Covert-saccades, Dynamic Visual Acuity and Quality of Life
COSQOL
Quality of Life and Dynamic Visual Acuity in Patients With Bilateral Vestibulopathy: the Impact of Covert-saccades
1 other identifier
interventional
20
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2016
Shorter than P25 for not_applicable
1 active site
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
April 25, 2016
CompletedFirst Posted
Study publicly available on registry
April 27, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedSeptember 4, 2025
August 1, 2025
8 months
April 25, 2016
August 27, 2025
Conditions
Keywords
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
EXPERIMENTALPatients suffering from chronic bilateral vestibular hypofunction.
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.
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 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 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 is a 9 items questionnaires that identify oscillopsia in different circumstances.
Eligibility Criteria
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
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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caroline TILIKETE, MD
Institut National de la Santé Et de la Recherche Médicale, France
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