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Study of Oculomotor Dysfunction Leading to Children Vertigo (VERVE)

Primary Purpose

Vertigo, Headache, Anomaly of Vergence System

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
orthoptic rehabilitation
Orthoptic diagnostic
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vertigo focused on measuring Vergence-accommodation evaluation, Vergence and postural control, Dynamic visual acuity

Eligibility Criteria

6 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children with disorders of vergence:

    • 6 to 17 years old
    • Patient receiving a social security scheme
    • Presenting vergence problems (diagnosed by standard methods : prism bar using the proximal point of convergence and phoria) and suffering from vertigo and/or headache
    • Presenting anormal refraction
    • Free from any type vestibular pathology, ENT or neurological
    • Free from strabismus
    • Child and holders of parental authority have signed a consent

Healthy Children :

  • 6 to 17 years old
  • Free from any type of vestibular pathology, ENT or neurological
  • Free from any type of neuron-ophthalmic/orthoptic pathology
  • Child and holders of parental authority have signed a consent

Exclusion Criteria:

  • Patient with a disease which (from the assessment of the investigator) could disrupt the monitoring or be disrupted by the participation in the study,

Sites / Locations

  • ORL Service - Robert Debre Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Patients orthoptic rehabilitation

Control Orthoptic diagnostic

Arm Description

Children with vertigo-headache and vergence disorders

Healthy controls

Outcomes

Primary Outcome Measures

oculomotor complete evaluation (static and dynamic and accommodation), posturography test and a visual dynamic acuity test

Secondary Outcome Measures

free of symptoms

Full Information

First Posted
June 29, 2010
Last Updated
December 3, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Centre National de la Recherche Scientifique, France
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1. Study Identification

Unique Protocol Identification Number
NCT01153789
Brief Title
Study of Oculomotor Dysfunction Leading to Children Vertigo
Acronym
VERVE
Official Title
Evaluation and Medical Care of Oculomotor Dysfunction Leading to Vertigo in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Centre National de la Recherche Scientifique, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The eye movements of vergence allow binocular vision whatever the viewing distance or the body movements are and the perception of depth. Vergence dysfunction can lead to erroneous visual sensation of movements. In our daily life using screens (computer, game boys..) is increasing and this approach heavily the ocular vergence and can lead to symptoms if oculomotor and accommodative systems are dysfunctioning (Ped. Neurology 2000). Not knowing this pathology lead to inappropriate and expensive prescription CT scan or NMR. To evaluate the vergence performances just evaluation in static condition is currently available in ophthalmology departments. The CNRS laboratory (IRIS, FRE 3154) adapted a technic of eye movement recording to study ocular vergence in dynamic condition.
Detailed Description
The goals of the study are: to compare the coordination of binocular eye movements, postural stability on a force-plate during visual tasks (looking at a target or reading) and dynamic visual acuity between two groups of children and teenagers: one group with oculomotor vergence disorders and vertigo and one group with normal eye movements. Children will undergo complete vestibular testing (by Dr WIENER-VACHER) to eliminate a vestibular origin for vertigo. Normal children will be volunteers. in order to evaluate objectively the effect of rehabilitation, a second oculomotor evaluation (identical to the initial one) will be done in children with vertigo after an orthoptic rehabilitation focused on ocular vergence. We hypothesize that functional oculomotor disorders can be rehabilitated because of the plasticity of the oculomotor system (proved by several studies for many years) provided that the spatial temporal parameters of the training are precisely tailored to patient malfunction. Establish normative data of the binocular eye movements and posturography, and validate a protocol for complete static and dynamic oculomotor evaluation for clinical use. To a longer term modification of the rehabilitation protocols of eye movements will be designed to fit each patient problems in function of the abnormalities revealed by the static and dynamic evaluation. Study calendar : All the children referred for vertigo with vergence abnormalities and normal vestibular functional evaluation will be proposed for participate to the study. The patients included in the study will perform an oculomotor complete evaluation (static and dynamic and accommodation), posturography test and a visual dynamic acuity test. These tests will last for 60 minutes, including breaks to avoid fatigue of the children. Then, the children will follow orthoptic rehabilitation :12 sessions (2 sessions per week). These sessions will be done by an orthoptist installed close to home, in contact with the research team. At the end of a series of 12 sessions of orthoptic, the child will be examined and will again perform a static and dynamic oculomotor evaluation and control of postural balance. In order to highlight the prolonged effects of rehabilitation a third oculomotor evaluation and control of postural balance will be made six months after inclusion. Healthy children (control group) will be recruited at Robert Debré hospital. A poster campaign in the corridors of the hospital, as well as general information (mailing) for the Hospital staff will be made. A questionnaire prior to a half-hour will confirm the normal vestibular children. After completing the questionnaire, a test Postural oculomotor (one hour) and a test orthoptics (half hour) will be made. Conduct of Research: We will study with a multidisciplinary approach children with vergence abnormalities and vertigo and/or headache. Healthy children will also be examined for baseline data. Methodology : Statistical analysis will be conducted at the Unite de Recherche Clinique Paris Nord, Robert Debré Hospital. The qualitative data will be described in terms of frequency and percentages, quantitative data as mean (SD) if the distribution follows a normal distribution, as median (quartiles) otherwise. The influence of sex adjusted for age will be tested by parametric methods after normalization of distributions. The establishment of standards will be conducted according to the method described by EM Wright et P. ROYSTON (Simplified estimation of age-specific reference intervals for skewed data, Statistics in Medicine 1997, vol 16, 2785-2803). The method is to produce smoothed percentile curves by time (age) using parametric methods. Analysis of sick children will be purely descriptive. She will describe the differences for different standard deviation scores of variables described in the previous paragraph between the time of diagnosis and after 12 weeks of rehabilitation and orthoptic vergence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo, Headache, Anomaly of Vergence System, Accommodation Disorders, Orthoptic Rehabilitation
Keywords
Vergence-accommodation evaluation, Vergence and postural control, Dynamic visual acuity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients orthoptic rehabilitation
Arm Type
Experimental
Arm Description
Children with vertigo-headache and vergence disorders
Arm Title
Control Orthoptic diagnostic
Arm Type
Other
Arm Description
Healthy controls
Intervention Type
Procedure
Intervention Name(s)
orthoptic rehabilitation
Intervention Description
Orthoptic rehabilitation: 12 sessions (2 sessions per week) At the end of a series of 12 sessions of orthoptic, the child will be examined and will again perform an static and dynamic oculomotor evaluation and control of postural balance.
Intervention Type
Other
Intervention Name(s)
Orthoptic diagnostic
Intervention Description
postural, oculomotor and orthoptics tests
Primary Outcome Measure Information:
Title
oculomotor complete evaluation (static and dynamic and accommodation), posturography test and a visual dynamic acuity test
Time Frame
t=0, t=3months, t=6months
Secondary Outcome Measure Information:
Title
free of symptoms
Time Frame
t=3months, t=6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children with disorders of vergence: 6 to 17 years old Patient receiving a social security scheme Presenting vergence problems (diagnosed by standard methods : prism bar using the proximal point of convergence and phoria) and suffering from vertigo and/or headache Presenting anormal refraction Free from any type vestibular pathology, ENT or neurological Free from strabismus Child and holders of parental authority have signed a consent Healthy Children : 6 to 17 years old Free from any type of vestibular pathology, ENT or neurological Free from any type of neuron-ophthalmic/orthoptic pathology Child and holders of parental authority have signed a consent Exclusion Criteria: Patient with a disease which (from the assessment of the investigator) could disrupt the monitoring or be disrupted by the participation in the study,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvette R WIENER, M.D., PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thierry VAN DEN ABBEELE, M.D., PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
ORL Service - Robert Debre Hospital
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

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