Clinical trial NCT06893029: Dizziness Due to Visual Stimuli in Patients With Concussion and Other Causes of Dizziness: Examination of Balance Behaviour
Official title: Visually Induced Dizziness in Concussed and Non-Concussed Dizzy Patients: Identifying the Pathophysiology of Postural Control Upon Optokinetic Stimuli
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dizziness
Concussion (Diagnosis)
Traumatic Brain Injury
Balance Assessment
Keywords: Visually induced dizziness
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University Hospital, Zürich
name: BrainCare Medical Group
First posted: 2025-03-25
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The project is organised in 4 arms, as healthy subjects and patients will be examined. Optokinetic stimulation will be applied to eighter by a physical disc or a head mounted device using virtual application. Healthy subjects will conduct a physical and a virtual balance assessment with visual stimulation, in a cross-over design. Patients will only conduct one type of balance assessment, physical or virtual, to prevent symptom exacerbation. This limitation for dizzy patients is based on the experience of leading clinicians from the vertigo center and on former research projects in the field of VID (de Vestel, et al., 2022; Guerraz et al., 2001; van Ombergen et al., 2016).
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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:

  1. Neurological conditions (e.g., migraine)
  2. Orthopaedic conditions (e.g., lower extremity injury)
  3. Infectious diseases
  4. 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

Primary outcomes:
measure: Sensitivity of Postural Response to Optokinetic Stimulation
timeFrame: 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
Secondary outcomes:
measure: Identification of Different Postural Characteristics Response to Optokinetic Stimulation
timeFrame: 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
measure: Severity of Visually Induced Dizziness
timeFrame: 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
Other outcomes:
measure: Comparison of virtual and physical optokinetic stimulation in healthy subjects
timeFrame: 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
Locations:
city: Zurich
country: Switzerland
facility: BrainCare Medical Group
state: ZH
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Department of Neurology
state: ZH
Study officials:
References:
citation: Laurens J, Awai L, Bockisch CJ, Hegemann S, van Hedel HJ, Dietz V, Straumann D. Visual contribution to postural stability: Interaction between target fixation or tracking and static or dynamic large-field stimulus. Gait Posture. 2010 Jan;31(1):37-41. doi: 10.1016/j.gaitpost.2009.08.241. Epub 2009 Sep 22.
citation: Agarwal K, Bronstein AM, Faldon ME, Mandala M, Murray K, Silove Y. Visual dependence and BPPV. J Neurol. 2012 Jun;259(6):1117-24. doi: 10.1007/s00415-011-6311-7. Epub 2011 Nov 24.
citation: Fife TD, Giza C. Posttraumatic vertigo and dizziness. Semin Neurol. 2013 Jul;33(3):238-43. doi: 10.1055/s-0033-1354599. Epub 2013 Sep 21.
citation: Bisdorff AR, Staab JP, Newman-Toker DE. Overview of the International Classification of Vestibular Disorders. Neurol Clin. 2015 Aug;33(3):541-50, vii. doi: 10.1016/j.ncl.2015.04.010.
citation: Kontos AP, Sufrinko A, Sandel N, Emami K, Collins MW. Sport-related Concussion Clinical Profiles: Clinical Characteristics, Targeted Treatments, and Preliminary Evidence. Curr Sports Med Rep. 2019 Mar;18(3):82-92. doi: 10.1249/JSR.0000000000000573.
citation: Van Ombergen A, Lubeck AJ, Van Rompaey V, Maes LK, Stins JF, Van de Heyning PH, Wuyts FL, Bos JE. The Effect of Optokinetic Stimulation on Perceptual and Postural Symptoms in Visual Vestibular Mismatch Patients. PLoS One. 2016 Apr 29;11(4):e0154528. doi: 10.1371/journal.pone.0154528. eCollection 2016.
citation: Pavlou M, Davies RA, Bronstein AM. The assessment of increased sensitivity to visual stimuli in patients with chronic dizziness. J Vestib Res. 2006;16(4-5):223-31.
citation: Patricios JS, Schneider KJ, Dvorak J, Ahmed OH, Blauwet C, Cantu RC, Davis GA, Echemendia RJ, Makdissi M, McNamee M, Broglio S, Emery CA, Feddermann-Demont N, Fuller GW, Giza CC, Guskiewicz KM, Hainline B, Iverson GL, Kutcher JS, Leddy JJ, Maddocks D, Manley G, McCrea M, Purcell LK, Putukian M, Sato H, Tuominen MP, Turner M, Yeates KO, Herring SA, Meeuwisse W. Consensus statement on concussion in sport: the 6th International Conference on Concussion in Sport-Amsterdam, October 2022. Br J Sports Med. 2023 Jun;57(11):695-711. doi: 10.1136/bjsports-2023-106898.
citation: Guerraz M, Yardley L, Bertholon P, Pollak L, Rudge P, Gresty MA, Bronstein AM. Visual vertigo: symptom assessment, spatial orientation and postural control. Brain. 2001 Aug;124(Pt 8):1646-56. doi: 10.1093/brain/124.8.1646.
citation: De Vestel C, De Hertogh W, Van Rompaey V, Vereeck L. Comparison of Clinical Balance and Visual Dependence Tests in Patients With Chronic Dizziness With and Without Persistent Postural-Perceptual Dizziness: A Cross-Sectional Study. Front Neurol. 2022 May 24;13:880714. doi: 10.3389/fneur.2022.880714. eCollection 2022.
citation: Dannenbaum E, Chilingaryan G, Fung J. Visual vertigo analogue scale: an assessment questionnaire for visual vertigo. J Vestib Res. 2011;21(3):153-9. doi: 10.3233/VES-2011-0412.