The effect of simvastatin on the cognitive deficits of children with neurofibromatosis I (NF1): a randomised, double-blind placebo-controlled study
- Conditions
- eurofibromatosis type 1 (NF1)Nervous System DiseasesPhakomatoses, not elsewhere classified
- Registration Number
- ISRCTN14965707
- Lead Sponsor
- Erasmus Medical Center (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
1. Children aged between 8 and 16 years
2. NF1 diagnosis according to the criteria of the National Institutes of Health
3. Visiting the multidisciplinary NF1-outpatient clinic at the Erasmus MC-Sophia Children's Hospital
4. Informed consent
1. Pathology of the central nervous system (CNS) (hydrocephalus, epilepsy, radiotherapy, neurosurgery etc.)
2. Deafness and/or severely impaired vision
3. Use of anti-epileptics and/or neuroleptics
Additional exclusion criteria (under METC review as of 2nd May 2006):
4. Insufficient cognitive abilities to obtain a reliable score on a verbal IQ test (WISC-RN)
5. Contra-indications for simvastatin-treatment
6. Planned hospitalisation within three months after planned date of inclusion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Performance on neuropsychological tests on visuospatial memory and attention after 1 and 3 months (Rey Complex Figure test [recall], Bourdon Vos Test)<br>2. Performance on neurophysiological tests on adaptation of eye movements after 1 and 3 months (saccade-adaptation test, adaptation of eye-hand coordination)<br>3. Measurement of the size, number, localization and spectra of unidentified bright objects (UBOs), hyperintensities on T2 weighed magnetic resonance imaging (MRI) and 3D CSI 1H magnetic resonance spectroscopy (MRS) after 3 months
- Secondary Outcome Measures
Name Time Method