VertigoVERVENCT01153789
Study of Oculomotor Dysfunction Leading to Children Vertigo
A study testing orthoptic rehabilitation and Orthoptic diagnostic in people with Vertigo and Headache, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Vertigo, Headache, Anomaly of Vergence System
- What is being tested?
- orthoptic rehabilitation and Orthoptic diagnostic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- Patient with a disease which (from the assessment of the investigator) could disrupt the monitoring or be disrupted by the participation in the study,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation and Medical Care of Oculomotor Dysfunction Leading to Vertigo in Children
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.
Read the 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.
- Conditions
- Vertigo, Headache, Anomaly of Vergence System, Accommodation Disorders, Orthoptic Rehabilitation
- Being tested
- orthoptic rehabilitation, Orthoptic diagnostic
- Keywords
- Vergence-accommodation evaluation, Vergence and postural control, Dynamic visual acuity
- Medical subject headings
- Vertigo, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthoptic rehabilitationProcedure or surgery
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.
Orthoptic diagnosticOther
postural, oculomotor and orthoptics tests
| Study group | Role | What they receive |
|---|---|---|
| Patients orthoptic rehabilitation | Experimental | Children with vertigo-headache and vergence disorders Receives: Procedure: orthoptic rehabilitation |
| Control Orthoptic diagnostic | Other | Healthy controls Receives: Other: Orthoptic diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
oculomotor complete evaluation (static and dynamic and accommodation), posturography test and a visual dynamic acuity test
Measured: t=0, t=3months, t=6months
Secondary outcomes (1)
free of symptoms
Measured: t=3months, t=6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VertigoStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
- Investigators
- Sylvette R WIENER, M.D., PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisThierry VAN DEN ABBEELE, M.D., PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153789
- Sponsor's protocol ID
- P081114
- Acronym
- VERVE
- Status last verified
- Aug 2013
- First submitted
- 29 Jun 2010
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Medical Care of Oculomotor Dysfunction Leading to Vertigo in Children
- ClinicalTrials.gov ID
- NCT01153789
- Acronym / sponsor ID
- VERVE / P081114
- Conditions
- Vertigo, Headache, Anomaly of Vergence System, Accommodation Disorders, Orthoptic Rehabilitation
- Keywords
- Vergence-accommodation evaluation, Vergence and postural control, Dynamic visual acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- Sep 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients orthoptic rehabilitation | Experimental | Procedure: orthoptic rehabilitationChildren with vertigo-headache and vergence disorders |
| Control Orthoptic diagnostic | Other | Other: Orthoptic diagnosticHealthy controls |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Children with disorders of vergence:
- 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
Key exclusion criteria (1 listed)
- Patient with a disease which (from the assessment of the investigator) could disrupt the monitoring or be disrupted by the participation in the study,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orthoptic rehabilitationOrthoptic 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. | Procedure or surgery | Patients orthoptic rehabilitation |
| Orthoptic diagnosticpostural, oculomotor and orthoptics tests | Other | Control Orthoptic diagnostic |
Primary outcome
oculomotor complete evaluation (static and dynamic and accommodation), posturography test and a visual dynamic acuity test
Time frame: t=0, t=3months, t=6months
1 secondary outcome
free of symptoms
Time frame: t=3months, t=6months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvette R WIENER, M.D., PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Thierry VAN DEN ABBEELE, M.D., PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orthoptic rehabilitation and Orthoptic diagnostic in people with Vertigo and Headache, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oculomotor complete evaluation (static and dynamic and accommodation), posturography test and a visual dynamic acuity test (time frame: t=0, t=3months, t=6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.