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Neuropsychological Impairment and Quality of Life in Neurofibromatosis Type 1

NCT01851135 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2016-07-06

No results posted yet for this study

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 neuropsychological deficits. In fact, cognitive impairment is currently considered as one of the most pervasive features of this genetic disorder but its relationship with the worsening of quality of life found in this population has not been directly investigated to date.

Secondary objectives of this study are (i) to compare neuropsychological and quality of life measures between patients and healthy controls matched by age, gender and education level, (ii) to contrast neuropsychological deficits incidence between patients and controls, and (iii) to differentiate NF1 children's self versus hetero-assessment of quality of life.

The main hypothesis of this study is that the neuropsychological impairment classically identified in this clinical population will be associated to the quality of life's worsening both in children and adults.

Conditions

  • Neurofibromatosis Type 1

Interventions

OTHER

Neuropsychological examination and quality of life measures

Sponsors & Collaborators

  • Université d'Angers (Angers, France)

    collaborator UNKNOWN

  • Association Neurofibromatoses et Recklinghaüsen

    collaborator UNKNOWN

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Sébastien Barbarot, MD · Nantes University Hospital

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01851135 on ClinicalTrials.gov