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

NCT06893029 | Recruiting

• 1 other identifier: 2024-00956
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

Dizziness; Concussion (Diagnosis); Traumatic Brain Injury; Balance Assessment

Keywords

Visually induced dizziness

Outcome Measures

Primary Outcomes (1)

• 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 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 (2)

• Identification of Different Postural Characteristics Response to Optokinetic Stimulation

  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 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 (1)

• Comparison of virtual and physical optokinetic stimulation in healthy subjects

  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

Study Arms (4)

Healthy Subjects (Physical / Virtual)

ACTIVE COMPARATOR

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

Healthy Subjects (Virtual / Physical)

ACTIVE COMPARATOR

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

Patients (Physical)

EXPERIMENTAL

These patients are only examined with the physical stimulation to avoid excessive symptom burden.

Diagnostic Test: Postural Response upon physical optokinetic stimulation

Patients (Virtual)

EXPERIMENTAL

These patients are only examined with the virtual stimulation to avoid excessive symptom burden.

Diagnostic Test: Postural Response upon virtual optokinetic stimulation

Interventions

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.

Healthy Subjects (Physical / Virtual); Healthy Subjects (Virtual / Physical); Patients (Physical)

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.

Healthy Subjects (Physical / Virtual); Healthy Subjects (Virtual / Physical); Patients (Virtual)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dominik Straumann: lead
• University Hospital, Zürich: collaborator
• BrainCare Medical Group: collaborator

Study Sites (2)

BrainCare Medical Group

Zurich, Canton of Zurich, 8002, Switzerland

RECRUITING

University Hospital Zurich, Department of Neurology

Zurich, Canton of Zurich, 8006, Switzerland

RECRUITING

Related Publications (11)

• 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.

  PMID: 19775892 BACKGROUND

• 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.

  PMID: 22113702 BACKGROUND

• 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.

  PMID: 24057827 BACKGROUND

• 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.

  PMID: 26231270 BACKGROUND

• 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.

  PMID: 30855306 BACKGROUND

• 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.

  PMID: 27128970 BACKGROUND

• 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.

  PMID: 17538212 BACKGROUND

• 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.

  PMID: 37316210 BACKGROUND

• 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.

  PMID: 11459755 BACKGROUND

• 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.

  PMID: 35685740 BACKGROUND

• 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.

  PMID: 21558640 BACKGROUND

MeSH Terms

Conditions

Dizziness; Brain Concussion; Disease; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Pathologic Processes

Central Study Contacts

Dominik Straumann, Prof. Dr. med.

CONTACT

+41 44 255 55 64; Dominik.Straumann@uzh.ch

Samuel Meyer, MSc

CONTACT

Samuel.Meyer3@uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: 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).

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 25, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

CH (2)