Covert-saccades, Dynamic Visual Acuity and Quality of Life

NCT ID: NCT02753179

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vestibular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bilateral vestibular hypofunction

Patients suffering from chronic bilateral vestibular hypofunction.

Group Type EXPERIMENTAL

Head Impulse Tests

Intervention Type OTHER

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.

Dynamic visual acuity Test (DVAT)

Intervention Type OTHER

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.

VEMPs & VEMPo

Intervention Type OTHER

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.

Dizziness Handicap Inventory

Intervention Type OTHER

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

Oscillopsia severity questionnaire

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Head Impulse Tests

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.

Intervention Type OTHER

Dynamic visual acuity Test (DVAT)

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.

Intervention Type OTHER

VEMPs & VEMPo

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.

Intervention Type OTHER

Dizziness Handicap Inventory

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

Intervention Type OTHER

Oscillopsia severity questionnaire

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Caroline TILIKETE, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Unité de Neuro-Ophtalmologie Hôpital Neurologique

Bron, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29248983 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

69HCL15_0746

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Vestibular Infant Screening - Rehabilitation
NCT06177132 NOT_YET_RECRUITING NA
Visual Attention and Eye Movements
NCT03298737 ENROLLING_BY_INVITATION
Treatment of Pendular Nystagmus in OPT
NCT02466191 COMPLETED PHASE4