- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06893029
Dizziness Due to Visual Stimuli in Patients With Concussion and Other Causes of Dizziness: Examination of Balance Behaviour
Visually Induced Dizziness in Concussed and Non-Concussed Dizzy Patients: Identifying the Pathophysiology of Postural Control Upon Optokinetic Stimuli
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.
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dominik Straumann, Prof. Dr. med.
- Phone Number: +41 44 255 55 64
- Email: Dominik.Straumann@uzh.ch
Study Contact Backup
- Name: Samuel Meyer, MSc
- Email: Samuel.Meyer3@uzh.ch
Study Locations
-
-
Canton of Zurich
-
Zurich, Canton of Zurich, Switzerland, 8002
- Recruiting
- BrainCare Medical Group
-
Contact:
- Nina Feddermann, Dr. med.
- Phone Number: +41 44 500 41 50
- Email: nina.feddermann@braincare.swiss
-
Contact:
- Phone Number: +41 44 500 41 50
- Email: info@braincare.swiss
-
Principal Investigator:
- Nina Feddermann, Dr. med.
-
Zurich, Canton of Zurich, Switzerland, 8006
- Recruiting
- University Hospital Zurich, Department of Neurology
-
Contact:
- Dominik Straumann, Prof. Dr. med.
- Phone Number: +41 44 255 55 64
- Email: Dominik.Straumann@usz.ch
-
Contact:
- Samuel Meyer, MSc
- Phone Number: +41 43 253 73 17
- Email: Samuel.Meyer@usz.ch
-
Principal Investigator:
- Dominik Straumann, Prof. Dr. med.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Healthy Subjects (Physical / Virtual)
Cross-over design for healthy subjects, physical optokinetic stimulation in advance to 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.
|
|
Active Comparator: Healthy Subjects (Virtual / Physical)
Cross-over design for healthy subjects, virtual optokinetic stimulation in advance to physical 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.
|
|
Experimental: Patients (Physical)
These patients are only examined with the physical stimulation to avoid excessive symptom burden.
|
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.
|
|
Experimental: Patients (Virtual)
These patients are only examined with the virtual stimulation to avoid excessive symptom burden.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
Unit of Measure: Calculations on the balance responses from each measuring site and sensor type (accelerometer, gyroscope) include temporal and spectral parameters such as:
Comparison:
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
Unit of Measure: Calculations on the balance responses from each measuring site and sensor type (accelerometer, gyroscope) include temporal and spectral parameters such as:
Comparison:
|
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
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:
Unit of Measure: Calculations on the balance responses from each measuring site and sensor type (accelerometer, gyroscope) include temporal and spectral parameters such as:
Comparison:
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
Unit of Measure: Calculations on the balance responses from each measuring site and sensor type (accelerometer, gyroscope) include temporal and spectral parameters such as:
Comparison:
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Pathologic Processes
- Sensation Disorders
- Craniocerebral Trauma
- Trauma, Nervous System
- Head Injuries, Closed
- Wounds, Nonpenetrating
- Brain Injuries
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Brain Injuries, Traumatic
- Disease
- Brain Concussion
- Dizziness
Other Study ID Numbers
- 2024-00956
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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