes of Dizziness: Examination of Balance Behaviour

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 60 years
  • Binocular vision
  • Recent concussion/mTBI within 4 weeks to 18 months post-injury for concussed patients
  • Diagnosis related to dizziness or VID within 4 weeks to 18 months for non-concussed dizzy patients (including vestibular migraine)
  • Signed ICF for included participants or signed general consent for retrospectively included patients if an ICF cannot be obtained.

Exclusion criteria

  • BMI greater than 30
  • Acute vestibular syndrome lasting at least 24 hours
  • Severe non-correctable visual impairment
  • Balance issues not dizziness-related, including:
  • Neurological conditions (e.g., migraine)
  • Orthopaedic conditions (e.g., lower extremity injury)
  • Infectious diseases
  • Other medical contexts
  • Dizziness attributed to prescribed drugs, substance abuse, or mental disorders
  • Cognitive impairments compromising task comprehension
  • Preceding history of traumatic brain injury in the last 12 months
  • History of severe traumatic brain injury with persisting impairments
  • Other potentially confounding problems (e.g., psychiatric disease)
  • Frequent episodes of rotatory vertigo

Treatment and study plan

Postural Response upon physical optokinetic stimulation

Diagnostic Test

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.

Postural Response upon virtual optokinetic stimulation

Diagnostic Test

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.

Primary outcomes

  1. Sensitivity of Postural Response to Optokinetic Stimulation

    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

    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

Secondary outcomes

  1. Identification of Different Postural Characteristics Response to Optokinetic Stimulation

    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

    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
  2. Severity of Visually Induced Dizziness

    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

    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.

Other outcomes

  1. Comparison of virtual and physical optokinetic stimulation in healthy subjects

    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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dominik Straumann, Prof. Dr. med.

CONTACT

[email protected]

+41 44 255 55 64

Samuel Meyer, MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Dominik Straumann

Other

Collaborators

  • BrainCare Medical Group
  • University Hospital, Zürich

Registry information

Official study title

Visually Induced Dizziness in Concussed and Non-Concussed Dizzy Patients: Identifying the Pathophysiology of Postural Control Upon Optokinetic Stimuli

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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