Neurofibromatosis 1
Conditions
Interventions
Participants are treated for 12 months with Simvastatin (10 mg/d in month 1, 20 mg/d in month 2, and then 20 mg/d for participants 8-12 years old or 40 mg/d for participants 13-16 years old) or equiva
Sponsors
Erasmus MC – Sophia’s Children Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 8 to 16 years; 2. NF1 diagnosis with genetic confirmation; 3. Oral and written informed consent from parents and participants aged older than 12 years.
Exclusion criteria
Exclusion criteria: 1. Segmental NF1; 2. Pathology of the CNS (other than asymptomatic gliomas); 3. Deafness; 4. Severely impaired vision; 5. Use of ADHD-medication; 6. Use of anti-epileptic drugs; 7. Use of anti-psychotic medication; 8. Use of Simvastatin; 9. Insufficient comprehension or production of the Dutch language; 10. An IQ below 48.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cognitive Function: WISC III-R; 2. Behavioral Problems on the Child Behavioral Checklist (CBCL, parents): internalizing behavioral problems, attention problems. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. School performance: Teacher ratings form the Teacher Report Form; 2. Quality of Life: CHQPF50 Child Quality of Life Questionnaire; 3. Behavior (other): internalizing problems rated by children on the Youth Self Report; 4. Cognitive Function (other): Non-verbal Long term Memory by the Rey Complex Figure test – delayed recall; 5. Attention (other): Stroop color word test; 6. Fine motor coordination: Grooved Pegboard test. | — |
Contacts
Public ContactM.H.T. Vaart, van der
Postbus 2040
Outcome results
None listed