NCT04268615

Brief Summary

Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to a severe impairment of their quality of life. However, correcting saccades during rapid head movement, called covert-saccades, have been more recently identified. These saccades, which occur during the head movement in patients with vestibular hypofunction, present a very short latency. They could compensate for the lack of vestibular-ocular reflex and greatly decrease oscillopsia and visual impairment. The triggering of these covert-saccade is still not known. They could be of visual origin but the short latency is unusual. The objective of this study is to evaluate the potential role of visual trigger in 12 patients with chronic bilateral areflexia, using different visuo-vestibular conditions. The latency of simple visually guided saccades will also be tested in the group of patients and a group of 12 healthy controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2022

Completed
Last Updated

September 2, 2025

Status Verified

July 1, 2022

Enrollment Period

1.3 years

First QC Date

February 11, 2020

Last Update Submit

August 28, 2025

Conditions

Keywords

Saccadic Eye MovementsBilateral VestibulopathyBilateral Vestibular Hypofunction

Outcome Measures

Primary Outcomes (1)

  • Latency of covert-saccades

    Latency of covert saccades correspond to the time between the beginning of head impulse and the initiation of the first covert-saccade

    Day 1

Secondary Outcomes (4)

  • Frequency of covert-saccades

    Day 1

  • Velocity of covert-saccades

    day 1

  • Amplitude of covert-saccades

    Day 1

  • Latency of visually-guided saccades

    Day 1

Study Arms (2)

Patients

EXPERIMENTAL

Patients suffering from chronic bilateral vestibular hypofunction

Other: Covert Saccades and Virtual RealityOther: Actives versus passives Head ImpulsesOther: Visually guided saccades

healthy subject group

ACTIVE COMPARATOR
Other: Covert Saccades and Virtual RealityOther: Actives versus passives Head ImpulsesOther: Visually guided saccades

Interventions

During this intervention, patients will undergo head impulse testing while wearing virtual reality Headsets. During the head impulse tests the visual information will be modified in order to create a conflict between head rotation and rotation of the visual scene. Recording of head and eye movement will be done during these head impulses in order to verify if visual information modifies compensatory eye movements during head impulses.

Patientshealthy subject group

Patients will undergo classic passive head rotation as well as active head rotation in order to compare latencies of covert saccades in both conditions.

Patientshealthy subject group

Patients as well as healthy control subjects will undergo testing of visually guided saccades in different conditions (step, gap, overlap) in order to compare latencies of covert saccades between both groups.

Patientshealthy subject group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For all :
  • Age from 18 to 90
  • Understanding of the experimental instructions
  • Informed Consent
  • For Patients :
  • Bilateral vestibular hypofunction with regards to the criteria of the of the Barany Society A. Chronic vestibular syndrome with at least three of the following symptoms
  • Postural imbalance
  • Unsteadiness of gait
  • Movement-induced blurred vision or oscillopsia during walking or quick head/body movements
  • Worsening of postural imbalance or unsteadiness of gait in darkness and/or on uneven ground B. No symptoms while sitting or lying down under static conditions C. Bilaterally reduced or absent angular VOR function documented by
  • bilaterally pathological horizontal angular VOR gain \< 0.6, measured by the video-HIT5or scleral-coil technique and/or
  • reduced caloric response (sum of bithermal max. peak SPV on each side \< 6°/sec7)and/or
  • reduced horizontal angular VOR gain \< 0.1 upon sinusoidal stimulation on a rotatorychair (0.1 Hz, Vmax = 50°/sec).
  • D. Not better accounted for by another disease
  • \* For Healthy control No ENT or neurological disorders

You may not qualify if:

  • 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
  • Pregnant women
  • Patients under tutelage
  • Patient without social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

Related Publications (3)

  • Lagadec V, Pelisson D, Koun E, Robert C, Froment Tilikete C, Hermann R. Oculomotor compensatory strategies in bilateral vestibulopathy: Predictive and active conditions of head movements. J Vestib Res. 2025 Nov;35(6):290-299. doi: 10.1177/09574271251355180. Epub 2025 Jun 21.

    PMID: 40543046BACKGROUND
  • Hermann R, Ramat S, Colnaghi S, Lagadec V, Desoche C, Pelisson D, Froment Tilikete C. Catch-Up Saccades in Vestibulo-Ocular Reflex Deficit: Contribution of Visual Information? Ear Hear. 2025 May-Jun 01;46(3):719-728. doi: 10.1097/AUD.0000000000001616. Epub 2024 Dec 18.

    PMID: 39690450BACKGROUND
  • Desoche C, Verdelet G, Salemme R, Farne A, Pelisson D, Froment C, Hermann R. Virtual reality set-up for studying vestibular function during head impulse test. Front Neurol. 2023 Mar 29;14:1151515. doi: 10.3389/fneur.2023.1151515. eCollection 2023.

    PMID: 37064179BACKGROUND

MeSH Terms

Conditions

Reflex, AbnormalBilateral Vestibulopathy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Caroline FROMENT, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 13, 2020

Study Start

December 15, 2020

Primary Completion

March 21, 2022

Study Completion

March 21, 2022

Last Updated

September 2, 2025

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations