NCT02753179

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 objective of this study is to evaluate the potential functional benefice of these compensatory movements in a population of 20 patients with chronic bilateral areflexia, in a cross-sectional study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

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

April 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

April 25, 2016

Last Update Submit

August 27, 2025

Conditions

Keywords

Bilateral vestibular hypofunctionVideo Head Impulse TestCovert-saccadesQuality of lifeDynamic visual acuity

Outcome Measures

Primary Outcomes (1)

  • Frequency of covert-saccades

    Frequency of covert saccades corresponds to the total amount of covert-saccades divided by the total amount of head impulse tests multiplied by 100.

    Day 0

Secondary Outcomes (4)

  • Quality of life assessed with the Dizziness Handicap Inventory

    Day 0

  • Dynamic visual acuity

    day 0

  • Oscillopsia severity questionnaire score

    day 0

  • Latency of covert-saccades

    Day 0

Study Arms (1)

Bilateral vestibular hypofunction

EXPERIMENTAL

Patients suffering from chronic bilateral vestibular hypofunction.

Other: Head Impulse TestsOther: Dynamic visual acuity Test (DVAT)Other: VEMPs & VEMPoOther: Dizziness Handicap InventoryOther: Oscillopsia severity questionnaire

Interventions

Head Impulse Tests are performed by the clinician who holds the patient's head in his hands, while he is looking straight at an earth-fixed target; then by turning the patient's head abruptly and unpredictably to the left or right, up or down through a small angle (only 10-20 degrees - not a large angle). 20 impulses in each directions (6) will be performed.

Bilateral vestibular hypofunction

Dynamic visual acuity Test (DVAT) assesses visual acuity during head movement relative to baseline static visual acuity. DVA will be assessed actively during self-generated rotations of the head in different directions.

Bilateral vestibular hypofunction

VEMPs \& VEMPo are sound evoked muscular contractions of the neck or eye. They are recorded using an evoked response computer, a sound generator, and surface electrodes to pick up neck or eye muscle activation.

Bilateral vestibular hypofunction

Dizziness Handicap Inventory is a questionnaire that identify difficulties that patient may be experiencing because of dizziness, yielding to a score ranging from 0 to 100

Bilateral vestibular hypofunction

Oscillopsia severity questionnaire is a 9 items questionnaires that identify oscillopsia in different circumstances.

Bilateral vestibular hypofunction

Eligibility Criteria

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

You may qualify if:

  • Bilateral Vestibular Hypofunction (BVH) with at least two of the tree following criteria
  • Mean peak slow phase velocity of 5°/s or less in bilateral bithermal (30 and 44°C) caloric irrigations
  • Pathologic Head-impulse test
  • VOR gain of \<0.25 on rotatory chair tests
  • Disorder present for over 6 month
  • Comprehension of the experiments instructions
  • Patient consent

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
  • Cervical rachis pathology with instability
  • Cochlear Implants
  • Non-stabilized medical disease
  • Pregnant women
  • Patients under tutelage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de Neuro-Ophtalmologie Hôpital Neurologique

Bron, 69500, France

Location

Related Publications (1)

  • Hermann R, Pelisson D, Dumas O, Urquizar C, Truy E, Tilikete C. Are Covert Saccade Functionally Relevant in Vestibular Hypofunction? Cerebellum. 2018 Jun;17(3):300-307. doi: 10.1007/s12311-017-0907-0.

    PMID: 29248983BACKGROUND

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Caroline TILIKETE, MD

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2016

First Posted

April 27, 2016

Study Start

May 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations