The Use of Virtual Reality for the Treatment of Visual Vertigo.

This study investigates the use of virtual environments presented on a head mounted display for the rehabilitation of those suffering with visual vertigo.

The control group and treatment groups will be presented with two different sets of environments and be given the same head and eye exercises to complete within the environment. They will also be provided with at home exercises to complete.

Study Overview

• Status: Unknown
• Conditions: Treatment of Visual Vertigo
• Intervention / Treatment: Other: Virtual environment with fast moving objects; Other: Virtual environment with no movement

Detailed Description

Visual vertigo occurs after the balance system suffers damage (e.g after a viral infection such as labyrinthitis). This causes an over-reliance on the eyes to maintain balance which causes disorientation in busy environments such as the supermarket. The treatment involves trying to desensitise the individual to visually stimulating situations. Further head and eye exercises are completed alongside the exposure to overcome the damage done to the balance system.

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kirsty M Walker, BSc; Phone Number: 011427112131; Email: kirsty.walker@sth.nhs.uk
• Study Contact Backup: Name: Paul Bacon, PhD; Phone Number: 01142712145; Email: paul.bacon@sth.nhs.uk

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2JF
      • Recruiting
      • Royal Hallamshire Hospital
      • Contact: Paul Bacon, PhD; Phone Number: 01142712145; Email: paul.bacon@sth.nhs.uk
      • Contact: Kirsty M Walker, BSc; Phone Number: 01142712131; Email: kirsty.walker@sth.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Those who have been diagnosed with visual vertigo and have scored a significant level on the Situational Characteristic Questionnaire (over 0.74 as per Pavlou et al., 2006).

Exclusion Criteria:

• Those with or under investigation for epilepsy.
• Those who have been determined to have no or limited balance function in both ears.
• Those with reduced visual acuity that will leave them unable to view the 3D effects of the head mounted display.
• Those with severe mental health disorders e.g. psychosis, paranoid disorders, bipolar disorder or a history of substance abuse.
• Severe neck pain/ restricted movement.
• Previous treatment for visual vertigo.
• Those with an fluctuating vestibular disorder such as Ménière's disease or vestibular migraine.
• Those with untreated Benign Paroxymal Positional Vertigo (BPPV).
• Those with a significant brain injury, or head injury that results in a central vestibular disorder.
• Those with an arrhythmia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment group; Virtual environment with fast moving objects these are graded in intensity from 1-7. Participants complete head and eye exercises within the environment using focus points such as benches and lanterns for a six week treatment program.	Other: Virtual environment with fast moving objects; A beach/park environment with graded moving objects, the individual will complete head and eye exercises.
ACTIVE_COMPARATOR: Control group; Virtual environment with no movement graded at grade 0. Participants complete head and eye exercises within the environment using focus points such as benches and lanterns for a six week treatment program.	Other: Virtual environment with no movement; A beach/park environment with static objects, the individual will complete head and eye exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in scoring on the Situational Characteristic Questionnaire	A measure of visual vertigo symptom level	Week 1 and Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in scoring on the PHQ-9 Questionnaire from week one to six	A measure of depression symptom level	Week 1 and Week 6
Change in scoring on the GAD-7 Questionnaire from week one to six	A measure of anxiety symptom level	Week 1 and Week 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective questionnaire	A likert scale based questionnaire assessing acceptability of treatment	Week 6
Change in head tracking observed at each weekly session for six weeks through numerical data extracted from the headset to show displacement of the head in the x, y and z planes of movement.	Analysis of the head movement within each environment each week to see if there is any improvement	Week 1, 2, 3, 4, 5 and 6

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborators: University of Manchester
• Investigators: Principal Investigator: Kirsty M Walker, BSc, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (ANTICIPATED): November 1, 2018

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (ESTIMATE): January 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2018
• Last Update Submitted That Met QC Criteria: April 12, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Dizziness
• Other Study ID Numbers: STH19451; 5375 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO