Covert-saccades, Dynamic Visual Acuity and Quality of Life

Vestibular Diseases Clinical Trial

— COSQOL  

Official title:

Quality of Life and Dynamic Visual Acuity in Patients With Bilateral Vestibulopathy: the Impact of Covert-saccades

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02753179
• Other study ID #: 69HCL15_0746
• Status: Completed
• Phase: N/A
• First received: April 25, 2016
• Last updated: January 13, 2017
• Start date: May 2016
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Vestibular Diseases

Intervention

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

Locations

Country	Name	City	State
France	Unité de Neuro-Ophtalmologie Hôpital Neurologique	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of life assessed with the 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	Day 0
Secondary	Dynamic visual acuity	Dynamic visual acuity is a measure of threshold for binocular reading of letters that are presented on a screen during head impulse test	day 0
Secondary	Oscillopsia severity questionnaire score	Oscillopsia severity questionnaire is a 9 items questionnaires that identify oscillopsia in different circumstances. A mean item score gives an oscillopsia severity score ranging from 1 to 5, yielding to a total score ranging from 0 to 45	day 0
Secondary	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 0