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Neuropsychological Impairment and Quality of Life in Neurofibromatosis Type 1


N/A
8 Years
59 Years
Open (Enrolling)
Both
Neurofibromatosis Type 1

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Trial Information

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.

Inclusion Criteria


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)

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)

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Quality of life as measured by the questionnaires used in children and adults

Outcome Description:

Several domains in relation with quality of life (self perception, well-being, social life, emotions, etc.)

Outcome Time Frame:

at day 0 for adults; at 4 weeks for children

Safety Issue:

No

Principal Investigator

Sébastien Barbarot, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Universitaire de Nantes

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

RC12_0130

NCT ID:

NCT01851135

Start Date:

Completion Date:

Related Keywords:

  • Neurofibromatosis Type 1
  • Quality of life
  • Neuropsychological disorders
  • Neurofibromatosis type 1
  • Neurofibromatoses
  • Neurofibromatosis 1
  • Osteitis Fibrosa Cystica

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