Clinical trial NCT04649268: Comparison of Optokinetic Stimulation Treatments
Official title: The Effect of Virtual Reality and DVD Optokinetic Stimulation Exposure on Visual Induced Dizziness Symptoms in Persons With a Vestibular Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Vestibular Disorder
Keywords: optokinetic stimulation
visually induced dizziness
vestibular
virtual reality
Oculus Quest headset
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2020-12-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a pilot study and 24 participants will be randomised into one of two rehabilitation groups incorporating OKS treatment with Optokinetic DVD (Group A) or VR headset (e.g. Oculus Quest headset) (Group B).
Primary purpose: TREATMENT

Brief summary: Persons with a vestibular (e.g. inner ear) disorder often report visual induced dizziness (ViD) symptom (i.e. postural and/or gait instability, dizziness, disorientation) provocation or exacerbation in environments with busy or conflicting visual motion including crowds and supermarkets. ViD is frequently associated with high disability levels, prolonged illness and poorer clinical outcome. Thus, effective treatment is a priority. Vestibular rehabilitation incorporating structured exposure to Optokinetic Stimulation (OKS) (e.g. a form of computer based intervention that involves the observation of moving visual targets to encourage visual scanning) significantly improves ViD symptoms with similar improvement noted for both 'low-tech' OKS provided via a DVD or a 'high-tech', expensive, full-field stimulus. No studies have investigated if 'lower-tech', cheaper Virtual Reality (VR) systems may be beneficial in treating ViD symptoms and whether these VR systems are more effective than an OKS DVD. The first aim of this work is to compare the effect of an OKS DVD vs "lower-tech" VR system on ViD symptoms in persons with a chronic peripheral vestibular disorder aged 18-50 years old. This study may help to identify more optimal treatment strategies in persons with a vestibular disorder.

Detailed description: Background People with ViD report symptom (i.e. postural and/or gait instability, dizziness, disorientation) provocation or exacerbation in environments with busy or conflicting visual motion including crowds, supermarkets and scrolling computer screens. Visual dependence and impaired sensory re-weighting have been identified as main contributors to balance problems in persons with vestibular disorders and are frequently associated with high disability levels, prolonged illness, and poorer clinical outcome in adults with vestibular dysfunction including vestibular migraine.

Evidence suggests that ViD symptoms respond well to rehabilitation incorporating structured exposure to OKS. Treatment with gradual, progressive exposure to OKS in combination with static and dynamic functional balance exercises has been shown to improve visual dependency, functional balance and gait as well as symptoms provoked or exacerbated in busy visual environments, such as crowds, in persons with a vestibular disorder. It is believed that improvements in ViD following treatment with OKS is due to sensory-reweighting which is the ability of CNS to adapt its relative reliance on a specific sensory modality for purposes of orientation depending on environmental conditions, task demands and/ or pathology.

During neuroimaging studies, exposure to visual OKS, in the absence of vestibular stimulation, results in consistent activation of cortical regions involved in the control of visual motion processing and eye movement, and deactivation of parieto-insular vestibular cortices indicating a reciprocally inhibitory visual-vestibular interaction. Similarly, stimulation of multisensory vestibular cortex areas results in bilateral deactivation in visual and somatosensory cortex areas. These interactions may have a functional significance and indicate a sensor re-weighting process with greater weight given to the more reliable input thus suppressing the possible mismatch between contrasting sensory information. It is believed that the recurring exposure to conflicting visual input promotes reduced visual reliance and facilitates a more effective use of vestibule-proprioceptive cues through sensory re-weighting.

However, the exact mechanisms involved in sensory re-weighting in persons with visual induced dizziness remain poorly understood.

Finally, previous work has demonstrated that low tech OKS provided via a DVD produces the same level of improvement as a more expensive, full field stimulus. Findings for the effect of virtual reality (VR) on ViD are inconclusive. Furthermore, to date only VR provided via an immersive projection theatre, often referred to as a CAVE has been used to investigate its effect on ViD. This equipment is very expensive and available only within a specialist centre. No studies have investigated if 'lower-tech' VR such as VR headset and specifically, Oculus Quest headset, may be beneficial in treatment of ViD at a much lower cost. The use of 'lower-tech' OKS equipment is promising, more widely available to clinical practice and safe to be used at home by the patients for rehabilitation purposes. However, it is not known if one type of 'lower-tech' equipment may provide greater benefit compared to another.

Purpose of the study The proposed pilot study is a non-commercial-PhD student project. The purpose of this investigation is to compare two types of OKS based VRT for the improvement of ViD in persons with a chronic vestibular disorder.

Objectives/Aims of the study The primary objective of this study is to compare the effect of two types of optokinetic stimulation (OKS) based vestibular rehabilitation (VRT) programmes on Situational Characteristics Questionnaire (SCQ) scores in persons with a chronic vestibular disorder who experience ViD aged 18-50 years old.

The secondary objectives are to compare the pre-post treatment effect of two types of OKS based VRT on subjective dizziness, psychological state, balance confidence and objective gait, balance and ViD symptoms.

Primary Hypothesis Both types of OKS will provide significant improvement on SCQ scores, but improvement with VR will be greater.

Secondary Hypothesis VRT with VR Oculus Quest headset may provide greater treatment outcome on gait and balance control, participant's subjective symptoms, psychological state and cognitive function.

Eligibility criteria: Inclusion Criteria:

1. clinical diagnosis of a peripheral vestibular disorder;
2. chronic dizziness and/or unsteadiness;
3. 18 to 50 years old;
4. no previous rehabilitation or previous VRT programme completed with partial/no improvement;
5. willing to participate and to comply with the proposed training and testing regime; and
6. current SCQ score \>0,7/4. Patient diagnosis will be based on clinical history and/or neuro-otological findings, according to published normative data and limits. Persons with Benign Paroxysmal Positional Vertigo (BPPV) will be included, in the study, due to the persistence of imbalance and dizziness after BPPV resolution. The diagnosis of migraine will be made according to the International Headache Society Criteria for Migraine as well as Neuhauser Criteria for VM.

Exclusion Criteria:

Persons with:

1. central nervous system involvement, excluding migraine. However, patients with severe migraine (\> 3 migrainous headaches monthly) will be excluded.
2. fluctuating symptoms, for example, active Ménière disease;
3. acute orthopaedic disorders influencing balance control and gait;
4. a score of \< 23/30 on the MoCA;
5. a score of \>15/21 on the HADS for the depression component indicating significant depression symptoms;
6. inability to attend sessions;
7. diagnosis of neurological disorder;
8. currently attending or has completed a rehabilitation programme targeting balance and/or dizziness in the past year or is currently part of a clinical trial testing a medicinal product. These factors may skew both the assessment scores and treatment outcome and for this reason they are listed as exclusion criteria; and
9. lack of a good grasp of written/spoken English will be excluded. The latter due to the need to complete multiple questionnaires and the lack of funding for interpreters.

Primary outcomes:
measure: Situational Characteristics Questionnaire (SCQ)
timeFrame: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).
Secondary outcomes:
measure: Functional Gait Assessment (FGA)
timeFrame: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).
measure: Rod and Disc Test
timeFrame: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).
measure: LEGSys™ and Balansens (Biosensics, MA, USA)
timeFrame: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).
measure: Montreal Cognitive Assessment (MoCA) Tool
timeFrame: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).
measure: Vertigo Symptom Scale (VSS)
timeFrame: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
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