Peripheral Vestibular DisorderNCT04649268

Comparison of Optokinetic Stimulation Treatments

A study testing Group B and Group A in people with Peripheral Vestibular Disorder, run by King's College London at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Peripheral Vestibular Disorder
What is being tested?: Group B and Group A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited Kingdom
Study dates: 28 Dec 2021to 30 Jun 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

clinical diagnosis of a peripheral vestibular disorder;
chronic dizziness and/or unsteadiness;
18 to 50 years old;
no previous rehabilitation or previous VRT programme completed with partial/no improvement;
willing to participate and to comply with the proposed training and testing regime; and
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.

Who cannot join

Persons with:
central nervous system involvement, excluding migraine. However, patients with severe migraine (> 3 migrainous headaches monthly) will be excluded.
fluctuating symptoms, for example, active Ménière disease;
acute orthopaedic disorders influencing balance control and gait;
a score of < 23/30 on the MoCA;
a score of >15/21 on the HADS for the depression component indicating significant depression symptoms;

Show all 10Show fewer

inability to attend sessions;
diagnosis of neurological disorder;
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
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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

King's College London
London, SE1 1UL

Other trials in United Kingdom

About this study

Official title: The Effect of Virtual Reality and DVD Optokinetic Stimulation Exposure on Visual Induced Dizziness Symptoms in Persons With a Vestibular Disorder

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.

Read the 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.

Conditions: Peripheral Vestibular Disorder
Being tested: Group B, Group A
Keywords: optokinetic stimulation, visually induced dizziness, vestibular, virtual reality, Oculus Quest headset

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Group BDevice
Also called C2CARE Class I medical device: virtual environments, C2CARE PSY: C2 Physio 2019.2, Optokinetic stimulation treatment with Virtual Reality
The C2 CARE C2 Physio 2019.2 has been developed for physiotherapy rehabilitation purposes including vestibular disorders. Virtual reality environments will be provided via the VR Oculus Quest headset as part of the OKS exposure incorporated within a customised VRT programme. Participants will attend 45 minute individualised supervised sessions once weekly for 8 weeks. Participants in this rehabilitation group will also have a home-based exercise programme to practise on days not attending clinic. The home-based programme will incorporate customised VRT exercises with exposure to VR environments using the VR Oculus Quest headset.
Group AOther
Also called Optokinetic stimulation treatment with visual motion DVDs
Optokinetic stimulation treatment delivered through visual motion DVDs. Individualised 45 minute supervised sessions will occur for this group also once weekly for 8 weeks together with a home-based customised VRT programme incorporation the DVD to practise on days not attending clinic. Participants will have to use the OKS DVD for their exercises at home daily for 8 weeks as part of the prescribed home exercise programme.

Study groups in NCT04649268
Study group	Role	What they receive
Optokinetic stimulation treatment with visual motion DVDs	Active comparator	Customised vestibular rehabilitation programme which includes optokinetic stimulation treatment with visual motion DVDs Receives: Other: Group A
Optokinetic stimulation treatment with Virtual Reality	Experimental	Customised vestibular rehabilitation programme which includes optokinetic stimulation treatment with Virtual Reality environments delivered with headset (e.g. Oculus Quest headset) Receives: Device: Group B

What is being measured

The primary outcome is the main question the study is designed to answer.

Situational Characteristics Questionnaire (SCQ)
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.
Measured: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).

Secondary outcomes (7)

Functional Gait Assessment (FGA)
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.
Measured: 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)
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.
Measured: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).
Rod and Disc Test
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.
Measured: 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)
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.
Measured: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).
Montreal Cognitive Assessment (MoCA) Tool
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.
Measured: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).
Hospital Anxiety and Depression Scale (HADS)
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.
Measured: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).
Vertigo Symptom Scale (VSS)
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.
Measured: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Dec 202130 Jun 2022

First posted2 Dec 2020
Study start28 Dec 2021 (estimated)
Primary completion28 Dec 2021 (estimated)
Study completion30 Jun 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (48)Papers the sponsor has linked to this study.
Other trials for Peripheral Vestibular DisorderStudies of the same condition, open and under way.
More trials run by King's College LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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).
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04649268
Sponsor's protocol ID: REC Reference: 20/LO/1244
Status last verified: Nov 2020
First submitted: 13 Nov 2020
Last updated: 1 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Pavlou M, Lingeswaran A, Davies RA, Gresty MA, Bronstein AM. Simulator based rehabilitation in refractory dizziness. J Neurol. 2004 Aug;251(8):983-95. doi: 10.1007/s00415-004-0476-2.
PubMed 15316804
Bisdorff A, Von Brevern M, Lempert T, Newman-Toker DE. Classification of vestibular symptoms: towards an international classification of vestibular disorders. J Vestib Res. 2009;19(1-2):1-13. doi: 10.3233/VES-2009-0343. No abstract available.
PubMed 19893191
Indovina I, Riccelli R, Chiarella G, Petrolo C, Augimeri A, Giofre L, Lacquaniti F, Staab JP, Passamonti L. Role of the Insula and Vestibular System in Patients with Chronic Subjective Dizziness: An fMRI Study Using Sound-Evoked Vestibular Stimulation. Front Behav Neurosci. 2015 Dec 9;9:334. doi: 10.3389/fnbeh.2015.00334. eCollection 2015.
PubMed 26696853
Lempert T. Vestibular migraine. Semin Neurol. 2013 Jul;33(3):212-8. doi: 10.1055/s-0033-1354596. Epub 2013 Sep 21.
PubMed 24057824
Pavlou M, Bronstein AM, Davies RA. Randomized trial of supervised versus unsupervised optokinetic exercise in persons with peripheral vestibular disorders. Neurorehabil Neural Repair. 2013 Mar-Apr;27(3):208-18. doi: 10.1177/1545968312461715. Epub 2012 Oct 16.
PubMed 23077146
Pavlou M, Kanegaonkar RG, Swapp D, Bamiou DE, Slater M, Luxon LM. The effect of virtual reality on visual vertigo symptoms in patients with peripheral vestibular dysfunction: a pilot study. J Vestib Res. 2012;22(5-6):273-81. doi: 10.3233/VES-120462.
PubMed 23302708
Cawthorne TE. The physiological basis for head exercises. J Chart Soc Physiother. 1944; 30:106-107.
Morozetti PG, Gananca CF, Chiari BM. Comparison of different protocols for vestibular rehabilitation in patients with peripheral vestibular disorders. J Soc Bras Fonoaudiol. 2011 Mar;23(1):44-50. doi: 10.1590/s2179-64912011000100011. English, Portuguese.
PubMed 21552732
Whitney SL, Wrisley DM, Brown KE, Furman JM. Physical therapy for migraine-related vestibulopathy and vestibular dysfunction with history of migraine. Laryngoscope. 2000 Sep;110(9):1528-34. doi: 10.1097/00005537-200009000-00022.
PubMed 10983955
Dieterich M, Bense S, Stephan T, Yousry TA, Brandt T. fMRI signal increases and decreases in cortical areas during small-field optokinetic stimulation and central fixation. Exp Brain Res. 2003 Jan;148(1):117-27. doi: 10.1007/s00221-002-1267-6. Epub 2002 Nov 13.
PubMed 12478402
Kleinschmidt A, Thilo KV, Buchel C, Gresty MA, Bronstein AM, Frackowiak RS. Neural correlates of visual-motion perception as object- or self-motion. Neuroimage. 2002 Aug;16(4):873-82. doi: 10.1006/nimg.2002.1181.
PubMed 12202076
Brandt T, Bartenstein P, Janek A, Dieterich M. Reciprocal inhibitory visual-vestibular interaction. Visual motion stimulation deactivates the parieto-insular vestibular cortex. Brain. 1998 Sep;121 ( Pt 9):1749-58. doi: 10.1093/brain/121.9.1749.
PubMed 9762962
Shumway-Cook A, Horak FB. Rehabilitation strategies for patients with vestibular deficits. Neurol Clin. 1990 May;8(2):441-57.
PubMed 2193221
Van Ombergen A, Heine L, Jillings S, Roberts RE, Jeurissen B, Van Rompaey V, Mucci V, Vanhecke S, Sijbers J, Vanhevel F, Sunaert S, Bahri MA, Parizel PM, Van de Heyning PH, Laureys S, Wuyts FL. Altered functional brain connectivity in patients with visually induced dizziness. Neuroimage Clin. 2017 Feb 28;14:538-545. doi: 10.1016/j.nicl.2017.02.020. eCollection 2017.
PubMed 28331800
15. D.S.C. Cruz-Neira & T. DeFanti, Surround-screen projection-based virtual reality: Design and implementation of the CAVE, in: Proceedings of SIGGRAPH, 1993; 135-142.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Virtual Reality and DVD Optokinetic Stimulation Exposure on Visual Induced Dizziness Symptoms in Persons With a Vestibular Disorder
ClinicalTrials.gov ID: NCT04649268
Acronym / sponsor ID: REC Reference: 20/LO/1244
Conditions: Peripheral Vestibular Disorder
Keywords: optokinetic stimulation, visually induced dizziness, vestibular, virtual reality, Oculus Quest headset
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 24 participants (estimated)
Lead sponsor: King's College LondonUniversity, hospital or other
Collaborators: University College, London
Study start: 28 Dec 2021 (estimated)
Primary completion: 28 Dec 2021 (estimated)
Study completion: 30 Jun 2022 (estimated)
First posted: 2 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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).

Arm	Type	Receives
Optokinetic stimulation treatment with visual motion DVDs	Active comparator	Other: Group ACustomised vestibular rehabilitation programme which includes optokinetic stimulation treatment with visual motion DVDs
Optokinetic stimulation treatment with Virtual Reality	Experimental	Device: Group BCustomised vestibular rehabilitation programme which includes optokinetic stimulation treatment with Virtual Reality environments delivered with headset (e.g. Oculus Quest headset)

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

clinical diagnosis of a peripheral vestibular disorder;
chronic dizziness and/or unsteadiness;
18 to 50 years old;
no previous rehabilitation or previous VRT programme completed with partial/no improvement;
willing to participate and to comply with the proposed training and testing regime; and

Key exclusion criteria (10 listed)

central nervous system involvement, excluding migraine. However, patients with severe migraine (> 3 migrainous headaches monthly) will be excluded.
fluctuating symptoms, for example, active Ménière disease;
acute orthopaedic disorders influencing balance control and gait;
a score of < 23/30 on the MoCA;
a score of >15/21 on the HADS for the depression component indicating significant depression symptoms;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Group BAlso: C2CARE Class I medical device: virtual environments, C2CARE PSY: C2 Physio 2019.2, Optokinetic stimulation treatment with Virtual RealityThe C2 CARE C2 Physio 2019.2 has been developed for physiotherapy rehabilitation purposes including vestibular disorders. Virtual reality environments will be provided via the VR Oculus Quest headset as part of the OKS exposure incorporated within a customised VRT programme. Participants will attend 45 minute individualised supervised sessions once weekly for 8 weeks. Participants in this rehabilitation group will also have a home-based exercise programme to practise on days not attending clinic. The home-based programme will incorporate customised VRT exercises with exposure to VR environments using the VR Oculus Quest headset.	Device	Optokinetic stimulation treatment with Virtual Reality
Group AAlso: Optokinetic stimulation treatment with visual motion DVDsOptokinetic stimulation treatment delivered through visual motion DVDs. Individualised 45 minute supervised sessions will occur for this group also once weekly for 8 weeks together with a home-based customised VRT programme incorporation the DVD to practise on days not attending clinic. Participants will have to use the OKS DVD for their exercises at home daily for 8 weeks as part of the prescribed home exercise programme.	Other	Optokinetic stimulation treatment with visual motion DVDs

Primary outcome

Situational Characteristics Questionnaire (SCQ)
Time frame: 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.

7 secondary outcomes

Functional Gait Assessment (FGA)
Time frame: 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)
Time frame: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).
Rod and Disc Test
Time frame: 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)
Time frame: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).
Montreal Cognitive Assessment (MoCA) Tool
Time frame: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).
Hospital Anxiety and Depression Scale (HADS)
Time frame: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).
Vertigo Symptom Scale (VSS)
Time frame: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
Results publication: PubMed 15316804Pavlou M, Lingeswaran A, Davies RA, Gresty MA, Bronstein AM. Simulator based rehabilitation in refractory dizziness. J Neurol. 2004 Aug;251(8):983-95. doi: 10.1007/s00415-004-0476-2.
Results publication: PubMed 19893191Bisdorff A, Von Brevern M, Lempert T, Newman-Toker DE. Classification of vestibular symptoms: towards an international classification of vestibular disorders. J Vestib Res. 2009;19(1-2):1-13. doi: 10.3233/VES-2009-0343. No abstract available.
Results publication: PubMed 26696853Indovina I, Riccelli R, Chiarella G, Petrolo C, Augimeri A, Giofre L, Lacquaniti F, Staab JP, Passamonti L. Role of the Insula and Vestibular System in Patients with Chronic Subjective Dizziness: An fMRI Study Using Sound-Evoked Vestibular Stimulation. Front Behav Neurosci. 2015 Dec 9;9:334. doi: 10.3389/fnbeh.2015.00334. eCollection 2015.
Results publication: PubMed 24057824Lempert T. Vestibular migraine. Semin Neurol. 2013 Jul;33(3):212-8. doi: 10.1055/s-0033-1354596. Epub 2013 Sep 21.
Results publication: PubMed 23077146Pavlou M, Bronstein AM, Davies RA. Randomized trial of supervised versus unsupervised optokinetic exercise in persons with peripheral vestibular disorders. Neurorehabil Neural Repair. 2013 Mar-Apr;27(3):208-18. doi: 10.1177/1545968312461715. Epub 2012 Oct 16.
Results publication: PubMed 23302708Pavlou M, Kanegaonkar RG, Swapp D, Bamiou DE, Slater M, Luxon LM. The effect of virtual reality on visual vertigo symptoms in patients with peripheral vestibular dysfunction: a pilot study. J Vestib Res. 2012;22(5-6):273-81. doi: 10.3233/VES-120462.
Results publicationCawthorne TE. The physiological basis for head exercises. J Chart Soc Physiother. 1944; 30:106-107.
Results publication: PubMed 21552732Morozetti PG, Gananca CF, Chiari BM. Comparison of different protocols for vestibular rehabilitation in patients with peripheral vestibular disorders. J Soc Bras Fonoaudiol. 2011 Mar;23(1):44-50. doi: 10.1590/s2179-64912011000100011. English, Portuguese.
Results publication: PubMed 10983955Whitney SL, Wrisley DM, Brown KE, Furman JM. Physical therapy for migraine-related vestibulopathy and vestibular dysfunction with history of migraine. Laryngoscope. 2000 Sep;110(9):1528-34. doi: 10.1097/00005537-200009000-00022.
Results publication: PubMed 12478402Dieterich M, Bense S, Stephan T, Yousry TA, Brandt T. fMRI signal increases and decreases in cortical areas during small-field optokinetic stimulation and central fixation. Exp Brain Res. 2003 Jan;148(1):117-27. doi: 10.1007/s00221-002-1267-6. Epub 2002 Nov 13.
Results publication: PubMed 12202076Kleinschmidt A, Thilo KV, Buchel C, Gresty MA, Bronstein AM, Frackowiak RS. Neural correlates of visual-motion perception as object- or self-motion. Neuroimage. 2002 Aug;16(4):873-82. doi: 10.1006/nimg.2002.1181.
Results publication: PubMed 9762962Brandt T, Bartenstein P, Janek A, Dieterich M. Reciprocal inhibitory visual-vestibular interaction. Visual motion stimulation deactivates the parieto-insular vestibular cortex. Brain. 1998 Sep;121 ( Pt 9):1749-58. doi: 10.1093/brain/121.9.1749.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Group B and Group A in people with Peripheral Vestibular Disorder, run by King's College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Situational Characteristics Questionnaire (SCQ) (time frame: Assessment of the change in this outcome will be performed at baseline (week 0) and end of treatment (week 10).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04649268, which also lists 48 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.