Comparison of Optokinetic Stimulation Treatments

Not Applicable

• Conditions: Peripheral Vestibular Disorder
• Interventions: Other: Group A; Device: Group B

• Registration Number: NCT04649268
• Lead Sponsor: King's College London

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.

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-30
• Study First Posted: 2020-12-02
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01
• Study Start: 2021-12-28
• Primary Completion: 2021-12-28
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optokinetic stimulation treatment with visual motion DVDs	Group A	Customised vestibular rehabilitation programme which includes optokinetic stimulation treatment with visual motion DVDs
Optokinetic stimulation treatment with Virtual Reality	Group B	Customised vestibular rehabilitation programme which includes optokinetic stimulation treatment with Virtual Reality environments delivered with headset (e.g. Oculus Quest headset)

Primary Outcome Measures

Name	Time	Method
Situational Characteristics Questionnaire (SCQ)	Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).	This is the primary outcome. The Situational Characteristics Questionnaire (SCQ) -shortened version measures how frequently symptoms are provoked or exacerbated in environments with visual vestibular mismatch or intense visual motion (e.g. travelling on escalators, crowds, scrolling computer screens). Scores ≥0.7/4 indicate visual induced dizziness symptoms.

Secondary Outcome Measures

Name	Time	Method
Cambridge Neuropsychological Test Automated Battery (CANTAB)	Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).	Cambridge Neuropsychological Test Automated Battery (CANTAB) is a semi-automated computer program that utilizes a touch screen technology and press pad, to assess neurocognitive function. The CANTAB core cognition battery is a validated cognitive assessment system for assessing multiple components of cognitive function, including attention, visual memory, spatial memory, executive function and reaction time.; Each subject will be comfortably seated at approximate distance of 0.5m away from the screen pad monitor and will be asked to complete the CANTAB tests after instructions have been provided. The tests that will be included are Rapid Visual Information Processing (RVP), Paired Associates Learning (PAL), Spatial Working Memory (SWM), Reaction Time (RTI), Delayed Matching to Sample (DMS), Motor Screening Task (MOT), Spatial Span (SSP) and Multitasking Test (MTT). The test order will be different for each participant.
Vertigo Symptom Scale (VSS)	Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).	The VSS is used to assess the frequency and severity of common vestibular (VSS-V; e.g. vertigo, imbalance) and autonomic/somatic (VSS-A; e.g. heart pounding, heavy feeling in the arms or legs) symptoms. Normalised scores range from 0-4, with higher scores indicating a higher (i.e. worse) level of symptoms.
Functional Gait Assessment (FGA)	Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).	It is a 10-item test that assesses performance on complex gait tasks (i.e. walking with head turns, stepping over an obstacle or stopping and turning). The highest score is 30 and greater outcomes are indicative of better performance. The FGA has been validated in healthy people, older adults with a history of falls and balance impairments, and people with a vestibular disorder. The minimal detectable change for the FGA is reported to be 6 points in persons with balance and vestibular disorders. Scores ≤22/30 identify fall risk and are predictable of falls in community-living older persons within 6 months.
LEGSys™ and Balansens (Biosensics, MA, USA)	Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).	LEGSys™and Balansens (Biosensics, MA, USA) which will be used to assess gait and balance respectively, are a validated wearable technology that uses five inertial sensors (triaxial accelerometer and gyroscope) attached to both shins above ankles, thighs above knees, and lower back close to sacrum.; Balance will be measured in four trials of 15 seconds, (1) with eyes open on a stable surface with no visual target specified, (2) with eyes closed on a stable surface, (3) with eyes closed on an incline surface and (4) with eyes closed on a foam surface. Gait assessment will be conducted as participants will walk a distance with a minimum of 25 steps under four conditions: (1) habitual over ground normal walk (preferred speed), (2) fast over ground, (3) habitual over ground normal walk with horizontal head turns and (4) habitual over ground normal walk with vertical head turns.
Montreal Cognitive Assessment (MoCA) Tool	Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).	The Montreal Cognitive Assessment (MoCA) Tool is a rapid screening tool for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive function, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. It has been recommended that a cut-off scores of 23/30 be used to identify multi-domain cognitive impairment. This is the first test that will be completed. Persons with scores \<23/30 will not be included in the study and will be referred back to the clinical team for further assessment and onward referral as required.
Rod and Disc Test	Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).	Visual dependence is measured using the Rod and Disk Test on a laptop computer. Participants will be seated in front of a computer in a darkened room with their head held against a viewing cone that blocks extraneous visual orientation cues. The diameter of the cone at the participants' eyes will be 15cm with a depth of field of 30 cm, subtending a viewing angle of 39 degrees. The visual stimulus consists of a luminous white 6cm rod on a black background. The rod rotated 360 degrees in either direction about its midpoint in the central 11 degrees of the visual filed. Outside of this central zone, the viewing screen is filled with a collage of 220 off-white dots, each 8mm (1.5 degrees of visual field) in diameter, randomly distributed on a black background. Participants control the orientation of the rod with a roller mouse. They are instructed to align the rod to their perceived vertical (the subjective visual vertical) under three conditions.
Hospital Anxiety and Depression Scale (HADS)	Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).	The HADS, a 14-item scale which assesses non-somatic anxiety (HAD-A) and depression (HAD-D) symptoms, will also be completed. Scores range from 0-21 for each subscale with a score ≥8 proposed for the identification of caseness, for both depression and anxiety.

Trial Locations

Locations (1)

King's College London; 🇬🇧 London, United Kingdom