Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02480452 |
| Other study ID # |
S57844 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2015 |
| Est. completion date |
June 2019 |
Study information
| Verified date |
June 2015 |
| Source |
Universitaire Ziekenhuizen KU Leuven |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The overall goal of this research proposal is the early prediction of the emergence of CVI
and its characteristics on the basis of neuroimaging data.
The different steps that will be taken to achieve this goal will be:
1. To characterize CVI deficits in children;
2. To correlate the CVI characteristics with their motor profiles;
3. To characterize brain lesions in children with CVI;
4. To link the motor profile, CVI profile and brain metrics of the children.
Over the last 10 years, 488 children with and without CP have consulted at the CVI clinic in
Leuven. All these children had a comprehensive visual perceptual assessment, cognitive
evaluation and an ophthalmological assessment. Summarizing these data results in a
quantitative visual perceptual profile for each individual patient. The goal is to
prospectively extend this database to a number of 600 children. The project's primary
objective is to relate the presence of CVI to the motor profiles of these children.
Of these 488 children, 300 have an MRI available. The goal is to analyze the retrospective
MRI data of this clinical group and to prospectively extend this database by reassuring newly
registered children will receive MRI with DTI. This will allow the investigation of the
correlation between the brain metrics and the CVI characteristics in a large cohort.
Description:
Objective 1 &2: to investigate the relationship between the presence of CVI and the motor
profiles of children diagnosed with CVI.
Part 1 Retrospective data A database, registering all children diagnosed with or at risk for
CVI, is available through the Centre For Developmental Disabilities, Leuven. All these
children have consulted at the CVI clinic. Their developmental age ranges between 3 and 6
years. All these children have had a thorough work-up, so that information is available
regarding the diagnosis of CVI (L94 visual perceptual battery test score10 and CVI
questionnaire11), the cognitive abilities of the child (performance and verbal IQ using
WISC-II, SON-R or WPPSI-III-NL) together with the test results regarding motor functioning:
visuospatial functioning (VMI12 and TVPS13), motor coherence tasks and gross motor function
(movement ABC14).
All children standardly received a complete ophthalmological assessment. The consensus eye
protocol, as introduced by the Flemish working group on CVI, was performed in each child,
evaluating fixation of eyes, position and motility, acuity, refraction, contrast sensitivity,
visual field, visual attention and viewing distance.
Part 2 Prospective data The database will continuously be updated and therefore, data from
all new consulting children will be added consecutively.
Prospectively, a new test for the diagnosis of CVI will be applied. It concerns a newly
developed tool for diagnosis of CVI, based on the L-POST and developed in collaboration with
the research group of J. Wagemans. Normative data have been gathered for the age ranges 3 to
6 years. The diagnosis of CVI is made by comparing the results of the visual perceptual tests
to the developmental age of the child, with a result
