Neuropsychological Impairment and Quality of Life in Neurofibromatosis Type 1
The study cohort will consist of 150 patients with NF1 (100 adults and 50 children)
recruited from the Neurofibromatosis Clinic at the University Hospital in Nantes and Créteil
(France). A sample of 150 healthy controls (100 adults and 50 children) will also be
recruited from sport and leisure clubs to serve as a normally developing control group.
The protocol assessment includes a standard and thorough neuropsychological examination
specific to children and adults, to investigate the different aspects of cognitive domains:
language, visuoperceptive and visuomotor abilities, memory, attention, executive function
and intelligence skills. Quality of life is measured by a questionnaire specifically adapted
to children and adults.
Other factors linked to the NF1 disease (familial or sporadic form, severity and visibility)
and to demographic characteristics (sex, age, education level) will be taken into account
to study their respective impact on quality of life, as compared with neuropsychological
measures.
Interventional
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Quality of life as measured by the questionnaires used in children and adults
Several domains in relation with quality of life (self perception, well-being, social life, emotions, etc.)
at day 0 for adults; at 4 weeks for children
No
Sébastien Barbarot, MD
Principal Investigator
Centre Hospitalier Universitaire de Nantes
France: Agence Nationale de Sécurité du Médicament et des produits de santé
RC12_0130
NCT01851135
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