NCT06213792

Brief Summary

The vestibulo-ocular reflex (VOR) stabilizes the gaze during rapid head movements by inducing an eye rotation of equivalent amplitude but in the opposite direction to the head rotation. Normally, the ratio of eye rotation amplitude to head rotation, or VOR gain, is 1. Under some conditions such as growth or the use of corrective glasses, this gain is adapted to the new visuo-vestibular conditions. This well-known sensorimotor adaptation phenomenon can be achieved through the experimental creation of a conflict between vestibular and visual information. Incremental velocity error (IVE) allows for a rapid adaption of the VOR at high speed by synchronously projecting a laser target that moves to create a progressively increasing visuo-vestibular conflict. However, this method does not correspond to the ecological conditions of VOR use, as the training is conducted in darkness and the visuo-vestibular conflict does not involve the entire visual scene. Recreating this type of adaptation in a virtual reality environment could allow for adaptation with a visual stimulus involving the entire visual scene, thus more closely resembling the physiological conditions of VOR use. We hypothesize that a visual simulation of the entire scene would be more effective than an isolated target in VOR adaptation during high velocity head rotation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 4, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2024

Completed
Last Updated

May 16, 2024

Status Verified

April 1, 2024

Enrollment Period

28 days

First QC Date

January 10, 2024

Last Update Submit

May 15, 2024

Conditions

Keywords

Vestibulo-Ocular ReflexAdaptationHead Impulse TestVirtual Reality

Outcome Measures

Primary Outcomes (1)

  • VOR gain

    VOR gain corresponds to the amplitude of the eye rotation devided by the amplitude of the head rotation for a given head impulse.

    7 days

Interventions

Subjects will undergo adaptation of their VOR in virtual reality in two different conditions. The side on which the adaptation will take place and the type of condition with which the patients will start will be randomized. Subject will undergo passive rapid head movements done by an experienced examinator whilst fixing a target in front of them. The movement of the target relative to the movement of the head will increase every 90 seconds by 10% until the movement of the visual scene is twice that of the head movement. In one condition the visual scene will be only a target in a grey void. In the other condition the visual scene will be more complex and represent a target in the room in which the subject is seated. Subjects will undergo both conditions at least 7 days apart.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy subjects

You may qualify if:

  • Age from 18 to 60
  • Understanding of the experimental instructions
  • Informed Consent

You may not qualify if:

  • Underlying ENT or neurological disorders
  • Corrected Visual Acuity lower than 5/10
  • Other conditions leading to oscillopsia or ataxia
  • Oculomotor palsy, ocular instability in primary position
  • Treatment that may affect ocular motility (psychotropes)
  • Cervical rachis pathology with instability
  • Cochlear Implants
  • Non-stabilized medical disease
  • Subject suffering from debilitating motion sickness or Virtual Reality sickness
  • Pregnant women
  • Patients under tutelage
  • Patient without social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Neurologique

Bron, 69677, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 19, 2024

Study Start

April 4, 2024

Primary Completion

May 2, 2024

Study Completion

May 2, 2024

Last Updated

May 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations