The effect of simvastatin on the cognitive deficits of children with Neurofibromatosis I (NF1): a randomized, double-blind placebo-controlled study.

Completed

Conditions: eurofibromatosis type 1 is the most common single gene disease causing learning disabilities in humans. Children with NF1 commonly have cognitive dysfunctions like learning and attention deficits as well as impaired motor coordination. Half of the children seen at the multidisciplinary NF1 outpatient clinic of the Sophia Children's Hospital attends special education.

Registration Number: NL-OMON21351

Lead Sponsor: Erasmus MC afd. Neurowetenschappen, Dr. Y. Elgersma

Brief Summary: http://www.ncbi.nlm.nih.gov/pubmed?term=18632543

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Children aged between 8 and 16 years, NF1 diagnosis according to the criteria of the National Institutes of Health, visiting the multidisciplinary NF1-outpatient clinic at the Erasmus MC – Sophia Children’s Hospital; informed consent .

Exclusion Criteria

Pathology of the CNS (hydrocephalus, epilepsy, radiotherapy, neurosurgery, etc.), deafness and/or severely impaired vision, use of anti-epilepics and/or neuroleptics.

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 /><br>2. Performance on neurofysiological tests on adaptation of movements after 1 and 3 months (saccade-adaptation test, adaptation of eye-hand coordination);<br /><br>3. Measurement of the size, number, localization and spectra of UBO’s (unidentified bright objects, hyperintensities on T2 weighed MRI), on T2 MRI and 3D CSI 1H-MRS after 3 months.

Secondary Outcome Measures