Status:
COMPLETED
Neuropsychological Impairment and Quality of Life in Neurofibromatosis Type 1
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
Université d'Angers (Angers, France)
Association Neurofibromatoses et Recklinghaüsen
Conditions:
Neurofibromatosis Type 1
Eligibility:
All Genders
8-59 years
Phase:
NA
Brief Summary
The main objective of the study is to investigate the determinants of the quality of life in children and adults with Neurofibromatosis type 1 (NF1) and more particularly the specific impact of neurop...
Detailed Description
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 1...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Patients :
- NF1 diagnosis following National Institutes of Health criteria (1988)
- Age: 8-12 years for children, 18-59 years for adults
- Signed informed written consent (parent and patient for children, patient for adults)
- French speaking
- Resident in France
- Inclusion Criteria for Healthy controls:
- Absence of NF1 diagnosis, learning disabilities, intellectual precocity
- Age: 8-12 years for children, 18-59 years for adults
- Signed informed written consent (parent and healthy control for children, healthy control for adults)
- French speaking
- Resident in France
- Exclusion Criteria:
- Uncorrectable hearing of visual impairment
- History of psychiatric illness
- Neuropsychological investigation in the last 6 months
- Insufficient language usage
- Any other known history of central nervous system pathology or neuropathological complications of NF1
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT01851135
Start Date
May 1 2013
End Date
April 1 2016
Last Update
July 6 2016
Active Locations (2)
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1
Assistance Publique - Hôpitaux de Paris (Hôpital Henri Mondor)
Créteil, France, 94010
2
Centre Hospitalier Universitaire de Nantes
Nantes, France, 44093